- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07659327
Effects Of Sahrmann's Versus McGill Exercise In Patients With Non-Specific Low Back Pain
Effects Of Sahrmann's Versus McGill Exercise On Pain, Disability, And Range Of Motion In Patients With Non-Specific Low Back Pain
The goal of this clinical trial is to learn whether Sahrmann exercises or McGill exercises are more effective for reducing pain and improving function in adults with non-specific low back pain. It will also evaluate which exercise program is more effective in improving spinal range of motion.
The main questions it aims to answer are:
Do Sahrmann exercises reduce pain more effectively than McGill exercises? Do Sahrmann exercises improve disability more effectively than McGill exercises? Do Sahrmann exercises improve lumbar range of motion more effectively than McGill exercises?
Researchers will compare a Sahrmann exercise program with a McGill exercise program to determine which approach produces better outcomes in patients with non-specific low back pain.
Participants will:
Be randomly assigned to either a Sahrmann exercise group or a McGill exercise group.
Receive standard physical therapy treatment, including heat therapy and transcutaneous electrical nerve stimulation (TENS).
Perform the assigned exercise program under the supervision of a physiotherapist.
Attend exercise sessions 3-5 times per week during the study period. Complete assessments of pain, disability, and lumbar range of motion before and after the intervention.
Have pain measured using the Numeric Pain Rating Scale (NPRS), disability measured using the Oswestry Disability Index (ODI), and lumbar range of motion measured using a Baseline Bubble Inclinometer.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Non-specific low back pain (NSLBP) is one of the most prevalent musculoskeletal disorders and a major cause of disability worldwide. It is characterized by pain localized between the lower rib margins and the gluteal folds without a specific identifiable pathology. Individuals with NSLBP often experience pain, reduced spinal mobility, impaired motor control, and functional limitations that negatively affect daily activities and quality of life.
Exercise-based rehabilitation is widely recommended as a first-line treatment for NSLBP. Core stabilization exercises have gained considerable attention because deficits in trunk muscle function and lumbopelvic stability are believed to contribute to the persistence and recurrence of low back pain. Among the commonly used approaches, Sahrmann exercises and McGill exercises are designed to improve spinal stability through different mechanisms.
The Sahrmann approach emphasizes motor control training and the correction of movement impairments through progressive lumbopelvic stabilization exercises. The McGill approach focuses on enhancing spinal stability and muscular endurance while minimizing spinal loading through a series of stabilization exercises commonly referred to as the McGill Big Three. Although both approaches are frequently used in rehabilitation practice, evidence directly comparing their effectiveness in individuals with NSLBP remains limited.
This randomized controlled trial aims to compare the effects of Sahrmann exercises and McGill exercises on clinical outcomes in adults with non-specific low back pain. Participants will be randomly allocated to one of two treatment groups and will receive a supervised exercise program in addition to standard physical therapy care. Clinical assessments will be conducted before and after the intervention period to evaluate changes in pain, functional disability, and lumbar mobility.
The findings of this study may help identify the more effective exercise-based rehabilitation approach for individuals with non-specific low back pain and provide evidence to support clinical decision-making in physical therapy practice.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Sumrod Akram
- Numer telefonu: 03324806143
- E-mail: samrood.akram@riphah.edu.pk
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Diagnosed patients of non-specific low back pain Adults between 18-35 years. Both male and female included Low back pain for minimum of three months NPRS score 3-7 will be recruited in this study.
Exclusion Criteria:
History of any trauma and spinal injury History of previous lumbar surgery History of cancer, spinal infection, rheumatologic diseases, spine fracture, red flag signs.
Congenital anomly (scoliosis, kyphosis) Systemic diseases affecting bones & joints such as rheumatoid arthritis
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: Group A: (Sahrmann's Exercises)
The patients in this group will receive conventional Sahrmann's exercises along with baseline treatment for non-specific low back pain.
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Group A will receive sahrmann's exercises after the baseline treatment. It will be including 5 levels: Level 1 The participant slowly raised one leg to a position of approximately 90° hip flexion with 90° knee flexion. Level 2 From the final position of the previous level, the participant slowly lowered one leg such that the heel contacted the ground/plinth. Level 3 From the end position of level 1, the participant slowly lowered one leg such that the heel reached approximate 12cm above the ground. Then the leg slid out to fully extend the knee. Level 4 From the final position of level 1, the participant slowly lowered both legs together such that the heels contacted the plinth. Then the legs slid out to fully extend the knees. Level 5 From the final position of level 1, the participant slowly lowered both legs simultaneously such that the heels reached 12 cm above the ground. The legs then slid out to fully extend the knees. |
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Aktywny komparator: Group B: (McGill Exercises)
The patients in this group will receive McGill Exercises along with baseline treatment for non-specific low back pain.
|
Patients will receive three exercises for rehabilitating lower back pain, termed the McGill Big Three (MGB3). Mcgill begins with motion exercise (cat-camel motion exercise. It consists of six to eight cycle of spinal flexion and extension in quadruped position.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Numerical Pain Rating Scale (NPRS)
Ramy czasowe: upto 6 weeks
|
In the current study, patients with NPRS score 3-7 will be recruited.
Patient level of pain will be assessed using this scale.
NRS is 11-points (NRS-11) which counts the pain and is wildly used in clinical settings because it is easy to administer and score.
The patient is asked to indicate the value of his pain on the scale.
A 11-point scale was used, with "0" representing "no pain" and "10" representing the "most severe pain imaginable" at the time of assessment (10).
The Numeric Pain Rating Scale (NPRS) demonstrates moderate to excellent test-retest reliability with ICC values ranging from 0.58 to 0.93, and good construct validity with correlation coefficients of 0.48 to 0.54
|
upto 6 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Oswestry Disability Index (ODI)
Ramy czasowe: upto 6 weeks
|
The ODI was the primary outcomes used to assess self-reports of disability caused by LBP.
The ODI is made up of 10 sections scored from 0 to 5 points, each section contain 6 statements with the total score ranging from 0 to 50 points.
A higher score on questionnaires indicates a higher level of disability.
The ODI (ICC > 0.84) has been recognized as valid and reliable tools for patients suffering from chronic LBP.
|
upto 6 weeks
|
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Baseline Bubble Inclinometer
Ramy czasowe: upto 6 weeks
|
A Baseline Bubble Inclinometer (Model 10602 built by Fabrication Enterprise Inc., USA) was used to measure the active back flexion and extension range of motion without thoraco-lumbar pain.
To evaluate the active thoraco-lumbar flexion and extension range of motion, the inclinometer was used at the T12-L1 spinous process.
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upto 6 weeks
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Fatima Khan, MSPT*, Riphah International University
Publikacje i pomocne linki
Publikacje ogólne
- Hlaing SS, Puntumetakul R, Khine EE, Boucaut R. Effects of core stabilization exercise and strengthening exercise on proprioception, balance, muscle thickness and pain related outcomes in patients with subacute nonspecific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2021 Nov 30;22(1):998. doi: 10.1186/s12891-021-04858-6.
- Ghorbanpour A, Azghani MR, Taghipour M, Salahzadeh Z, Ghaderi F, Oskouei AE. Effects of McGill stabilization exercises and conventional physiotherapy on pain, functional disability and active back range of motion in patients with chronic non-specific low back pain. J Phys Ther Sci. 2018 Apr;30(4):481-485. doi: 10.1589/jpts.30.481. Epub 2018 Apr 13.
- Bielewicz J, Daniluk B, Kamieniak P. VAS and NRS, Same or Different? Are Visual Analog Scale Values and Numerical Rating Scale Equally Viable Tools for Assessing Patients after Microdiscectomy? Pain Res Manag. 2022 Mar 29;2022:5337483. doi: 10.1155/2022/5337483. eCollection 2022.
- Ahmad SNS, Letafatkar A, Brewer BW, Sharifnezhad A. Comparison of cognitive functional therapy and movement system impairment treatment in chronic low back pain patients: a randomized controlled trial. BMC Musculoskelet Disord. 2023 Aug 29;24(1):684. doi: 10.1186/s12891-023-06815-x.
- Hernandez-Lucas P, Leiros-Rodriguez R, Mota J, Garcia-Soidan JL. Effects of a back school-based intervention on non-specific low back pain in adults: a randomized controlled trial. BMC Complement Med Ther. 2023 Jul 10;23(1):229. doi: 10.1186/s12906-023-04061-1.
- Niroomand T, Rabiei M, Mohammadi BJJoAST. Investigating the Effects Janda's and Sahrmann's Correcting Exercise Approaches on Trunk Muscles Function in Young Girls with Lower Crossed Syndrome. 2023;7(3):48-58.
- Alkhathami K, Alshehre Y, Brizzolara K, Weber M, Wang-Price S. Effectiveness of Spinal Stabilization Exercises on Movement Performance in Adults with Chronic Low Back Pain. Int J Sports Phys Ther. 2023 Feb 1;18(1):169-172. doi: 10.26603/001c.68024. eCollection 2023.
- Chan EWM, Hamid MSA, Nadzalan AM, Hafiz E. Abdominal muscle activation: An EMG study of the Sahrmann five-level core stability test. Hong Kong Physiother J. 2020 Dec;40(2):89-97. doi: 10.1142/S1013702520500080. Epub 2020 Mar 10.
- Alonso-Sal A, Alonso-Perez JL, Sosa-Reina MD, Garcia-Noblejas-Fernandez JA, Balani-Balani VG, Rossettini G, Villafane JH. Effectiveness of Physical Activity in the Management of Nonspecific Low Back Pain: A Systematic Review. Medicina (Kaunas). 2024 Dec 16;60(12):2065. doi: 10.3390/medicina60122065.
- Morotani M. General principles of the Movement System Impairment diagnostic system. The Journal of Manual Physical Therapy. 2022;22(1):29-35.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
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
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- REC/RCR & AHS/25/0137
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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Badania kliniczne na Sahrmann's Exercises
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Cukurova UniversityZakończonyZespół nadpobudliwości psychoruchowej z deficytem uwagi (ADHD)Turcja (Türkiye)
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Cairo UniversityJeszcze nie rekrutacjaBól szyi Mięśniowo-szkieletowyEgipt