- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07470307
Dynamic Lumbar Strengthening Exercises Versus Pilates, Combined With Myofascial Release in Non Specific Chronic Low Back Pain
This randomized controlled trial aims to compare the effectiveness of dynamic lumbar strengthening exercises combined with myofascial release versus Pilates combined with myofascial release in individuals with non-specific chronic low back pain.
Non-specific chronic low back pain is one of the most common musculoskeletal disorders affecting adults and is associated with pain, reduced spinal mobility, and functional disability. Exercise-based rehabilitation programs and manual therapy techniques are commonly used to improve functional outcomes in these patients. Dynamic lumbar strengthening exercises focus on improving spinal stability and strengthening trunk musculature, whereas Pilates exercises emphasize core muscle activation, postural control, and controlled movement patterns. Myofascial release is a manual therapy technique used to reduce fascial restrictions, improve soft tissue mobility, and decrease pain.
In this randomized controlled trial, a total of 60 participants aged between 25 and 35 years with non-specific chronic low back pain lasting more than three months will be recruited from the Physiotherapy Department of the University of Lahore Teaching Hospital. Participants will be randomly allocated into two groups. Group A will receive dynamic lumbar strengthening exercises combined with myofascial release, while Group B will receive Pilates exercises combined with myofascial release.
Both groups will also receive baseline therapy consisting of therapeutic massage, interferential therapy, and therapeutic ultrasound applied to the lumbosacral region. The exercise programs will be conducted for eight weeks on alternate days, with each session lasting approximately 20-25 minutes.
Outcome measures will include pain intensity assessed using the Visual Analog Scale (VAS), functional disability measured using the Oswestry Disability Index (ODI), and lumbar range of motion measured using an inclinometer. Assessments will be conducted at baseline before the intervention and after completion of the 8-week intervention period.
The findings of this study will help determine which exercise approach combined with myofascial release is more effective in reducing pain, improving functional disability, and enhancing spinal mobility in individuals with non-specific chronic low back pain. The results may contribute to evidence-based physiotherapy management and improve rehabilitation strategies for patients with chronic low back pain.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Non-specific chronic low back pain (NSCLBP) is a prevalent musculoskeletal condition that significantly affects quality of life, physical function, and work productivity. It is characterized by persistent pain in the lumbar region lasting longer than three months without a specific identifiable pathology. Conservative physiotherapy interventions including therapeutic exercises and manual therapy techniques are commonly used to manage symptoms and improve functional outcomes.
Dynamic lumbar strengthening exercises are designed to enhance spinal stability by strengthening key trunk muscles such as the erector spinae, rectus abdominis, and other core stabilizers. These exercises improve neuromuscular control, spinal support, and functional movement patterns. Pilates-based exercises, on the other hand, focus on controlled movements, core stabilization, breathing control, and activation of deep stabilizing muscles including the transversus abdominis and multifidus.
Myofascial release (MFR) is a manual therapy technique that applies gentle sustained pressure and stretching to fascial tissues to reduce fascial restrictions, improve tissue mobility, and relieve musculoskeletal pain. Combining exercise therapy with myofascial release may enhance therapeutic outcomes in individuals with chronic low back pain.
This randomized controlled trial will be conducted at the Physiotherapy Department of the University of Lahore Teaching Hospital. A total of 60 participants aged 25-35 years diagnosed with non-specific chronic low back pain for more than three months will be recruited using convenient sampling. Participants meeting the inclusion criteria will provide written informed consent prior to enrollment.
Participants will be randomly allocated into two groups using a computer-generated randomization method:
Group A: Dynamic lumbar strengthening exercises combined with myofascial release.
Group B: Pilates exercises combined with myofascial release.
Both groups will receive baseline treatment consisting of therapeutic massage techniques (effleurage, petrissage, stripping, friction, and tapotement), interferential therapy, and therapeutic ultrasound applied to the lumbosacral region.
The exercise intervention will be conducted for eight weeks on alternate days, with each session lasting approximately 20-25 minutes. Dynamic lumbar strengthening exercises will include movements such as bird dog, glute bridge, dead bug, side-lying leg lifts, and modified superman. The Pilates program will include exercises such as pelvic tilts, pelvic curl, modified hundred, single-leg stretch, swimming, and knee folds, performed with emphasis on core activation and controlled breathing.
Myofascial release techniques will be applied to the thoracolumbar fascia in the prone position using standardized manual techniques including sustained pressure, longitudinal gliding, and bilateral or unilateral fascial stretching.
Outcome measures will include pain intensity measured using the Visual Analog Scale (VAS), functional disability assessed using the Oswestry Disability Index (ODI), and lumbar range of motion measured using an inclinometer. Assessments will be conducted at baseline and after completion of the 8-week intervention.
The results of this study are expected to provide evidence regarding the comparative effectiveness of dynamic lumbar strengthening exercises versus Pilates exercises when combined with myofascial release for the management of non-specific chronic low back pain.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Montiha Azeem, MSPTN
- Phone Number: 03479717317
- Email: muntahaazeem9@gmail.com
Study Contact Backup
- Name: Maheen Rauf, MS MSK
- Phone Number: 0303 8452456
- Email: maheenrauf08@gmail.com
Study Locations
-
-
Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- University of Lahore Teaching Hospital, Lahore
-
Contact:
- Montiha Azeem, MSPTN
- Phone Number: 03479717317
- Email: muntahaazeem9@gmail.com
-
Contact:
- Maheen Rauf, MS MSK
- Phone Number: 03038452456
- Email: maheenrauf08@gmail.com
-
Principal Investigator:
- Maheen Rauf, MS MSK
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Male and female aged between 25 to 35 years. History of persistent low back pain for more than 3 months. Pain intensity with a score > 3 on the Visual Analog Scale (VAS). Functional disability measured by the Oswestry Disability Index (ODI), with scores ranging from 20% to 60%
Exclusion Criteria:
Individuals with acute or subacute low back pain. Presence of systemic illnesses or specific spinal pathologies. Psychological disorders such as severe anxiety or depression affecting participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group A Dynamic Lumbar Strengthening Exercises with Myofascial Release
Participants in this group will receive dynamic lumbar strengthening exercises combined with myofascial release therapy for the management of non-specific chronic low back pain.
The exercise program will include bird dog, glute bridge, dead bug, side-lying leg lifts, and modified superman exercises performed on a mat.
Each session will last approximately 20-25 minutes and will be conducted on alternate days for 8 weeks under the supervision of a physiotherapist.
Myofascial release techniques will be applied to the thoracolumbar fascia using sustained pressure, longitudinal gliding, and fascial stretching techniques for approximately 4-6 minutes per session.
Participants will also receive baseline therapy including therapeutic massage, interferential therapy, and therapeutic ultrasound applied to the lumbosacral region.
|
Dynamic lumbar strengthening exercises will be performed to improve spinal stability and strengthen trunk musculature in individuals with non-specific chronic low back pain.
The exercise program will include bird dog, glute bridge, dead bug, side-lying leg lifts, and modified superman exercises.
Sessions will be conducted on a mat under the supervision of a physiotherapist.
Each session will last approximately 20-25 minutes and will be performed on alternate days for a total duration of 8 weeks.
Exercise intensity and repetitions will be gradually progressed according to the participant's tolerance while maintaining correct posture and controlled movement.
|
|
Active Comparator: group B Pilates Exercises with Myofascial Release
Participants in this group will receive Pilates-based exercises combined with myofascial release therapy for the treatment of non-specific chronic low back pain.
The Pilates program will focus on core stabilization, breathing control, and spinal mobility.
Exercises will include pelvic tilts, pelvic curl, modified hundred, single-leg stretch, swimming, and knee folds performed on a mat.
Each session will last approximately 20-25 minutes and will be conducted on alternate days for a period of 8 weeks under physiotherapist supervision.
Myofascial release techniques will be applied to the thoracolumbar fascia using standardized manual techniques for approximately 4-6 minutes per session.
Participants will also receive baseline therapy including therapeutic massage, interferential therapy, and therapeutic ultrasound applied to the lumbosacral region.
|
Participants will receive Pilates-based exercises combined with myofascial release therapy for the treatment of non-specific chronic low back pain.
The Pilates program will focus on core muscle activation, breathing control, and spinal mobility.
Exercises will include pelvic tilts, pelvic curl (bridge), modified hundred, single-leg stretch, swimming exercise, and knee folds performed on a mat under physiotherapist supervision.
Each session will last approximately 20-25 minutes and will be conducted on alternate days for 8 weeks.
Myofascial release techniques will be applied to the thoracolumbar fascia using standardized manual therapy techniques for approximately 4-6 minutes per session
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity Measured by Visual Analog Scale (VAS)
Time Frame: Baseline, 2 weeks and after 8 weeks
|
Pain intensity will be assessed using the Visual Analog Scale (VAS).
The VAS consists of a 10-cm horizontal line anchored with two descriptors: "no pain" at 0 and "worst imaginable pain" at 10. Participants will mark their perceived pain intensity on the line, and the score will be recorded in centimeters to quantify pain severity.
|
Baseline, 2 weeks and after 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maheen Rauf, MS MSK, The University of Lahore, Lahore
Study record dates
Study Major Dates
Study Start (Estimated)
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
- UOL/IREB/25/15/03/19
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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