Myofascial Release Technique vs Posterior-anterior Glide on Non-specific Low Back Pain

Study Overview
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Brief Summary
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The objective of this randomized control trial is to determine the effectiveness of myofascial release in patients with nonspecific low back pain to improve Pain, Disability, and Quality of life This study is being conducted at the Outpatient Physiotherapy department of Sindh Institute of Physical Medicine and Rehabilitation, Karachi (former institute of Dow University of Health Sciences) and Musculoskeletal outpatient department of Dr. Ruth K. M. Pfau, Civil Hospital Karachi among 72 patients with nonspecific back pain on the basis of non-probability purposive sample technique with screening for study criteria through a consultant physician (blinded). After taking informed consent, all participants will be randomly allocated into two groups through a second researcher who is not involved in screening, baseline assessment, and providing intervention. Group 1 will receive myofascial release with generalized low back stretching and thermotherapy and Group 2 will receive Posterior-anterior glide with generalized low back stretching and thermotherapy. A total of 18 sessions will be provided. Outcomes will be assessed at baseline, at the last session, and after 12 weeks of follow-up.

Official Title
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Myofascial Release Technique vs Posterior-anterior Glide on Non-specific Low Back Pain: a Randomized Controlled Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Myofascial Release Experimental
* Other: Posterior-Anterior Glide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nonspecific low back pain > 3 months 8 and 45 years of age IPMR and civil musculoskeletal outpatient department patients Without referred leg pain Exclusion Criteria: Any trauma, spinal infection or tumor, spinal fracture, previous spinal surgery, systemic disease, fibromyalgia, cauda equine syndrome, serious chronic disease, specific neurological disease (stroke, MS, and Parkinson's disease) Uncontrolled diabetes or hypertension Pregnant females Spondylolisthesis, spinal stenosis, spondylolysis, ankylosing spondylitis, structural deformity, congenital deformation, disc disease, sacroiliitis, severe structural deformity, scoliosis, active structural deficit, and severe postural abnormality Acute coronary disease Asthmatic patients Any contraindication prescribed for myofascial treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It is a randomized controlled trial. Total 80 patients will be recruited, 40 in each group that includes 4 patients as a dropout in both groups. There will be one interventional group and one control group. Treatment will be allocated using a random number sheet generated by SPSS software version 21. Participants are assigned to one of two groups in parallel for the duration of the study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (Intervention)<br>Myofascial release (Following Cross-hand release techniques of myofascial release in a manner of 2 minutes approach: Cross-Hand Release of Back [For Thoracolumbar Fascia] Cross-Hand Release of the Lumbosacral Junction [L5-S1] Cross-Hand Release of Lateral low back area [for quadratus lumborum]) will be provided with conventional therapy including stretching exercises (Stretching of Latissimus Dorsi [10 seconds hold, 10 reps, 2 sets], Quadratus Lumborum Stretching [10 seconds hold, 3 reps, 1 set bilaterally], Lower Back Stretching [10 seconds hold, 10 reps, 2 sets], Hamstring Stretching [10 seconds hold, 10 reps, 2 sets bilaterally], Tensor Fasciae Latae Stretching [10 sec hold, 10 reps, 2 sets bilaterally] with duration rest will be of thirty seconds after five minutes) and Thermotherapy will be given for 20 minutes | Other: Myofascial Release Experimental<br>* Myofascial release is a gentle sustained pressure that elongates fascial adhesions so that tissue can return to proper realignment.<br>|
| Active Comparator: Group B (Control)<br>Posterior-anterior glide: Grade 1-4 [depending on tolerance] (120 oscillations per minute x 3 sets, Duration of rest between each set: 30 seconds) will be provided with the same conventional therapy as in Group A (Intervention) | Other: Posterior-Anterior Glide<br>* Posterior-anterior mobilization is a standard assessment and treatment technique for most clinicians. It is a mobilization technique that involves passive oscillatory movements applied to a vertebral segment in a posteroanterior direction (Back to front).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pain on Short Form McGill Questionnaire 2 (SFMPQ-2) at 6 weeks (post intervention). | The patient will be asked to mark the Quality and Intensity of pain on a scale of 0-10 that measures the level of pain. The 0 refers no pain and 10 refers worse possible pain and perceived as maximum. | Baseline and Post Intervention | 
| Change from baseline in pain on Short Form McGill Questionnaire 2 (SFMPQ-2) at 12 weeks follow-up. | The patient will be asked to mark the Quality and Intensity of pain on a scale of 0-10 that measures the level of pain. The 0 refers no pain and 10 refers worse possible pain and perceived as maximum. | Baseline and 12 weeks follow-up | 
| Change from 6 weeks (post intervention) in pain on Short Form McGill Questionnaire 2 (SFMPQ-2) at 12 weeks follow-up. | The patient will be asked to mark the Quality and Intensity of pain on a scale of 0-10 that measures the level of pain. The 0 refers no pain and 10 refers worse possible pain and perceived as maximum. | Post Intervention and 12 weeks follow-up | 
| Change from baseline in disability on the Roland Morris Disability Questionnaire at 6 weeks (post intervention).. | A list of 24 sentences will be provided that are found to be difficult to be done by back pain patients. The patient will be asked to mark the sentence. The higher the number of sentences represents the greater intensity of disability means extreme disability. On the other hand the lower the number of sentences marked means the lower the score on the scale for example like 0 (zero) shows no disability. | Baseline and Post Intervention | 
| Change from baseline in disability on the Roland Morris Disability Questionnaire at 12 weeks follow-up. | A list of 24 sentences will be provided that are found to be difficult to be done by back pain patients. The patient will be asked to mark the sentence. The higher the number of sentences represents the greater intensity of disability means extreme disability. On the other hand the lower the number of sentences marked means the lower the score on the scale for example like 0 (zero) shows no disability. | Baseline and 12 weeks follow-up | 
| Change from 6 weeks (post intervention) in disability on the Roland Morris Disability Questionnaire at 12 weeks follow-up. | A list of 24 sentences will be provided that are found to be difficult to be done by back pain patients. The patient will be asked to mark the sentence. The higher the number of sentences represents the greater intensity of disability means extreme disability. On the other hand the lower the number of sentences marked means the lower the score on the scale for example like 0 (zero) shows no disability. | Post Intervention and 12 weeks follow-up | 
| Change from baseline in Quality of life on the WHOQOL BREF at 6 weeks (post intervention). | This questionnaire assess the quality of life within the context of an individual's physical health, psychological, social relationships and environment. Other than these 4 domains 2 questions are asked separately to evaluate an individuals overall perception of quality of life and about an individuals overall perception of their health. The higher the score denote the higher the quality of life and lower score denotes lower quality of life. All 26 assessment questions in the questionnaire has a range of 1-5. 3 of the questions are negatively phrased and so are reversed scored when calculating the domain scores - a score of 5 becomes a 1 and vice versa, a score of 4 becomes a two and vice versa etc. This is performed on questions 3, 4, and 26. You do this before calculating any domain scores. The domain scores are than added to get the final score. | Baseline and Post Intervention | 
| Change from baseline in Quality of life on the WHOQOL BREF at 12 weeks follow-up. | This questionnaire assess the quality of life within the context of an individual's physical health, psychological, social relationships and environment. Other than these 4 domains 2 questions are asked separately to evaluate an individuals overall perception of quality of life and about an individuals overall perception of their health. The higher the score denote the higher the quality of life and lower score denotes lower quality of life. All 26 assessment questions in the questionnaire has a range of 1-5. 3 of the questions are negatively phrased and so are reversed scored when calculating the domain scores - a score of 5 becomes a 1 and vice versa, a score of 4 becomes a two and vice versa etc. This is performed on questions 3, 4, and 26. You do this before calculating any domain scores. The domain scores are than added to get the final score. | Baseline and 12 weeks follow-up | 
| Change from 6 weeks (post intervention) in Quality of life on the WHOQOL BREF at 12 weeks follow-up. | This questionnaire assess the quality of life within the context of an individual's physical health, psychological, social relationships and environment. Other than these 4 domains 2 questions are asked separately to evaluate an individuals overall perception of quality of life and about an individuals overall perception of their health. The higher the score denote the higher the quality of life and lower score denotes lower quality of life. All 26 assessment questions in the questionnaire has a range of 1-5. 3 of the questions are negatively phrased and so are reversed scored when calculating the domain scores - a score of 5 becomes a 1 and vice versa, a score of 4 becomes a two and vice versa etc. This is performed on questions 3, 4, and 26. You do this before calculating any domain scores. The domain scores are than added to get the final score. | Post Intervention and 12 weeks follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pain, Disabled Persons, Myofascial Release, Low back pain, Back pain, Exercise Therapy, Quality of life