Back to resultsMyofascial Release Technique vs Posterior-anterior Glide on Non-specific Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Myofascial Release Experimental
Posterior-Anterior Glide
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Chronic Pain, Disabled Persons, Myofascial Release, Low back pain, Back pain, Exercise Therapy, Quality of life
Eligibility Criteria
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
Sites / Locations
- Dow University of Health Sciences
- Dr. Ruth.K.M.Pfau Civil Hospital
- Sindh Institute o Physical Medicine and Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A (Intervention)
Group B (Control)
Arm Description
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
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)
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05167435
First Posted
November 25, 2021
Last Updated
February 19, 2022
Sponsor
Dow University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05167435
Brief Title
Myofascial Release Technique vs Posterior-anterior Glide on Non-specific Low Back Pain
Official Title
Myofascial Release Technique vs Posterior-anterior Glide on Non-specific Low Back Pain: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Chronic Pain, Disabled Persons, Myofascial Release, Low back pain, Back pain, Exercise Therapy, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Outcomes assessor involved in the clinical trial will be prevented from having knowledge of the interventions assigned to individual participants.
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A (Intervention)
Arm Type
Experimental
Arm Description
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
Arm Title
Group B (Control)
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Myofascial Release Experimental
Intervention Description
Myofascial release is a gentle sustained pressure that elongates fascial adhesions so that tissue can return to proper realignment.
Intervention Type
Other
Intervention Name(s)
Posterior-Anterior Glide
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from baseline in pain on Short Form McGill Questionnaire 2 (SFMPQ-2) at 6 weeks (post intervention).
Description
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.
Time Frame
Baseline and Post Intervention
Title
Change from baseline in pain on Short Form McGill Questionnaire 2 (SFMPQ-2) at 12 weeks follow-up.
Description
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.
Time Frame
Baseline and 12 weeks follow-up
Title
Change from 6 weeks (post intervention) in pain on Short Form McGill Questionnaire 2 (SFMPQ-2) at 12 weeks follow-up.
Description
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.
Time Frame
Post Intervention and 12 weeks follow-up
Title
Change from baseline in disability on the Roland Morris Disability Questionnaire at 6 weeks (post intervention)..
Description
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.
Time Frame
Baseline and Post Intervention
Title
Change from baseline in disability on the Roland Morris Disability Questionnaire at 12 weeks follow-up.
Description
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.
Time Frame
Baseline and 12 weeks follow-up
Title
Change from 6 weeks (post intervention) in disability on the Roland Morris Disability Questionnaire at 12 weeks follow-up.
Description
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.
Time Frame
Post Intervention and 12 weeks follow-up
Title
Change from baseline in Quality of life on the WHOQOL BREF at 6 weeks (post intervention).
Description
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.
Time Frame
Baseline and Post Intervention
Title
Change from baseline in Quality of life on the WHOQOL BREF at 12 weeks follow-up.
Description
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.
Time Frame
Baseline and 12 weeks follow-up
Title
Change from 6 weeks (post intervention) in Quality of life on the WHOQOL BREF at 12 weeks follow-up.
Description
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.
Time Frame
Post Intervention and 12 weeks follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Dow University of Health Sciences
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan
Facility Name
Dr. Ruth.K.M.Pfau Civil Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75950
Country
Pakistan
Facility Name
Sindh Institute o Physical Medicine and Rehabilitation
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75950
Country
Pakistan
12. IPD Sharing Statement
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Myofascial Release Technique vs Posterior-anterior Glide on Non-specific Low Back Pain
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