Thoracic Spine Thrust Manipulation for Cervicogenic Headaches: A Randomized Clinical Trial
3 lutego 2021 zaktualizowane przez: University of Colorado, Denver
Headaches have been listed as 1 of the 10 most disabling conditions worldwide.
(Stovner et al., 2007) and cervicogenic headaches (CeHs) comprise 15% of the individuals with these complaints.
(Nillsson, 1995); (Fernandez de-las-penas et al., 2005) The current best approach to the conservative care of this condition has yet to be determined.
The primary aim of this study is to determine whether individuals with CeHs will respond to a program of thoracic spine thrust manipulation in isolation.
This may further the current body of evidence by offering an alternative, potentially safer approach to the conservative care of individuals with this condition.
Additionally, results of this study may serve to drive a larger scale Randomized Clinical Trial (RCT) by offering information regarding feasibility of recruitment of individuals with chronic CeHs as well as timing and dosing of the intervention.
Przegląd badań
Status
Zakończony
Warunki
Szczegółowy opis
Headaches have been listed as 1 of the 10 most disabling conditions worldwide.
(Stovner et al., 2007) and cervicogenic headaches (CeHs) comprise 15% of the individuals with these complaints.
(Nillsson, 1995); (Fernandez de-las-penas et al., 2005) The current best approach to the conservative care of this condition has yet to be determined.
Evidence suggests that manipulative therapy aimed at the cervical spine in combination with exercise is helpful in alleviating these symptoms.
(Jull et al., 2002) The risk of injury from cervical spine manipulative techniques has been documented to be remote (Haldeman et al., 2002; DiFabio 1999), however the potential consequences can be severe.
Therefore with inherently lower risks, thoracic spine manipulations may be a suitable alternative as the evidence is accumulating for its influence on the cervical spine.
(Mintken et al., 2010; Boyles et al., 2009; Cleland et al., 2005 & 2007 A & B, 2010; Flynn et al., 2001; Fernandez-de-las-penas et al., 2004; Piva et al., 2000; Browder et al., 2004) The primary aim of this study is to determine whether individuals with CeHs will respond to a program of thoracic spine thrust manipulation in isolation.
This may further the current body of evidence by offering an alternative, potentially safer approach to the conservative care of individuals with this condition.
Additionally, results of this study may serve to drive a larger scale RCT by offering information regarding feasibility of recruitment of individuals with chronic CeHs as well as timing and dosing of the intervention.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
48
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Colorado
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Aurora, Colorado, Stany Zjednoczone, 80045
- University of Colorado Anschutz Medical Campus
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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 do 60 lat (Dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Between 18 and 60 years old Sjaastad et al for CeH, which included
- unilateral or unilateral dominant side-consistent headache associated with neck pain and aggravated by neck postures or movement (Sjaastad et al., 1998)
- joint tenderness in at least one of the three upper cervical joints (C0-C3) as assessed by manual palpation
- headache frequency of at least one per week over the past 2 months
Exclusion Criteria:
- red flags noted in the patient's Neck Medical Screening Questionnaire (e.g. tumor, fracture)
- metabolic diseases RA, osteoporosis, prolonged history of steroid use, symptoms of vertebrobasilary insufficiency, pregnancy, cervical spinal stenosis, bilateral upper extremity symptoms etc.)
- history of whiplash injury within the past six weeks
- evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes
- two or more positive neurologic signs consistent with nerve root compression, including any two of the following: muscle weakness involving a major muscle group of the upper extremity, diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps reflex), diminished or absent sensation to pinprick in any upper extremity dermatome
- prior surgery to the neck or thoracic spine
- chiropractic or physical therapy treatment for their headaches over the past 6-months
- bilateral headache description
- migraine headaches with or without aura
- workers compensation or pending legal action regarding their headaches
- inability to comply with treatment and follow-up schedule
- we will not recruit individuals whom the researcher is in a position to punish or reward, whether through grades, evaluations, or promotions
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: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Treatment (thoracic manipulation)
Patients in the initial manipulation group will attend physical therapy two sessions per week for 3 weeks for a total of 6 sessions.
Each treatment session will last for a total of 15 minutes.
After the initial manipulation group receives 3 weeks of treatment they will wait for 1-week, be retested, and then crossover into the other group.
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Manipulation techniques will include: CT junction manipulation seated and supine, upper thoracic manipulation, middle thoracic spine manipulation in seated and supine, middle thoracic spine manipulation in prone, thoracic active range of motion exercise and instruction to maintain usual activity level within the limits of pain.
Inne nazwy:
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Aktywny komparator: Wait-list (thoracic manipulation)
When individuals are assigned to the wait-list control group they will serve as the control for 3 weeks while the initial manipulation group receives treatment.
After serving as the wait-list control condition for 3 weeks, this group will then return for testing and will receive the manipulation package as described below at 4 weeks.
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Manipulation techniques will include: CT junction manipulation seated and supine, upper thoracic manipulation, middle thoracic spine manipulation in seated and supine, middle thoracic spine manipulation in prone, thoracic active range of motion exercise and instruction to maintain usual activity level within the limits of pain.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Headache Disability Index
Ramy czasowe: Baseline
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Headache Disability Index (HDI): The HDI is a 25-item questionnaire used to assess the patient's perceived impact of the headaches on their daily life.
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Baseline
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Headache Disability Index
Ramy czasowe: 4 weeks
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Headache Disability Index (HDI): The HDI is a 25-item questionnaire used to assess the patient's perceived impact of the headaches on their daily life.
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4 weeks
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Headache Disability Index
Ramy czasowe: 8 weeks
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Headache Disability Index (HDI): The HDI is a 25-item questionnaire used to assess the patient's perceived impact of the headaches on their daily life.
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8 weeks
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Headache Disability Index
Ramy czasowe: 3 months
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Headache Disability Index (HDI): The HDI is a 25-item questionnaire used to assess the patient's perceived impact of the headaches on their daily life.
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3 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Numeric Pain Rating Scale
Ramy czasowe: Baseline
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An 11-point NPRS will be used to measure pain intensity.
Patients rate their current level of pain and their worse and least amount of pain in the last 24 hours.
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Baseline
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Numeric Pain Rating Scale
Ramy czasowe: 4 weeks
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An 11-point NPRS will be used to measure pain intensity.
Patients rate their current level of pain and their worse and least amount of pain in the last 24 hours.
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4 weeks
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Numeric Pain Rating Scale
Ramy czasowe: 8 weeks
|
An 11-point NPRS will be used to measure pain intensity.
Patients rate their current level of pain and their worse and least amount of pain in the last 24 hours.
|
8 weeks
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Numeric Pain Rating Scale
Ramy czasowe: 3 months
|
An 11-point NPRS will be used to measure pain intensity.
Patients rate their current level of pain and their worse and least amount of pain in the last 24 hours.
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3 months
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Pain Self Efficacy Questionnaire (PSEQ)
Ramy czasowe: Baseline
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The 10 item questionnaire is used to assess the patient's confidence in performing specific activities despite pain.
Items are listed on a 0 to 6 scale, with a maximum score of 60 points.
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Baseline
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Pain Self Efficacy Questionnaire (PSEQ)
Ramy czasowe: 4 weeks
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The 10 item questionnaire is used to assess the patient's confidence in performing specific activities despite pain.
Items are listed on a 0 to 6 scale, with a maximum score of 60 points.
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4 weeks
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Pain Self Efficacy Questionnaire (PSEQ)
Ramy czasowe: 8 weeks
|
The 10 item questionnaire is used to assess the patient's confidence in performing specific activities despite pain.
Items are listed on a 0 to 6 scale, with a maximum score of 60 points.
|
8 weeks
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Pain Self Efficacy Questionnaire (PSEQ)
Ramy czasowe: 3 months
|
The 10 item questionnaire is used to assess the patient's confidence in performing specific activities despite pain.
Items are listed on a 0 to 6 scale, with a maximum score of 60 points.
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3 months
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Amy W McDevitt, DPT, University of Colorado, Denver
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
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)
1 maja 2016
Zakończenie podstawowe (Rzeczywisty)
19 września 2019
Ukończenie studiów (Rzeczywisty)
19 września 2019
Daty rejestracji na studia
Pierwszy przesłany
10 marca 2016
Pierwszy przesłany, który spełnia kryteria kontroli jakości
10 marca 2016
Pierwszy wysłany (Oszacować)
15 marca 2016
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
4 lutego 2021
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
3 lutego 2021
Ostatnia weryfikacja
1 lutego 2021
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 15-0983
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
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