- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07724704
McGill Versus Sahrmann's Exercises for Chronic Non-Specific Low Back Pain
Effects of McGill Versus Sahrmann's Protocol on Pain, Range of Motion and Disability in Chronic Non- Specific Low Back Pain
The goal of this clinical trial is to compare the effects of McGill stabilization exercises and Sahrmann's movement-based exercise protocol in adults with chronic non-specific low back pain. The study aims to determine which exercise program is more effective in reducing pain, improving lumbar range of motion, and decreasing functional disability.
The main questions it aims to answer are:
Do McGill stabilization exercises reduce pain, improve lumbar range of motion, and decrease disability in individuals with chronic non-specific low back pain? Are McGill stabilization exercises more effective than Sahrmann's movement-based exercise protocol in improving pain, lumbar range of motion, and functional disability?
Researchers will compare the McGill stabilization exercise group with the Sahrmann exercise group to determine which intervention provides greater improvements in clinical outcomes.
Participants will:
Be randomly assigned to either the McGill stabilization exercise group or the Sahrmann exercise group.
Receive baseline physiotherapy, including hot pack application, Transcutaneous Electrical Nerve Stimulation (TENS), lumbar isometric exercises, pelvic tilts, knee-to-chest exercises, and manual therapy.
Attend supervised treatment sessions 2-3 times per week for 6 weeks. Complete outcome assessments before and after treatment using the Numeric Pain Rating Scale (NPRS) for pain, the Oswestry Disability Index (ODI) for disability, and a bubble inclinometer to measure lumbar range of motion.
This study will provide evidence on the comparative effectiveness of two commonly used physiotherapy exercise protocols and help identify the most effective rehabilitation approach for managing chronic non-specific low back pain.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic non-specific low back pain (CNSLBP) is one of the leading causes of disability worldwide and is associated with persistent pain, reduced spinal mobility, impaired motor control, and limitations in daily activities. Unlike specific low back pain, CNSLBP has no identifiable pathological cause, making rehabilitation through exercise therapy the primary treatment approach. Current clinical guidelines recommend exercise-based interventions to improve pain, function, and quality of life; however, there is no consensus regarding the most effective exercise protocol for individuals with chronic non-specific low back pain.
Among the commonly prescribed physiotherapy interventions are the McGill stabilization exercise program and Sahrmann's movement-based exercise protocol. The McGill approach focuses on enhancing spinal stability by improving core muscle endurance and minimizing excessive spinal loading through spine-sparing stabilization exercises. In contrast, Sahrmann's protocol emphasizes correction of movement impairments, restoration of normal lumbopelvic movement patterns, and activation of deep stabilizing muscles to improve motor control and functional movement.
Although both rehabilitation approaches have demonstrated beneficial effects when studied individually, direct comparative evidence regarding their effectiveness in improving pain, lumbar range of motion, and functional disability remains limited. Existing studies have primarily evaluated each intervention separately or compared them with conventional physiotherapy rather than with each other. Consequently, clinicians have limited evidence to guide the selection of the most appropriate exercise protocol for patients with chronic non-specific low back pain.
This randomized controlled trial is designed to compare the clinical effectiveness of McGill stabilization exercises and Sahrmann's movement-based exercise protocol in adults with chronic non-specific low back pain. Clinical outcomes will be evaluated using validated measures of pain intensity, lumbar range of motion, and functional disability before and after the intervention period. The findings are expected to clarify whether one exercise approach provides superior improvements in patient outcomes and functional recovery.
The results of this study will contribute to evidence-based physiotherapy practice by providing comparative evidence on two widely used rehabilitation protocols. Identifying the more effective intervention may assist physiotherapists in selecting appropriate exercise programs, improving clinical decision-making, optimizing rehabilitation outcomes, and supporting the development of standardized conservative management strategies for individuals with chronic non-specific low back pain.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
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Punjab Province
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Lahore, Punjab Province, Pakistan, 60000
- Recruiting
- Lahore Clinic Shujabad, THQ Hospital Shujabad
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Contact:
- Annum Manzoor, MS-OMPT
- Phone Number: 03324880984
- Email: drannummanzoor20@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Adults aged 20-50 years.
- Male and female participants.
- Diagnosed with chronic non-specific low back pain lasting more than 12 weeks.
- Pain intensity of 3-4 on the Numeric Pain Rating Scale (NPRS) at baseline.
- Able and willing to participate in the exercise program and attend all treatment sessions.
- Willing to provide written informed consent.
Exclusion Criteria
- History of spinal surgery.
- Presence of neurological deficits.
- Structural spinal deformities.
- Pregnancy or within 6 months postpartum.
- Presence of red flag signs or systemic illness (e.g., fracture, infection, malignancy, inflammatory disorders).
- Individuals unable or unwilling to participate in the exercise program or complete the study protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: McGill Stabilization Exercise Group
Participants in this group will receive the McGill stabilization exercise protocol in addition to baseline physiotherapy.
The exercise program is designed to improve core stability, spinal stability, lumbar range of motion, reduce pain, and improve functional ability in individuals with chronic non-specific low back pain.
The intervention will be administered according to the study protocol for 6 weeks.
|
A progressive exercise program consisting of McGill stabilization exercises aimed at enhancing core muscle endurance, spinal stability, and neuromuscular control while reducing pain and improving lumbar function in individuals with chronic non-specific low back pain.
|
|
Experimental: Sahrmann's Exercise Protocol Group
Participants in this group will receive the Sahrmann's movement-based exercise protocol in addition to baseline physiotherapy.
The program focuses on improving lumbopelvic control, correcting movement impairments, restoring normal movement patterns, reducing pain, increasing lumbar range of motion, and improving functional ability over a 6-week intervention period.
|
A progressive movement-based exercise program designed to improve motor control, activate deep stabilizing muscles, correct faulty movement patterns, and enhance functional performance in individuals with chronic non-specific low back pain.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1. Numeric Pain Rating Scale (NPRS)
Time Frame: [Time Frame: 6 Weeks]
|
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS).
The NPRS is a valid and reliable self-reported pain assessment tool that measures pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst imaginable pain").
Participants will be asked to select the number that best represents their current pain intensity.
A decrease in the NPRS score indicates an improvement in pain following the intervention.
|
[Time Frame: 6 Weeks]
|
|
2. Oswestry Disability Index (ODI)
Time Frame: [Time Frame: 6 Weeks]
|
Functional disability will be assessed using the Oswestry Disability Index (ODI).
The ODI is a disease-specific, validated questionnaire used to evaluate disability associated with chronic low back pain.
It consists of 10 sections covering pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, travelling, and employment/homemaking.
Each section is scored from 0 to 5, with higher total scores indicating greater disability.
A reduction in the ODI score reflects improvement in functional status and daily activities.
|
[Time Frame: 6 Weeks]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
3. Bubble Inclinometer
Time Frame: [Time Frame: 6 Weeks]
|
Lumbar range of motion (ROM) will be measured using a bubble inclinometer, a reliable and valid instrument for assessing spinal mobility.
Measurements will be obtained for lumbar flexion, extension, right and left lateral flexion, and right and left rotation according to standardized measurement procedures.
The bubble inclinometer provides objective assessment of lumbar spinal movement in degrees.
An increase in lumbar range of motion indicates improvement following the intervention.
|
[Time Frame: 6 Weeks]
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Annum Manzoor, MS OMPT, Gulab Devi Teaching institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/25/0146
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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