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Are Supervised Exercises and TENS Necessary Along With Prescribed Home Exercises for Chronic Low Back Pain?

28 marca 2022 zaktualizowane przez: Saurab Sharma, Kathmandu University School of Medical Sciences

Effectiveness of TENS and Supervised Motor Control Exercises Compared To Unsupervised Exercises in Subjects With Chronic Low Back Pain: A Randomized Clinical Trial

The purpose of this study is to compare the added effects of TENS and Supervised Motor Control Exercises (SMCE) over Unsupervised Home Exercise Program (UHEP) on disability, pain and other outcomes.

Przegląd badań

Status

Wycofane

Warunki

Interwencja / Leczenie

Szczegółowy opis

Chronic low back pain (CLBP) is a common problem causing disability and high economic burden in globally as well as in Nepal. There is no consensus on treatment of CLBP, however motor control exercises have good evidence on improvement in pain and disability in CLBP population, whereas transcutaneous electrical nerve stimulation (TENS) is a common treatment of choice with some evidence. But, we do not know if supervising these motor control exercises (SMCE) and TENS have any added benefit over home exercise program (HEP) which is commonly prescribed mode of exercises. We plan to conduct a three armed randomized control trial to answer this question to compare effects of SMCE, TENS and HEP versus SMCE and HEP versus HEP alone on disability and pain at two weeks and six months follow up. Three way-mixed model analysis of Variance (ANOVA) will be used as the statistical test. Appropriate post hoc analysis will be done to compare within group and between group differences.

Typ studiów

Interwencyjne

Faza

  • Nie dotyczy

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 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  1. Nonspecific Low back pain for more than 3 months with pain primarily localized between T12 and gluteal folds, if patients report that their pain is provoked and relieved with postures, movement and activities.
  2. Age between 18 to 65 years
  3. Male or female
  4. All educational backgrounds (educated or uneducated)
  5. Pain intensity more than 2/10 on NPRS and
  6. Disability of more than 20/100 on NODI

Exclusion Criteria:

  1. Red flags noted in the participant's general medical screening questionnaire (i.e. tumor, metabolic diseases, Rheumatoid Arthritis, osteoporosis, prolonged history of steroid use, etc.)

  2. Signs consistent with nerve root compression, this includes any one of the following:

    1. Reproduction of low back or leg pain with straight leg raise at less than 45 degrees
    2. Muscle weakness involving a major muscle group of the lower extremity
    3. Diminished lower extremity muscle stretch reflex (Quadriceps or Achilles tendon)
    4. Diminished or absent sensation to pinprick in any lower extremity dermatome
  3. Prior surgery to the lumbar spine or buttock
  4. Current pregnancy
  5. Past medical history of osteoporosis or spinal compression fracture

  6. Participants who do not provide informed consent for the study

    -

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: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: TENS
Participants will receive Active-TENS along with SMCE and UHEP. Six treatment sessions will be given over two weeks. Total duration of the treatment session may last from 40 - 60 minutes.
Urządzenie: TENS

Six treatment sessions will be given over two weeks. Total duration of the treatment session may last from 40 - 60 minutes.

  • Equipment- TENS (CEFAR Basic TENS Machine)
  • Electrodes- Four channel electrode to cover the site of pain
  • Site of electrode placement- will be decided by the physical therapist to best suit or cover the area of pain based on complaints of patient based on the body chart.
  • Intensity- the intensity will be increased progressively until maximum tolerable intensity is reached. This stimulation may cause visible muscle contraction. This type of current is also referred to as Motor-level TENS, which is effective for chronic pain. The intensity will not be increased beyond 25 milli Amperes if no sensation is perceived by the patient.
  • Frequency- 5 Hertz
  • Duration- 30 minutes
Inne nazwy:
  • przezskórna elektryczna stymulacja nerwów
  • przezskórna stymulacja elektryczna
  • transcutenous nerve stimulation
  • Low TENS
  • Motor level TENS
Inny: SMCE

Six sessions of supervised Motor control exercises will be provided over the period of two weeks. Exercises will be provided in order to target the function of core muscles of the spine. Each participant in the SMCE group will be trained by a physical therapist to recruit the deep muscles of the spine and reduce the activity of superficial muscles.

Initially participants will be taught how to contract the transversus abdominis and multifidus muscles in isolation from the more superficial trunk muscles, but in conjunction with the pelvic floor muscles. Pressure biofeedback will be used in order to provide feedback about muscle recruitment to the participant. Exercises will be provided to the participants in the progressive manner. Later, movement of limbs will be incorporated with the contraction of the core muscles. Finally, these core muscle activation will be emphasized during the functional activities.

Inne nazwy:
  • ćwiczenia stabilności rdzenia
  • spinal stabilization exercises
  • Supervised motor control exercises
Inny: UHEP

All the participants will receive the following treatments:

  1. Unsupervised home exercise program- which includes series of motor control exercises along with specific exercises including stretching exercises based on impairments.
  2. Education in terms of body mechanics, ergonomics advises and educational leaflet in the form of Nepali version of Back book which includes, evidence based advises about back pain self-management, advice to remain active. Treating physical therapist will educate all the participants in the first intervention session.
  3. Participants will not be asked to not take the "over the counter" analgesics including Acetaminophen or Non-inflammatory anti-inflammatory drugs (ibuprofen).
Inne nazwy:
  • home exercise program
  • Unsupervised home exercise program
Eksperymentalny: SMCE
Participants will receive SMCE and UHEP. Six sessions of supervised Motor control exercises will be provided over the period of two weeks.
Inny: SMCE

Six sessions of supervised Motor control exercises will be provided over the period of two weeks. Exercises will be provided in order to target the function of core muscles of the spine. Each participant in the SMCE group will be trained by a physical therapist to recruit the deep muscles of the spine and reduce the activity of superficial muscles.

Initially participants will be taught how to contract the transversus abdominis and multifidus muscles in isolation from the more superficial trunk muscles, but in conjunction with the pelvic floor muscles. Pressure biofeedback will be used in order to provide feedback about muscle recruitment to the participant. Exercises will be provided to the participants in the progressive manner. Later, movement of limbs will be incorporated with the contraction of the core muscles. Finally, these core muscle activation will be emphasized during the functional activities.

Inne nazwy:
  • ćwiczenia stabilności rdzenia
  • spinal stabilization exercises
  • Supervised motor control exercises
Inny: UHEP

All the participants will receive the following treatments:

  1. Unsupervised home exercise program- which includes series of motor control exercises along with specific exercises including stretching exercises based on impairments.
  2. Education in terms of body mechanics, ergonomics advises and educational leaflet in the form of Nepali version of Back book which includes, evidence based advises about back pain self-management, advice to remain active. Treating physical therapist will educate all the participants in the first intervention session.
  3. Participants will not be asked to not take the "over the counter" analgesics including Acetaminophen or Non-inflammatory anti-inflammatory drugs (ibuprofen).
Inne nazwy:
  • home exercise program
  • Unsupervised home exercise program
Aktywny komparator: UHEP
Unsupervised home exercise program will be prescribed with home exercise leaflet and education leaflet in the form of back book on first treatment session.
Inny: UHEP

All the participants will receive the following treatments:

  1. Unsupervised home exercise program- which includes series of motor control exercises along with specific exercises including stretching exercises based on impairments.
  2. Education in terms of body mechanics, ergonomics advises and educational leaflet in the form of Nepali version of Back book which includes, evidence based advises about back pain self-management, advice to remain active. Treating physical therapist will educate all the participants in the first intervention session.
  3. Participants will not be asked to not take the "over the counter" analgesics including Acetaminophen or Non-inflammatory anti-inflammatory drugs (ibuprofen).
Inne nazwy:
  • home exercise program
  • Unsupervised home exercise program

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Disability (Nepali version of Oswestry Disability Index (NODI)
Ramy czasowe: 2 weeks
Nepali version of Oswestry Disability Index (NODI) will be used to measure disability which is a cross culturally adapted and validated tool for measuring disability in low back pain population in Nepal. The tool has acceptable reliability (Cronbach's Alpha= 0.723, intraclass correlation coefficient= 0.875)
2 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Pain intensity (Numerical Pain Rating Scale (NPRS)
Ramy czasowe: 2 weeks
Numerical Pain Rating Scale (NPRS) - An 11-point numeric pain rating scale ranging from 0 (no pain) to 10 (worst imaginable pain) will be used to assess current pain intensity and the best and worst level of pain during the last 24 hours.
2 weeks
Pain intensity (Numerical Pain Rating Scale (NPRS)
Ramy czasowe: 6 months
Numerical Pain Rating Scale (NPRS) - An 11-point numeric pain rating scale ranging from 0 (no pain) to 10 (worst imaginable pain) will be used to assess current pain intensity and the best and worst level of pain during the last 24 hours.
6 months
Disability (Nepali version of Oswestry Disability Index (NODI)
Ramy czasowe: 6 months
Nepali version of Oswestry Disability Index (NODI) will be used to measure disability which is a cross culturally adapted and validated tool for measuring disability in low back pain population in Nepal. The tool has acceptable reliability (Cronbach's Alpha= 0.723, intraclass correlation coefficient= 0.875)
6 months

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Changes in pain and disability (Global Rating of Change (GROC)
Ramy czasowe: 2 weeks
Global Rating of Change (GROC) - The fifteen-point global rating scale will be used. The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Intermittent descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively. The global rating will be administered at the follow-up examinations only.
2 weeks
Changes in pain and disability (Global Rating of Change (GROC)
Ramy czasowe: 6 months
Using Global rating of change (GROC)
6 months
Need for medication (using frequency and dosage and types of analgesics used)
Ramy czasowe: 6 months
using frequency and dosage and types of analgesics used
6 months
Need for follow up (number of treatment sessions in past six months will be recorded)
Ramy czasowe: 6 months
number of treatment sessions in past six months will be recorded
6 months
Adverse events
Ramy czasowe: 6 months
numbers of adverse events are noted down using a questionnaire
6 months
Fear avoidance (Fear avoidance belief questionnaire (FABQ)
Ramy czasowe: 6 months
Fear avoidance belief questionnaire (FABQ) - The FABQ is a 16-item scale that assesses the influence of fear avoidance behaviors on physical and work activities. Each item is scored from 0-6 with possible scores ranging between 0-42 and higher scores representing increased fear-avoidance beliefs.
6 months
Pain Catastrophizing (Pain catastrophizing Scale (PCS)
Ramy czasowe: 6 months
Pain catastrophizing Scale (PCS) - Nepali translation of PCS is a 13-item scale that assesses the pain catastrophizing. Pain catastrophizing is an exaggerated, negative focus on pain and is related to psychological distress, pain severity, and other negative outcomes in pain population. Participants responded to each item using a Likert-type scale from 0 ('not at all') to 4 ('all the time').
6 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Kathmandu University School of Medical Sciences

Śledczy

  • Główny śledczy: Saurab Sharma, MPT, Kathmandu University School of Medical Sciences, Nepal

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 (Oczekiwany)

1 sierpnia 2019

Zakończenie podstawowe (Oczekiwany)

1 września 2020

Ukończenie studiów (Oczekiwany)

1 grudnia 2020

Daty rejestracji na studia

Pierwszy przesłany

15 stycznia 2015

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 stycznia 2015

Pierwszy wysłany (Oszacować)

22 stycznia 2015

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 kwietnia 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

28 marca 2022

Ostatnia weryfikacja

1 marca 2022

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • KUSMS107/14

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

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 .

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