Akupresura punktu usznego w leczeniu neuropatii wywołanej chemioterapią
9 lipca 2026 zaktualizowane przez: Jennifer Kawi, The University of Texas Health Science Center, Houston
Proponowane randomizowane badanie kontrolne oceni akupresurę punktu usznego (APA) w neuropatii wywołanej chemioterapią (CIN), rygorystycznie biorąc pod uwagę specyficzność punktową i efekty placebo poprzez integrację pomiarów samoopisowych, pomiarów psychofizycznych (QST), endogennych biomarkerów (cytokin) i neuro -obrazowanie w celu zbadania skuteczności APA i leżącego u jej podstaw mechanizmu(ów).
Badacze wykorzystają randomizowaną próbę kontrolną, projekt trzech grup: (1) grupa APA, (2) kontrola pozorowana APA i (3) kontrola zwykłej opieki. Aplikacja na smartfony do chwilowej oceny ekologicznej (EMA) zostanie wykorzystana do monitorowania przestrzegania APA i rejestrowania chwilowej ciężkości CIN oraz użycia środków przeciwbólowych.
Przegląd badań
Status
Zakończony
Szczegółowy opis
Neuropatia wywołana chemioterapią (CIN) – ból, drętwienie lub mrowienie w dłoniach i stopach – powoduje uporczywe objawy wpływające na czucie i równowagę u osób, które przeżyły raka. Do 50% osób, które przeżyły raka, nadal cierpi na CIN 6 lat po leczeniu. Stwierdzono, że duloksetyna, jedyny lek zalecany przez Amerykańskie Towarzystwo Onkologii Klinicznej, jest lepsza od placebo, ale poprawia CIN tylko o 0,73 punktu (skala 0-10). Nie ustalono skutecznego leczenia CIN poza ćwiczeniami fizycznymi, z wielkością efektu <0,508. Opioidy łagodzą ból CIN, ale ich długotrwałe stosowanie jest zdecydowanie odradzane ze względu na nadużywanie opioidów.
Badacze proponują przetestowanie akupresury punktów uszu (APA), innowacyjnego i skalowalnego rozwiązania opracowanego na podstawie akupunktury uszu. APA jest nieinwazyjną (bezigłową) i aktywną metodą leczenia pacjentów z bólem, podczas gdy akupunktura jest metodą inwazyjną (przy użyciu igieł) i pasywną (stosowaną przez licencjonowanego lekarza). W APA małe nasiona są przyklejane do określonych punktów uszu przez wykwalifikowanego dostawcę, a pacjenci naciskają na nasiona, aby stymulować punkty uszu trzy razy dziennie, przez trzy minuty, łącznie przez dziewięć minut dziennie. APA zapewnia ulgę w bólu w ciągu 1-2 minut po stymulacji ucha i utrzymuje ulgę w bólu przez jeden miesiąc po 4-tygodniowej interwencji APA. APA jest popularna na Tajwanie, w Chinach iw Europie. Chociaż jego stosowanie jest rzadkie w Stanach Zjednoczonych, ograniczona liczba badań klinicznych potwierdziła APA w leczeniu bólu.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
238
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Maryland
-
Baltimore, Maryland, Stany Zjednoczone, 21205
- Johns Hopkins University
-
-
Texas
-
Houston, Texas, Stany Zjednoczone, 77030
- The University of Texas Health Science Center at Houston
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Tak
Opis
Kryteria przyjęcia:
- pacjentów onkologicznych w wieku ≥18 lat
- otrzymali lek należący do jednej z następujących kategorii: platyna, alkaloidy barwinka, bortezomib, erybulina i/lub taksany
- ukończyli kurs chemioterapii na trzy miesiące lub dłużej przed włączeniem do badania
- mają CIN z powodu otrzymywania chemioterapii neurotoksycznej z powodu raka lub mają wcześniej istniejącą neuropatię obwodową o innej etiologii, która pogorszyła się po chemioterapii
- mają jedno z przeciętnych natężeń bólu, drętwienia lub mrowienia kończyn z poprzedniego tygodnia z powodu CIN ≥ 4 w 11-punktowej skali numerycznej.
Kryteria wyłączenia:
- stosowanie eksperymentalnego środka przeciwbólowego jednocześnie lub w ciągu ostatnich 30 dni
- zastosowanie wszczepialnego systemu dostarczania leków, np. Medtronic SynchroMed®
- wcześniejsza blokada splotu trzewnego lub inne neurolityczne leczenie przeciwbólowe
- inne zidentyfikowane przyczyny bolesnych parestezji występujące przed chemioterapią (np. pleksopatia popromienna lub złośliwa, radikulopatia lędźwiowa lub szyjna),
- uczulenie na lateks (taśmy do APA zawierają lateks).
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Akupresura punktu usznego (APA)
Zespół APA otrzyma cotygodniowe zabiegi osobiste oraz aplikację na smartfony z filmami ułatwiającymi zrozumienie i stosowanie APA.
Ramię APA weźmie udział w jednym osobistym rozmieszczeniu nasion oraz szkoleniu dla uczestnika lub jego opiekuna w zakresie umieszczania nasion w punktach usznych, a także jednym spotkaniu Zoom 1 tydzień po pierwszej wizycie u uczestnika coachingu i/lub opiekuna w zakresie nasion umieszczenie.
|
Osobiste umieszczanie nasion i szkolenie dla uczestnika lub jego opiekuna w zakresie umieszczania nasion w punktach usznych.
Sesja Zoom dotycząca rozmieszczania nasion i coachingu APA, która odbędzie się po wstępnym szkoleniu APA i rozmieszczania nasion (szkolenie wstępne odbywa się osobiście lub odbywa się zgodnie z filmami w aplikacji na smartfony).
|
|
Eksperymentalny: Wirtualna akupresura punktu usznego (vAPA)
Ramię vAPA samodzielnie poda APA, umieszczając nasiona zgodnie z instrukcją wideo znajdującą się w aplikacji na smartfony, która pomaga zrozumieć i administrować APA.
Uczestnik i/lub opiekun będzie postępował zgodnie z instrukcjami wideo dotyczącymi umieszczania nasion i otrzyma jedną sesję Zoom w ramach coachingu APA tydzień po wizycie podstawowej.
|
Sesja Zoom dotycząca rozmieszczania nasion i coachingu APA, która odbędzie się po wstępnym szkoleniu APA i rozmieszczania nasion (szkolenie wstępne odbywa się osobiście lub odbywa się zgodnie z filmami w aplikacji na smartfony).
Samodzielnie podawaj APA, umieszczając nasiona zgodnie z instrukcją wideo znajdującą się w aplikacji na smartfona, która pomoże Ci zrozumieć i administrować APA.
Uczestnik i/lub opiekun będzie postępował zgodnie z instrukcją wideo dotyczącą umieszczania nasion.
Inne nazwy:
|
|
Aktywny komparator: Zwykła kontrola opieki
Oddział zwykłej opieki będzie kontynuował swoją zwykłą opiekę.
|
Uczestnicy będą nadal objęci standardową opieką onkologa.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Pain Severity as Assessed by the Brief Pain Inventory
Ramy czasowe: Baseline, 1 month after baseline
|
Brief Pain Inventory (BPI) assesses worst pain severity.
The scale ranges from 0 (no pain) to 10 (severe pain), a higher score indicates greater pain
|
Baseline, 1 month after baseline
|
|
Numbness as Assessed by the Brief Pain Inventory
Ramy czasowe: Baseline, 1 month after Baseline
|
Brief Pain Inventory (BPI) assesses worst numbness.
The scale ranges from 0 (no numbness) to 10 (severe numbness), a higher score indicates greater numbness.
|
Baseline, 1 month after Baseline
|
|
Tingling as Assessed by the Brief Pain Inventory
Ramy czasowe: Baseline, 1 month after baseline
|
Brief Pain Inventory (BPI) assesses worst Tingling.
The scale ranges from 0 (no tingling) to 10 (severe tingling), a higher score indicates greater tingling.
|
Baseline, 1 month after baseline
|
|
Stiffness as Assessed by the Brief Pain Inventory
Ramy czasowe: Baseline, 1 month after baseline
|
Brief Pain Inventory (BPI) assesses worst stiffness.
The scale ranges from 0 (no stiffness) to 10 (severe stiffness), a higher score indicates greater stiffness.
|
Baseline, 1 month after baseline
|
|
Grade of Peripheral Motor Neuropathy as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4
Ramy czasowe: Baseline, 1 month after baseline
|
Peripheral motor neuropathy is graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Severity is graded on a scale that ranges from 1 to 5, with higher grade indicating greater severity of neuropathy.
|
Baseline, 1 month after baseline
|
|
Grade of Peripheral Sensory Neuropathy as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4
Ramy czasowe: Baseline, 1 month after baseline
|
Peripheral sensory neuropathy is graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Severity is graded on a scale that ranges from 1 to 5, with higher grade indicating greater severity of neuropathy.
|
Baseline, 1 month after baseline
|
|
Physical Function as Assessed by The Revised BPI-CIN Pain Interference Subscale
Ramy czasowe: Baseline, 1 month after Baseline
|
The BPI-CIN Interference subscale will be used to measure physical function caused by CIN.
The seven items evaluate interference with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life.
Each item is rated on a 0-10 numeric scale (0 = does not interfere; 10 = completely interferes).
The overall score is calculated as the mean of the seven items with a total score ranging from 0 to 10 to determine the level of interference, with higher scores indicating greater interference.
|
Baseline, 1 month after Baseline
|
|
Functional Ability as Assessed by Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
Ramy czasowe: Baseline, 1 month after Baseline
|
The ECOG Performance Status Scale describes level of functioning in terms of ability to care for oneself, daily activity, and physical. Score on the ECOG ranges from 0 (fully active and able) to 5 (dead) with higher score indicating lower function: 0 - Fully active, able to carry on all pre-disease performance without restriction
|
Baseline, 1 month after Baseline
|
|
Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Physical Function Subscale
Ramy czasowe: Baseline, 1 month after baseline
|
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - physical function subscale assesses physical function using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate better physical function.
|
Baseline, 1 month after baseline
|
|
Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Fatigue Subscale
Ramy czasowe: Baseline, 1 month after baseline
|
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - fatigue subscale assesses fatigue using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater fatigue.
|
Baseline, 1 month after baseline
|
|
Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Pain Interference Subscale
Ramy czasowe: Baseline, 1 month after baseline
|
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - pain interference subscale assesses how pain interferes with daily activities using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater pain interference.
|
Baseline, 1 month after baseline
|
|
Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Depression Subscale
Ramy czasowe: Baseline, 1 month after baseline
|
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - depression subscale assesses depression using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater depression severity.
|
Baseline, 1 month after baseline
|
|
Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Anxiety Subscale
Ramy czasowe: Baseline, 1 month after baseline
|
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - anxiety subscale assesses anxiety using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater anxiety.
|
Baseline, 1 month after baseline
|
|
Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Sleep Disturbance Subscale
Ramy czasowe: Baseline, 1 month after baseline
|
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - sleep disturbance subscale assesses sleep disturbance using 4 items, each scored on a 5-point Likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater sleep disturbance.
|
Baseline, 1 month after baseline
|
|
Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Ability to Participate in Social Activities Subscale
Ramy czasowe: Baseline, 1 month after baseline
|
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - ability to participate in social activities subscale assesses a participant's perceived ability to engage in usual social roles and activities using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate better and higher functioning social participation.
|
Baseline, 1 month after baseline
|
|
Upper Limb Function as Assessed by the Quick Dash Index
Ramy czasowe: Baseline, 1 month after baseline
|
The QuickDASH Index assesses upper limb disability and symptoms.
It evaluates limitations in daily activities (e.g., opening jars, performing housework), as well as pain, tingling, and sleep disturbances.
The total score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating greater disability.
|
Baseline, 1 month after baseline
|
|
Symptoms Severity as Assessed by the MD Anderson Symptom Severity Inventory
Ramy czasowe: Baseline, 1 month after Baseline
|
The MD Anderson Sympton Severity Inventory assesses severity of 13 common symptoms experienced by patients with cancer.
Each item is rated on a 0-10 numeric scale (0 = not present; 10 = as bad as you can imagine).
The overall symptom severity score is calculated as the mean of the 13 items with a range of 0 to 10, higher scores indicating greater symptom severity.
|
Baseline, 1 month after Baseline
|
|
Pain Self Efficacy as Assessed by Pain Self-Efficacy Questionnaire (PSEQ)
Ramy czasowe: Baseline, 1 month after Baseline
|
Pain self-efficacy is assessed using the Pain Self-Efficacy Questionnaire (PSEQ).
This 10-item instrument measures a participant's confidence in performing daily activities, social life and function despite pain.
Each item is rated on a 0-6 scale (0 = Not at all confident; 6 = Completely confident) and total score ranges from 0 to 60, with higher scores indicating greater self-efficacy and greater confidence in coping.
|
Baseline, 1 month after Baseline
|
|
Psychological Impact of Pain as Assessed by the Pain Catastrophizing Score
Ramy czasowe: Baseline, 1 month after Baseline
|
The Pain Catastrophizing Scale (PCS) assesses components of catastrophizing: rumination, magnification, and helplessness.
The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing.
|
Baseline, 1 month after Baseline
|
|
Number of Chronic Overlapping Pain Conditions as Assessed by the Chronic Overlapping Pain Conditions (COPC)
Ramy czasowe: Baseline, 1 month after Baseline
|
Chronic Overlapping Pain Conditions (COPC) are assessed using the Chronic Overlapping Pain Conditions Screener (COPCS).
This instrument identifies the presence of up to 10 common chronic pain conditions.
The COPC total score is calculated as the number of positively identified conditions (answered "Yes"), with higher scores indicating greater pain impact, central sensitization, and severity.
|
Baseline, 1 month after Baseline
|
|
Charlson Comorbidity Index
Ramy czasowe: Baseline
|
The Charlson Comorbidity index assesses a participant's comorbidity burden and predicted risk of mortality.
The total score ranges from 0 to 37. A higher score indicates greater comorbidity burden and higher risk of mortality.
|
Baseline
|
|
Pain Impact as Assessed by Pain, Enjoyment and General Activity (PEG) Scale
Ramy czasowe: Baseline, 1 month after baseline
|
Pain, Enjoyment and General Activity (PEG) is a three-item questionnaire that assesses pain intensity and its impact patient's daily life.
Each item is rated on a 0-10 scale.
The PEG score is calculated as the mean of three items, resulting in score range of 0 to 10, with a higher scores indicating greater pain severity and functional interference.
|
Baseline, 1 month after baseline
|
|
Number of Participants Reporting Opioid Use
Ramy czasowe: Baseline, Day 28
|
Baseline, Day 28
|
|
|
Opioid Use Per Day as Measured by the Morphine Milligram Equivalents (MME) Per Day
Ramy czasowe: Baseline, Day 28
|
Opioid use will be collected via EMA diary using a questionnaire.
Milligram Morphine Equivalent (MME) will be determined by using an equivalency factor to calculate a dose of morphine equivalent to the ordered opioid.
Daily morphine equivalent dosing is sum of the MME of all opioids a patient is likely to take within 24 hours, and will be calculated to MME for analysis.
Baseline was defined as the first day of opioid use recorded in the EMA diary.
|
Baseline, Day 28
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)-Trapezius
Ramy czasowe: Baseline, 1 month after Baseline
|
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM).
To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm^2) per second to the participant's trapezius and thumbs.
Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful."
The pressure at which participants indicated that the pressure sensation ''first becomes painful" is reported.
|
Baseline, 1 month after Baseline
|
|
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)-Thumb
Ramy czasowe: Baseline, 1 month after Baseline
|
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM).
To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm^2) per second to the participant's trapezius and thumbs.
Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful."
The pressure at which participants indicated that the pressure sensation ''first becomes painful" is reported.
|
Baseline, 1 month after Baseline
|
|
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Mechanical Temporal Summation (MTS)
Ramy czasowe: Baseline, 1 month after Baseline
|
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM).
To assess MTS, a single pinprick stimulus (e.g., via a weighted pinprick stimulator or Neuropen) is applied, followed by a series of 10 rapid, identical stimuli at the same location, usually at a rate of 1/second, to measure the change in pain sensation.
Participants rate their pain after the stimuli using a Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 = no pain and 10 = worst pain imaginable.
A higher score means greater pain sensitivity and increased temporal summation.
MTS is calculated as the increase in pain intensity rating (Δ change score) between the first stimulus and the end of the series.
|
Baseline, 1 month after Baseline
|
|
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)
Ramy czasowe: Baseline, 1 month after Baseline
|
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM).
CPM was assessed as the change in PPT on the trapezius immediately after the immersion of the contralateral hand up to the wrist in a cold-water bath (Neslab, Portsmouth, NH) at 4 degrees Celsius for 20 seconds.
[ [To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm^2) per second to the participant's trapezius.
Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).]
|
Baseline, 1 month after Baseline
|
|
Functional Connectivity Changes in Salience Network - Basal Ganglia Network (SAL-BGN) as Assessed by fMRI Neuroimaging
Ramy czasowe: Baseline
|
Functional Magnetic Resonance Imaging (fMRI) will be used to assess changes in functional connectivity between the Salience Network and Basal Ganglia Network (SAL-BGN) from baseline to post-intervention (1 month after baseline).
Functional connectivity is calculated based on the correlations in Blood Oxygen Level Dependent (BOLD) signal fluctuations in different brain regions.
Connectivity strength will be quantified using Fisher z-transformed correlation coefficients, with higher values indicating stronger functional connectivity.
|
Baseline
|
|
Functional Connectivity Changes in Language Network - Basal Ganglia Network (LAN-BGN) as Assessed by fMRI Neuroimaging
Ramy czasowe: Baseline, 1 month after Baseline
|
Functional Magnetic Resonance Imaging (fMRI) will be used to assess changes in functional connectivity between the Salience Network and Basal Ganglia Network (SAL-BGN) from baseline to post-intervention (1 month after baseline).
Functional connectivity is calculated based on the correlations in Blood Oxygen Level Dependent (BOLD) signal fluctuations in different brain regions.
Connectivity strength will be quantified using Fisher z-transformed correlation coefficients, with higher values indicating stronger functional connectivity.
|
Baseline, 1 month after Baseline
|
|
The Grooved Pegboard Test-Dominant Hand
Ramy czasowe: Baseline, 1 month after baseline
|
The Grooved Pegboard Test assesses fine motor skills, speed, and visual-motor coordination.
Participants are asked to place 25 pegs into slots as quickly as possible.
The total time to complete the task is recorded in seconds with dominant hand.
Higher times indicate slower performance and reduced dexterity
|
Baseline, 1 month after baseline
|
|
The Grooved Pegboard Test-Non Dominant Hand
Ramy czasowe: Baseline, 1 month after Baseline
|
The Grooved Pegboard Test assesses fine motor skills, speed, and visual-motor coordination.
Participants are asked to place 25 pegs into slots as quickly as possible.
The total time to complete the task is recorded in seconds with non-dominant hand.
Higher times indicate slower performance and reduced dexterity
|
Baseline, 1 month after Baseline
|
|
Interleukin-1 Alpha Level (From Plasma)
Ramy czasowe: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-1 Beta Level (From Plasma)
Ramy czasowe: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-2 Level (From Plasma)
Ramy czasowe: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-4 Level (From Plasma)
Ramy czasowe: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-6 Level (From Plasma)
Ramy czasowe: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-8 Level (From Plasma)
Ramy czasowe: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-10 Level (From Plasma)
Ramy czasowe: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-12 Level (p40) (From Plasma)
Ramy czasowe: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-12 Level (p70)-(From Plasma)
Ramy czasowe: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-13 Level (From Plasma)
Ramy czasowe: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-17 Level (From Plasma)
Ramy czasowe: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interferon-gamma Level (From Plasma)
Ramy czasowe: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Tumor Necrosis Factor-alpha Level (From Plasma)
Ramy czasowe: Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline
|
|
Tumor Necrosis Factor-alpha Level (From Plasma)
Ramy czasowe: 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
1 month after baseline
|
|
Transforming Growth Factor-beta Level 1(From Plasma)
Ramy czasowe: Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline
|
|
Transforming Growth Factor-beta Level 1 (From Plasma)
Ramy czasowe: 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
1 month after baseline
|
|
Calcitonin Gene-related Peptide Level(From Plasma)
Ramy czasowe: Baseline, 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after baseline
|
|
Monocyte Chemoattractant Protein-1 Level (From Plasma)
Ramy czasowe: Baseline, 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after baseline
|
|
Eotaxin Level (From Plasma)
Ramy czasowe: Baseline, 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after baseline
|
|
C-reactive Protein Level (From Plasma)
Ramy czasowe: Baseline, 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after baseline
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Nada Lukkahatai, PHD, MSN, RN, Johns Hopkins University
- Główny śledczy: Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN, The University of Texas Health Science Center, Houston
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.
- Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.
- Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.
- Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
- Vickers AJ, Vertosick EA, Lewith G, MacPherson H, Foster NE, Sherman KJ, Irnich D, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis. J Pain. 2018 May;19(5):455-474. doi: 10.1016/j.jpain.2017.11.005. Epub 2017 Dec 2.
- Shrout PE, Bolger N. Mediation in experimental and nonexperimental studies: new procedures and recommendations. Psychol Methods. 2002 Dec;7(4):422-45.
- Verbeke G, Molenberghs G. Linear Mixed Models for Longitudinal Data. Springer Science & Business Media; 2009.
- Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012 Oct 22;172(19):1444-53. doi: 10.1001/archinternmed.2012.3654.
- Vickers AJ, Cronin AM, Maschino AC, Lewith G, Macpherson H, Victor N, Sherman KJ, Witt C, Linde K; Acupuncture Trialists' Collaboration. Individual patient data meta-analysis of acupuncture for chronic pain: protocol of the Acupuncture Trialists' Collaboration. Trials. 2010 Sep 28;11:90. doi: 10.1186/1745-6215-11-90.
- Rao RD, Michalak JC, Sloan JA, Loprinzi CL, Soori GS, Nikcevich DA, Warner DO, Novotny P, Kutteh LA, Wong GY; North Central Cancer Treatment Group. Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3). Cancer. 2007 Nov 1;110(9):2110-8. doi: 10.1002/cncr.23008.
- Hershman DL, Lacchetti C, Dworkin RH, Lavoie Smith EM, Bleeker J, Cavaletti G, Chauhan C, Gavin P, Lavino A, Lustberg MB, Paice J, Schneider B, Smith ML, Smith T, Terstriep S, Wagner-Johnston N, Bak K, Loprinzi CL; American Society of Clinical Oncology. Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014 Jun 20;32(18):1941-67. doi: 10.1200/JCO.2013.54.0914. Epub 2014 Apr 14.
- Winters-Stone KM, Horak F, Jacobs PG, Trubowitz P, Dieckmann NF, Stoyles S, Faithfull S. Falls, Functioning, and Disability Among Women With Persistent Symptoms of Chemotherapy-Induced Peripheral Neuropathy. J Clin Oncol. 2017 Aug 10;35(23):2604-2612. doi: 10.1200/JCO.2016.71.3552. Epub 2017 Jun 6.
- Franconi G, Manni L, Schroder S, Marchetti P, Robinson N. A systematic review of experimental and clinical acupuncture in chemotherapy-induced peripheral neuropathy. Evid Based Complement Alternat Med. 2013;2013:516916. doi: 10.1155/2013/516916. Epub 2013 Jul 24.
- Flatters SJL, Bennett GJ. Studies of peripheral sensory nerves in paclitaxel-induced painful peripheral neuropathy: evidence for mitochondrial dysfunction. Pain. 2006 Jun;122(3):245-257. doi: 10.1016/j.pain.2006.01.037. Epub 2006 Mar 13.
- Asher GN, Jonas DE, Coeytaux RR, Reilly AC, Loh YL, Motsinger-Reif AA, Winham SJ. Auriculotherapy for pain management: a systematic review and meta-analysis of randomized controlled trials. J Altern Complement Med. 2010 Oct;16(10):1097-108. doi: 10.1089/acm.2009.0451.
- Smith EM, Pang H, Cirrincione C, Fleishman S, Paskett ED, Ahles T, Bressler LR, Fadul CE, Knox C, Le-Lindqwister N, Gilman PB, Shapiro CL; Alliance for Clinical Trials in Oncology. Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial. JAMA. 2013 Apr 3;309(13):1359-67. doi: 10.1001/jama.2013.2813.
- Miaskowski C, Mastick J, Paul SM, Abrams G, Cheung S, Sabes JH, Kober KM, Schumacher M, Conley YP, Topp K, Smoot B, Mausisa G, Mazor M, Wallhagen M, Levine JD. Impact of chemotherapy-induced neurotoxicities on adult cancer survivors' symptom burden and quality of life. J Cancer Surviv. 2018 Apr;12(2):234-245. doi: 10.1007/s11764-017-0662-8. Epub 2017 Nov 20.
- Yeh CH, Chiang YC, Hoffman SL, Liang Z, Klem ML, Tam WW, Chien LC, Suen LK. Efficacy of auricular therapy for pain management: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2014;2014:934670. doi: 10.1155/2014/934670. Epub 2014 Jul 23.
- Chen X, Spaeth RB, Freeman SG, Scarborough DM, Hashmi JA, Wey HY, Egorova N, Vangel M, Mao J, Wasan AD, Edwards RR, Gollub RL, Kong J. The modulation effect of longitudinal acupuncture on resting state functional connectivity in knee osteoarthritis patients. Mol Pain. 2015 Oct 29;11:67. doi: 10.1186/s12990-015-0071-9.
- Costigan M, Scholz J, Woolf CJ. Neuropathic pain: a maladaptive response of the nervous system to damage. Annu Rev Neurosci. 2009;32:1-32. doi: 10.1146/annurev.neuro.051508.135531.
- Keller M, Mazuch J, Abraham U, Eom GD, Herzog ED, Volk HD, Kramer A, Maier B. A circadian clock in macrophages controls inflammatory immune responses. Proc Natl Acad Sci U S A. 2009 Dec 15;106(50):21407-12. doi: 10.1073/pnas.0906361106. Epub 2009 Dec 1.
- Shimozuma K, Ohashi Y, Takeuchi A, Aranishi T, Morita S, Kuroi K, Ohsumi S, Makino H, Mukai H, Katsumata N, Sunada Y, Watanabe T, Hausheer FH. Feasibility and validity of the Patient Neurotoxicity Questionnaire during taxane chemotherapy in a phase III randomized trial in patients with breast cancer: N-SAS BC 02. Support Care Cancer. 2009 Dec;17(12):1483-91. doi: 10.1007/s00520-009-0613-7. Epub 2009 Mar 28.
- Pike CT, Birnbaum HG, Muehlenbein CE, Pohl GM, Natale RB. Healthcare costs and workloss burden of patients with chemotherapy-associated peripheral neuropathy in breast, ovarian, head and neck, and nonsmall cell lung cancer. Chemother Res Pract. 2012;2012:913848. doi: 10.1155/2012/913848. Epub 2012 Mar 14.
- Lin WC, Burke L, Schlenk EA, Yeh CH. Use of an Ecological Momentary Assessment Application to Assess the Effects of Auricular Point Acupressure for Chronic Low Back Pain. Comput Inform Nurs. 2019 May;37(5):276-282. doi: 10.1097/CIN.0000000000000478.
- Staff NP, Grisold A, Grisold W, Windebank AJ. Chemotherapy-induced peripheral neuropathy: A current review. Ann Neurol. 2017 Jun;81(6):772-781. doi: 10.1002/ana.24951. Epub 2017 Jun 5.
- Shah A, Hoffman EM, Mauermann ML, Loprinzi CL, Windebank AJ, Klein CJ, Staff NP. Incidence and disease burden of chemotherapy-induced peripheral neuropathy in a population-based cohort. J Neurol Neurosurg Psychiatry. 2018 Jun;89(6):636-641. doi: 10.1136/jnnp-2017-317215. Epub 2018 Feb 8.
- Park SB. Chemotherapy-induced peripheral neuropathy: highlighting unmet needs. J Neurol Neurosurg Psychiatry. 2018 Jun;89(6):558. doi: 10.1136/jnnp-2017-317528. Epub 2018 Feb 20. No abstract available.
- Kleckner IR, Kamen C, Gewandter JS, Mohile NA, Heckler CE, Culakova E, Fung C, Janelsins MC, Asare M, Lin PJ, Reddy PS, Giguere J, Berenberg J, Kesler SR, Mustian KM. Effects of exercise during chemotherapy on chemotherapy-induced peripheral neuropathy: a multicenter, randomized controlled trial. Support Care Cancer. 2018 Apr;26(4):1019-1028. doi: 10.1007/s00520-017-4013-0. Epub 2017 Dec 14.
- Gilron I, Bailey JM, Tu D, Holden RR, Weaver DF, Houlden RL. Morphine, gabapentin, or their combination for neuropathic pain. N Engl J Med. 2005 Mar 31;352(13):1324-34. doi: 10.1056/NEJMoa042580.
- Gilron I, Tu D, Holden RR, Jackson AC, DuMerton-Shore D. Combination of morphine with nortriptyline for neuropathic pain. Pain. 2015 Aug;156(8):1440-1448. doi: 10.1097/j.pain.0000000000000149.
- Yeh CH, Lukkahatai N, Campbell C, Sair H, Zhang F, Mensah S, Garry C, Zeng J, Chen C, Pinedo M, Khoshnoodi M, Smith TJ, Saligan LN. Preliminary Effectiveness of Auricular Point Acupressure on Chemotherapy-Induced Neuropathy: Part 1 Self-Reported Outcomes. Pain Manag Nurs. 2019 Dec;20(6):614-622. doi: 10.1016/j.pmn.2019.04.005. Epub 2019 May 30.
- Yeh CH, Lin WC, Kwai-Ping Suen L, Park NJ, Wood LJ, van Londen GJ, Howard Bovbjerg D. Auricular Point Acupressure to Manage Aromatase Inhibitor-Induced Arthralgia in Postmenopausal Breast Cancer Survivors: A Pilot Study. Oncol Nurs Forum. 2017 Jul 1;44(4):476-487. doi: 10.1188/17.ONF.476-487.
- Yeh CH, Kwai-Ping Suen L, Chien LC, Margolis L, Liang Z, Glick RM, Morone NE. Day-to-Day Changes of Auricular Point Acupressure to Manage Chronic Low Back Pain: A 29-day Randomized Controlled Study. Pain Med. 2015 Oct;16(10):1857-69. doi: 10.1111/pme.12789. Epub 2015 May 19.
- Yeh CH, Morone NE, Chien LC, Cao Y, Lu H, Shen J, Margolis L, Bhatnagar S, Hoffman S, Liang Z, Glick RM, Suen LK. Auricular point acupressure to manage chronic low back pain in older adults: a randomized controlled pilot study. Evid Based Complement Alternat Med. 2014;2014:375173. doi: 10.1155/2014/375173. Epub 2014 Jul 24.
- Yeh CH, Chien LC, Balaban D, Sponberg R, Primavera J, Morone NE, Glick R, Albers KM, Cohen SM, Ren D, Huang LC, Suen LK. A randomized clinical trial of auricular point acupressure for chronic low back pain: a feasibility study. Evid Based Complement Alternat Med. 2013;2013:196978. doi: 10.1155/2013/196978. Epub 2013 Feb 28.
- Yeh CH, Chien LC, Chiang YC, Huang LC. Auricular point acupressure for chronic low back pain: a feasibility study for 1-week treatment. Evid Based Complement Alternat Med. 2012;2012:383257. doi: 10.1155/2012/383257. Epub 2012 Jul 1.
- Yeh CH, Chien LC, Chiang YC, Ren D, Suen LK. Auricular point acupressure as an adjunct analgesic treatment for cancer patients: a feasibility study. Pain Manag Nurs. 2015 Jun;16(3):285-93. doi: 10.1016/j.pmn.2014.08.005. Epub 2014 Oct 31.
- Yeh CH, Chien LC, Lin WC, Bovbjerg DH, van Londen GJ. Pilot Randomized Controlled Trial of Auricular Point Acupressure to Manage Symptom Clusters of Pain, Fatigue, and Disturbed Sleep in Breast Cancer Patients. Cancer Nurs. 2016 Sep-Oct;39(5):402-10. doi: 10.1097/NCC.0000000000000303.
- Yeh CH, Lukkahatai N, Campbell C, Sair H, Zhang F, Mensah S, Garry C, Zeng J, Chen C, Pinedo M, Khoshnoodi M, Perrin N, Smith TJ, Saligan LN. Preliminary Effectiveness of Auricular Point Acupressure on Chemotherapy-Induced Neuropathy: Part 2 Laboratory-Assessed and Objective Outcomes. Pain Manag Nurs. 2019 Dec;20(6):623-632. doi: 10.1016/j.pmn.2019.04.004. Epub 2019 Jun 14.
- Sisignano M, Baron R, Scholich K, Geisslinger G. Mechanism-based treatment for chemotherapy-induced peripheral neuropathic pain. Nat Rev Neurol. 2014 Dec;10(12):694-707. doi: 10.1038/nrneurol.2014.211. Epub 2014 Nov 4.
- Smith EM, Bridges CM, Kanzawa G, Knoerl R, Kelly JP 4th, Berezovsky A, Woo C. Cancer treatment-related neuropathic pain syndromes--epidemiology and treatment: an update. Curr Pain Headache Rep. 2014 Nov;18(11):459. doi: 10.1007/s11916-014-0459-7.
- Janes K, Esposito E, Doyle T, Cuzzocrea S, Tosh DK, Jacobson KA, Salvemini D. A3 adenosine receptor agonist prevents the development of paclitaxel-induced neuropathic pain by modulating spinal glial-restricted redox-dependent signaling pathways. Pain. 2014 Dec;155(12):2560-2567. doi: 10.1016/j.pain.2014.09.016. Epub 2014 Sep 19.
- Peters CM, Jimenez-Andrade JM, Kuskowski MA, Ghilardi JR, Mantyh PW. An evolving cellular pathology occurs in dorsal root ganglia, peripheral nerve and spinal cord following intravenous administration of paclitaxel in the rat. Brain Res. 2007 Sep 7;1168:46-59. doi: 10.1016/j.brainres.2007.06.066. Epub 2007 Jul 17.
- Ji XT, Qian NS, Zhang T, Li JM, Li XK, Wang P, Zhao DS, Huang G, Zhang L, Fei Z, Jia D, Niu L. Spinal astrocytic activation contributes to mechanical allodynia in a rat chemotherapy-induced neuropathic pain model. PLoS One. 2013 Apr 9;8(4):e60733. doi: 10.1371/journal.pone.0060733. Print 2013.
- Tsavaris N, Kopterides P, Kosmas C, Efthymiou A, Skopelitis H, Dimitrakopoulos A, Pagouni E, Pikazis D, Zis PV, Koufos C. Gabapentin monotherapy for the treatment of chemotherapy-induced neuropathic pain: a pilot study. Pain Med. 2008 Nov;9(8):1209-16. doi: 10.1111/j.1526-4637.2007.00325.x.
- Magnowska M, Izycka N, Kapola-Czyz J, Romala A, Lorek J, Spaczynski M, Nowak-Markwitz E. Effectiveness of gabapentin pharmacotherapy in chemotherapy-induced peripheral neuropathy. Ginekol Pol. 2018;89(4):200-4. doi: 10.5603/GP.a2018.0034.
- Bellingham GA, Peng PW. Duloxetine: a review of its pharmacology and use in chronic pain management. Reg Anesth Pain Med. 2010 May-Jun;35(3):294-303. doi: 10.1097/AAP.0b013e3181df2645.
- Irwin ML, Cartmel B, Gross CP, Ercolano E, Li F, Yao X, Fiellin M, Capozza S, Rothbard M, Zhou Y, Harrigan M, Sanft T, Schmitz K, Neogi T, Hershman D, Ligibel J. Randomized exercise trial of aromatase inhibitor-induced arthralgia in breast cancer survivors. J Clin Oncol. 2015 Apr 1;33(10):1104-11. doi: 10.1200/JCO.2014.57.1547. Epub 2014 Dec 1.
- Lu W, Giobbie-Hurder A, Freedman RA, Shin IH, Lin NU, Partridge AH, Rosenthal DS, Ligibel JA. Acupuncture for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Survivors: A Randomized Controlled Pilot Trial. Oncologist. 2020 Apr;25(4):310-318. doi: 10.1634/theoncologist.2019-0489. Epub 2019 Oct 14.
- Li K, Giustini D, Seely D. A systematic review of acupuncture for chemotherapy-induced peripheral neuropathy. Curr Oncol. 2019 Apr;26(2):e147-e154. doi: 10.3747/co.26.4261. Epub 2019 Apr 1.
- Smith TJ, Razzak AR, Blackford AL, Ensminger J, Saiki C, Longo-Schoberlein D, Loprinzi CL. A Pilot Randomized Sham-Controlled Trial of MC5-A Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN). J Palliat Care. 2020 Jan;35(1):53-58. doi: 10.1177/0825859719827589. Epub 2019 Feb 3.
- Pachman DR, Weisbrod BL, Seisler DK, Barton DL, Fee-Schroeder KC, Smith TJ, Lachance DH, Liu H, Shelerud RA, Cheville AL, Loprinzi CL. Pilot evaluation of Scrambler therapy for the treatment of chemotherapy-induced peripheral neuropathy. Support Care Cancer. 2015 Apr;23(4):943-51. doi: 10.1007/s00520-014-2424-8. Epub 2014 Sep 24.
- Gewandter JS, Chaudari J, Ibegbu C, Kitt R, Serventi J, Burke J, Culakova E, Kolb N, Sluka KA, Tejani MA, Mohile NA. Wireless transcutaneous electrical nerve stimulation device for chemotherapy-induced peripheral neuropathy: an open-label feasibility study. Support Care Cancer. 2019 May;27(5):1765-1774. doi: 10.1007/s00520-018-4424-6. Epub 2018 Aug 27.
- Galantino ML, Brooks J, Tiger R, Jang S, Wilson K. Effectiveness of Somatic Yoga and Meditation: A Pilot Study in a Multicultural Cancer Survivor Population with Chemotherapy-Induced Peripheral Neuropathy. Int J Yoga Therap. 2020 Jan 1;30(1):49-61. doi: 10.17761/2020-D-18-00030.
- Kono T, Mamiya N, Chisato N, Ebisawa Y, Yamazaki H, Watari J, Yamamoto Y, Suzuki S, Asama T, Kamiya K. Efficacy of goshajinkigan for peripheral neurotoxicity of oxaliplatin in patients with advanced or recurrent colorectal cancer. Evid Based Complement Alternat Med. 2011;2011:418481. doi: 10.1093/ecam/nep200. Epub 2011 Jan 11.
- Li Y, Cui HJ, Huang JC, Wu XQ. Clinical study of Jiawei Huangqi Guizhi Wuwu Decoction in preventing and treating peripheral neuro-sensory toxicity caused by oxaliplatin. Chin J Integr Med. 2006 Mar;12(1):19-23. doi: 10.1007/BF02857424.
- Liu Y, May BH, Zhang AL, Guo X, Lu C, Xue CC, Zhang H. Integrative Herbal Medicine for Chemotherapy-Induced Peripheral Neuropathy and Hand-Foot Syndrome in Colorectal Cancer: A Systematic Review and Meta-Analysis. Integr Cancer Ther. 2019 Jan-Dec;18:1534735418817833. doi: 10.1177/1534735418817833. Epub 2018 Dec 10.
- Tofthagen C, Gonzalez L, Visovsky C, Akers A. Self-management of oxaliplatin-related peripheral neuropathy in colorectal cancer survivors. Chemother Res Pract. 2013;2013:547932. doi: 10.1155/2013/547932. Epub 2013 Aug 25.
- Molsberger AF, Schneider T, Gotthardt H, Drabik A. German Randomized Acupuncture Trial for chronic shoulder pain (GRASP) - a pragmatic, controlled, patient-blinded, multi-centre trial in an outpatient care environment. Pain. 2010 Oct;151(1):146-154. doi: 10.1016/j.pain.2010.06.036. Epub 2010 Jul 23.
- Nahin RL, Barnes PM, Stussman BJ. Insurance Coverage for Complementary Health Approaches Among Adult Users: United States, 2002 and 2012. NCHS Data Brief. 2016 Jan;(235):1-8.
- Schapira MM, Mackenzie ER, Lam R, Casarett D, Seluzicki CM, Barg FK, Mao JJ. Breast cancer survivors willingness to participate in an acupuncture clinical trial: a qualitative study. Support Care Cancer. 2014 May;22(5):1207-15. doi: 10.1007/s00520-013-2073-3. Epub 2013 Dec 21.
- Nogier P. Handbook to auriculotherapy. 1st ed. Moulins-les-Metz: Maisonneuve; 1981.
- Nogier R. How did Paul Nogier establish the map of the ear? Medical Acupuncture. 2014;26(2):76-83.
- Nogier P. Points Reflexes Auricularis. Maisonneuve SA: Moulin Les-Metz, France; 1987.
- Yeh CH, Huang LC. Comprehensive and systematic auricular diagnosis protocol. Medical Acupuncture 2013;25(6):423-436.
- Oleson T. Auriculotherapy Manual: Chinese and Western Systems of Ear Acupuncture. 4th ed. Edinburgh: Churchill Livingstone, Elsevier; 2014.
- Huang LC. Auricular Medicine: A Complete Manual of Auricular Diagnosis and Treatment. 1st ed. Orlando Florida: Auricular International Research & Training; 2005.
- Alimi D, Geissmann A, Gardeur D. Auricular acupuncture stimulation measured on functional magnetic resonance imaging. Medical Acupuncture. 2002;13(2):18-21.
- Romoli M, Allais G, Airola G, Benedetto C, Mana O, Giacobbe M, Pugliese AM, Battistella G, Fornari E. Ear acupuncture and fMRI: a pilot study for assessing the specificity of auricular points. Neurol Sci. 2014 May;35 Suppl 1:189-93. doi: 10.1007/s10072-014-1768-7.
- Fonken LK, Frank MG, Kitt MM, Barrientos RM, Watkins LR, Maier SF. Microglia inflammatory responses are controlled by an intrinsic circadian clock. Brain Behav Immun. 2015 Mar;45:171-9. doi: 10.1016/j.bbi.2014.11.009. Epub 2014 Nov 26.
- Lundeberg T, Lund I. Acupuncture for preconditioning of expectancy and/or Pavlovian extinction. Acupunct Med. 2008 Dec;26(4):234-8. doi: 10.1136/aim.26.4.234.
- Lundeberg T, Lund I, Naslund J. Acupuncture--self-appraisal and the reward system. Acupunct Med. 2007 Sep;25(3):87-99. doi: 10.1136/aim.25.3.87.
- Furlan AD, Yazdi F, Tsertsvadze A, Gross A, Van Tulder M, Santaguida L, Gagnier J, Ammendolia C, Dryden T, Doucette S, Skidmore B, Daniel R, Ostermann T, Tsouros S. A systematic review and meta-analysis of efficacy, cost-effectiveness, and safety of selected complementary and alternative medicine for neck and low-back pain. Evid Based Complement Alternat Med. 2012;2012:953139. doi: 10.1155/2012/953139. Epub 2011 Nov 24.
- Hsu C, Sherman KJ, Eaves ER, Turner JA, Cherkin DC, Cromp D, Schafer L, Ritenbaugh C. New perspectives on patient expectations of treatment outcomes: results from qualitative interviews with patients seeking complementary and alternative medicine treatments for chronic low back pain. BMC Complement Altern Med. 2014 Jul 30;14:276. doi: 10.1186/1472-6882-14-276.
- Schafer LM, Hsu C, Eaves ER, Ritenbaugh C, Turner J, Cherkin DC, Sims C, Sherman KJ. Complementary and alternative medicine (CAM) providers' views of chronic low back pain patients' expectations of CAM therapies: a qualitative study. BMC Complement Altern Med. 2012 Nov 27;12:234. doi: 10.1186/1472-6882-12-234.
- Schnur JB, Hallquist MN, Bovbjerg DH, Silverstein JH, Stojceska A, Montgomery GH. Predictors of expectancies for post-surgical pain and fatigue in breast cancer surgical patients. Pers Individ Dif. 2007;42(3):419-429. doi: 10.1016/j.paid.2006.07.009.
- Lind BK, Lafferty WE, Tyree PT, Sherman KJ, Deyo RA, Cherkin DC. The role of alternative medical providers for the outpatient treatment of insured patients with back pain. Spine (Phila Pa 1976). 2005 Jun 15;30(12):1454-9. doi: 10.1097/01.brs.0000166527.18442.10.
- Shelton RC, Clarke Hillyer G, Hershman DL, Leoce N, Bovbjerg DH, Mandelblatt JS, Kushi LH, Lamerato L, Nathanson SD, Ambrosone CB, Neugut AI. Interpersonal influences and attitudes about adjuvant therapy treatment decisions among non-metastatic breast cancer patients: an examination of differences by age and race/ethnicity in the BQUAL study. Breast Cancer Res Treat. 2013 Feb;137(3):817-28. doi: 10.1007/s10549-012-2370-4. Epub 2012 Dec 22.
- Craig BM, Reeve BB, Brown PM, Cella D, Hays RD, Lipscomb J, Simon Pickard A, Revicki DA. US valuation of health outcomes measured using the PROMIS-29. Value Health. 2014 Dec;17(8):846-53. doi: 10.1016/j.jval.2014.09.005.
- PROMIS-29 Profile v2. http://www.assessmentcenter.net/documents/InstrumentLibrary.pdf. Accessed July 31, 2015.
- (CMS) CfMMS. The 2019 Rate Announcement and Call Letter:and selecting "2019 Announcement.". 2018; https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Announcements-and-Documents.html Accessed May 24, 2018.
- Campbell CM, Carroll CP, Kiley K, Han D, Haywood C Jr, Lanzkron S, Swedberg L, Edwards RR, Page GG, Haythornthwaite JA. Quantitative sensory testing and pain-evoked cytokine reactivity: comparison of patients with sickle cell disease to healthy matched controls. Pain. 2016 Apr;157(4):949-956. doi: 10.1097/j.pain.0000000000000473.
- Yoo SS, Teh EK, Blinder RA, Jolesz FA. Modulation of cerebellar activities by acupuncture stimulation: evidence from fMRI study. Neuroimage. 2004 Jun;22(2):932-40. doi: 10.1016/j.neuroimage.2004.02.017.
- Yeh CH, Chien LC, Albers KM, et al. Function of auricular point acupressure in inducing changes in inflammatory cytokines during chronic low back pain: A pilot study. Medical Acupuncture. 2014;26(1):31-39.
- Agresti A. Categorical Data Analysis. 2nd ed. New Jersey: John Wiley & Sons Inc.; 2002.
- Xiang L, Tse SK, Lee AH. Influence diagnostics for generalized linear mixed models: applications to clustered data. Computational Statistics & Data Analysis. 2002;40(4):759-774.
- Birhanu T, Molenberghs G, Sotto C, Kenward MG. Doubly robust and multiple-imputation-based generalized estimating equations. J Biopharm Stat. 2011 Mar;21(2):202-25. doi: 10.1080/10543406.2011.550096.
- Zeger SL, Liang KY, Albert PS. Models for longitudinal data: a generalized estimating equation approach. Biometrics. 1988 Dec;44(4):1049-60.
- Lukkahatai N, Nguyen MV, Zhang J, Cho YM, Benjasirisan C, Jia HM, Campbell CM, Kawi J, Wu H, Wang H, Bora R, Thrul J, Johnson CM, Smith TJ. A randomized controlled study of auricular point acupressure to manage chemotherapy-induced neuropathy: Study protocol. PLoS One. 2024 Sep 26;19(9):e0311135. doi: 10.1371/journal.pone.0311135. eCollection 2024.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
8 lipca 2021
Zakończenie podstawowe (Rzeczywisty)
30 maja 2025
Ukończenie studiów (Rzeczywisty)
19 marca 2026
Daty rejestracji na studia
Pierwszy przesłany
3 czerwca 2021
Pierwszy przesłany, który spełnia kryteria kontroli jakości
3 czerwca 2021
Pierwszy wysłany (Rzeczywisty)
9 czerwca 2021
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
4 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
9 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- HSC-SN-21-1085
- 1R01CA245054-01A1 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .