- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07694219
Bowen Therapy and McGill Stabilization Exercises in Chronic Low Back Pain
Comparison of Bowen Therapy and McGill Stabilization Exercises on Pain, Range of Motion, and Disability in Chronic Low Back Pain: A Randomized Controlled Trial
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
This is a single-center, parallel-group, randomized controlled trial conducted at Sehat Medical Complex. A total of 100 participants aged 25-55 years with chronic nonspecific low back pain of more than three months' duration will be randomly allocated to one of two treatment groups using a computer-generated randomization sequence.
Participants in the experimental group will receive Bowen Therapy combined with the McGill stabilization exercise program, while participants in the comparator group will receive Bowen Therapy alone. Both groups will receive standard physiotherapy modalities, including a 10-minute moist hot pack and transcutaneous electrical nerve stimulation (TENS) before each treatment session. The intervention period will last six weeks, with treatment sessions conducted three times per week.
Outcome assessments will be performed at baseline and at Weeks 2, 4, and 6. Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS), lumbar range of motion will be assessed using a bubble inclinometer, and functional disability will be evaluated using the Modified Oswestry Disability Index (MODI). All assessments will be performed by the same trained physiotherapist to ensure measurement consistency.
The study has been approved by the Institutional Review Board of Sehat Medical Complex (Approval No. IREB-UOL-SMC/001-26/2024) and will be conducted in accordance with the Declaration of Helsinki. Written informed consent will be obtained from all participants before enrollment. Statistical analysis will be performed using SPSS version 25.0. Descriptive statistics will summarize baseline characteristics, the Shapiro-Wilk test will assess data normality, and repeated-measures analysis of variance (RM-ANOVA) will be used to evaluate changes between groups over time. Statistical significance will be set at p < 0.05.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Lahore, Pakistan, 54590
- Sehat Medical Complex
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- With chronic localized low back pain lasting over three months
- Without any signs of pain below the gluteal fold
- Fulfills the recommended diagnostic criteria of nonspecific chronic low back pain.
Exclusion Criteria:
- Lumbar disc herniation
- Lumbar canal stenosis
- Spondylolisthesis
- Spondylitis
- Radiculopathy
- Vertebral fracture
- Neurological deficits
- Pregnancy or radiating pain below the gluteal fold.
Plan studiów
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 |
|---|---|
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Eksperymentalny: Bowen Therapy + McGill Stabilization Exercise
Participants received a combined intervention consisting of Bowen Therapy and McGill stabilization exercises for six weeks.
The McGill exercise program included curl-up, side-bridge, and bird-dog exercises performed three sessions per week on alternate days, with 30 repetitions and a 10-second isometric hold per repetition.
Conventional physiotherapy exercises, including single and double knee-to-chest stretches, prone lying, heel slides, supine bicycling, and bridging exercises, were also provided.
Before each treatment session, participants received a 10-minute moist hot pack and transcutaneous electrical nerve stimulation (TENS).
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Bowen Therapy is a manual therapy involving gentle rolling movements applied over muscles, tendons, ligaments, and fascia using the fingers or thumbs. Treatment consisted of standardized movement sequences with 2-5 minute intervals between sets to facilitate neuromuscular integration. Each session included two to three repetitions per set and four to five sets, administered three times per week for six weeks. The McGill stabilization exercise program consisted of evidence-based core stabilization exercises including the curl-up, side-bridge, and bird-dog. Exercises were performed three times per week on alternate days for six weeks, with 30 repetitions and a 10-second isometric hold during each repetition. Participants also performed conventional physiotherapy exercises, including single and double knee-to-chest stretches, prone lying, heel slides, supine bicycling, and bridging exercises. |
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Aktywny komparator: Bowen Therapy Alone
Participants received Bowen Therapy alone for six weeks.
Bowen Therapy consisted of gentle rolling manual movements applied to muscles, tendons, ligaments, and fascia using the fingers or thumbs, with 2-5 minute intervals between movement sequences.
Each session included two to three repetitions per set and four to five sets following a standardized treatment protocol.
Participants also received standard physiotherapy modalities, including a 10-minute moist hot pack and transcutaneous electrical nerve stimulation (TENS) before each treatment session.
|
Bowen Therapy is a manual therapy involving gentle rolling movements applied over muscles, tendons, ligaments, and fascia using the fingers or thumbs.
Treatment consisted of standardized movement sequences with 2-5 minute intervals between sets to facilitate neuromuscular integration.
Each session included two to three repetitions per set and four to five sets, administered three times per week for six weeks.
Participants in both study groups received Bowen Therapy according to the same standardized protocol.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Pain Intensity Measured by the Numeric Pain Rating Scale (NPRS)
Ramy czasowe: Baseline, Week 2, Week 4, and Week 6
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Pain intensity will be assessed using the 11-point Numeric Pain Rating Scale (NPRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
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Baseline, Week 2, Week 4, and Week 6
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Functional Disability Measured by the Modified Oswestry Disability Index (MODI)
Ramy czasowe: Baseline, Week 2, Week 4, and Week 6
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Functional disability will be assessed using the Modified Oswestry Disability Index (MODI).
Scores range from 0% to 100%, with higher scores indicating greater disability.
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Baseline, Week 2, Week 4, and Week 6
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- Fouladi N, Minoonejad H, Rajabi R. Comparing the effects of the postural restoration exercises with and without core stability exercises in patients with non-specific chronic low back pain. Journal of Modern Rehabilitation. 2023.
- Opara JA, Saulicz E, Szczygiel JW, Szczygiel K. Is the Central Sensitization in Chronic Nonspecific Low Back Pain Structural Phenomenon or Psychological Reaction? A Narrative Review. J Clin Med. 2025 Jan 17;14(2):577. doi: 10.3390/jcm14020577.
- Baek JE, Kim SH, Shin HJ, Cho HY. Effect of a Healing Program Using Marine Resources on Reducing Pain and Improving Physical Function in Patients with Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial Study. Medicina (Kaunas). 2025 Jan 21;61(2):172. doi: 10.3390/medicina61020172.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- IRB-UOL-SMC/001-27/2024
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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