- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05479266
Comparison of Muscle Energy Techniques and Myofascial Release on Low Back Pain Due to Sacroiliac Joint Dysfunction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sacroiliac joint is the most common source of low back pain affecting 70-85% of adults. Accordingly, 13-30% of patients with lower back pain have Sacroiliac joint dysfunction. The main mechanism for developing sacroiliac joint dysfunction includes different unidirectional pelvic shear force along with repetitive torsional force and inflammation which produces not only the lower back pain but also groin and gluteal pain. Muscle imbalances has also been sighted as possible cause of pain. This theory states that the sacroiliac joint itself is unaffected, but the musculature surrounding the sacroiliac joint is in form of dysfunction. This muscular imbalance could limit the flexibility of muscle of low back pain and ultimately begin a syndrome of chronic disuse culminating in decreased function and heightened pain. The use of a combination of tests showed a high sensitivity and specificity to indicate the presence of sacroiliac joint dysfunction that includes FABER, posterior shear and resisted abduction pain provocation tests.
Treatment of sacroiliac joint pain is variable and no set method or protocol of treatment has been found to be efficacious and reliable. Interventions to treat pain of SIJ dysfunction includes Non-steroidal Anti-Inflammatory drugs(NSAIDs), physical therapy, corticosteroid injections, osteopathic manipulations(manual medicine), radiofrequency denervation, sacroiliac joint belts and surgery. Muscle Energy Techniques is the most commonly used manual medicine techniques that depends on method of using low amplitude muscle contractions against resistance thinking that it would improve vascular circulation and have a positive influence on static and dynamic posture. this techniques was further modified by having patients use their muscles in a controlled position against a counterforce. Muscle energy techniques have several uses that can help increase muscle strength, increase range of motion(ROM) and decrease edema.
Myofascial release techniques(MFR) are another manual medicine technique that is described as 'designed to stretch and reflexively release patterned soft tissue( particularly the muscles and fascia) and joint related restrictions'. myofascial abnormalities may lead to connective tissue fibrosis, increased tissue stiffness and further movement impairment which may lead to low back pain chronicity.
In a study conducted by D. Sharma et al in 2014 on comparing the effects of muscle energy techniques and mobilizations in treating sacroiliac joint dysfunction focusing on piriformis, quadratus lumborum and erector spinae muscles, concluded that METs and mobilizations are both effective in treating chronic low back pain due to sacroiliac joint dysfunction. Outcomes were measured on first day and then after 1st and 2nd week from each subject, pain and disability by Visual Analogue Scale and Modified Oswestry Disability Index Questionnaire(MODI) In a randomized controlled trial conducted by Arguisuelas et al in 2017 for studying the effects of Myofascial release (MFR) for quadratus lumborum, psoas muscle, thoracolumbar fascia and lumbar paravertebral muscles in Non-specific chronic low back pain , it was concluded that myofascial release therapy produced a significant improvement in both pain and disability. Pain was measured by means of Short Form Mc Gill Pain Questionnaire (SF-MPQ) and Visual Analogue scale and disability measured with Roland Morris Questionnaire.
In another study conducted by Sabah et al in 2019 concluded that muscle energy techniques for iliopsoas, hamstrings, erector spinae and quadratus lumborum is an effective treatment for decreasing anterior pelvic tilting angle and reducing pain in patients with chronic SIJ dysfunction. The study findings revealed a statistical significant decrease of anterior pelvic tilting angle in group A(p<0.001), also a significant decrease in pain in the 2 groups compared with the pre-intervention values(p<0.001) In 2020, Faryal et al conducted a study in peshawar, concluded that muscle energy technique targeting quadratus lumborum, iliopsoas and piriformis muscle and maitland mobilizations are both effective in treating the chronic sacroiliac joint dysfunction in terms of decreasing pain and disability when using lumbopelvic stabilization exercises as an adjunct therapy with them.
In previous studies both muscle energy techniques and myofascial release therapy has been proven to be effective in treating chronic low back pain due to sacroiliac joint dysfunction. Currently to our knowledge there exists very weak evidence to which one technique can be proved to be more effective than the other. The purpose of this study is to compare the effects of both these therapies on pain and functional status in patients with sacroiliac joint dysfunction in addition to conventional physical therapy treatment protocols.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Rawalpindi, Punjab, Pakistan, 46220
- The Health Professionals
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:Participants falling in this category would be recruited into the study.
- Subjects who have had sacroiliac joint pain and hypomobility for 3-6 months
- Muscle tightness
- Only Female Gender
- Age b/w 40-55 years
- Limited Lumber Range of motion (by Inclinometer) (normal ranges flexion: 60 degrees Extension: 35 degrees Side bending: 20 degrees)
- Pain more than 3 on Numeric pain rating scale only
Exclusion Criteria:
- history of systemic illness
- acute injury or fracture in the lower limbs
- any hip joint pathology/infection/malignancy
- previous hip surgery or recently received intra-articular injections
- spinal stenosis/spondylolisthesis/disc disease
- congenital spinal deformity
- hypermobility of sacroiliac joint
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: Muscle Energy Techniques
Muscle Energy Techniques and Conventional Physical Therapy
|
METS-Post isometric relaxation will be applied for piriformis, iliopsoas and hamstrings muscle.
There will be three repetitions for each muscle, once per day and thrice a week for three weeks
Other Names:
|
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Experimental: Myofascial Release
Myofascial Release and Conventional Physical Therapy
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Myofascial Release will be done for piriformis, iliopsoas and hamstrings muscle.
There will be three repetitions for each muscle, once per day and thrice a week for three weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale
Time Frame: 3rd week
|
NPRS is an 11- point numeric scale with 0 representing one pain extreme (e.g no pain) amd 10 representing the other extreme (e.g worst pain imaginable), scores range from 1-10. the highest the score the greater the intensity of pain
|
3rd week
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Modified Oswestry Disability Index
Time Frame: 3rd week
|
this questionnaire consists of 10 items addressing different aspects of function.
Each itemis scored from 0-5, with higher values representing greater disability.
The total score is multiplied by 2 and expressed as percentage.
Fore each section the total possible score is 5.
|
3rd week
|
|
Range of Motion(lumbar spine)
Time Frame: 3rd week
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Lumbar spine flexion, extension and sidebending will be measured with bubble inclinometer
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3rd week
|
|
pelvic tilting
Time Frame: 3rd week
|
pelvic tilting will be measured with pelvic inclinometer
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3rd week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammad Affan Iqbal, PHD, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- RIPHAH/FR&AHS/Letter-0976
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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