- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05428280
Comparing the Effects of Muscle Energy Technique Versus Myofascial Mobilization in Managing Sub-acute Low Back Pain
March 26, 2024 updated by: Faizan Abdullah, Dow University of Health Sciences
Effectiveness of Muscle Energy Technique Versus Myofascial Mobilization in Improving Functional Outcome in Sub-acute Non-specific Low Back Pain: A Randomized Controlled Trial
Institute for Clinical Systems Improvement (ICSI) defines sub-acute low back pain as low back pain lasting between 4 and 12 weeks.
There is insufficient evidence regarding the comparative effect of muscle energy technique and myofascial mobilization in the management of sub-acute non-specific low back pain with the tightness of quadratus lumborum and erector spinae muscles
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A randomized experimental controlled trial will be carried out to compare the effectiveness of muscle energy technique and myofascial mobilization in the management of sub-acute non-specific low back pain.
A total of 60 male and female volunteers having subjects with sub-acute nonspecific low back pain will be recruited in this study.
Subjects will be assessed at baseline for pain and disability using Visual Analogue Scale and Ronald Morris Disability Questionnaire (RMDQ 0-24) respectively.
After baseline assessment, all subjects will be allocated to two groups through computer-generated random sampling.
Group 1 will perform Muscle energy technique combined with conventional exercise; Group 2 will receive Myofascial Mobilization combined with conventional exercise.
This study will be conducted at the Physiotherapy Department of Sindh Institute of Physical Medicine and Rehabilitation (SIPM&R).
Data will be analyzed using SPSS 21 and ANCOVA technique will be used in this study.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 74200
- Sindh Institute of Physical Medicine and Rehabilitation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Sub-acute low back pain with the range of 7 to 12 weeks of unresolved symptoms.
- Positive test of tight Erector spinae muscle and Tight Quadratus Lumboram muscle
Exclusion Criteria:
- Spinal malignancy
- Spinal fracture
- Spine foraminal stenosis
- Nerve root compression
- Radicular symptoms
- Sciatica
- Cord compression
- Paralysis
- Muscular dystrophy
- Myelopathy
- Seizure disorder
- Severe trauma
- Unexplained weight loss
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
Following physiotherapy will be given to the participants in this group for 4 weeks, 3 times a week: 1. Muscle Energy Technique |
Conventional treatment consisted of Transcutaneous Electrical Nerve Stimulation and Progressive Back Strengthening Exercise
Muscle Energy Technique (MET) is a technique that was developed in 1948 by Fred Mitchell, Sr, D.O[1].
It is a form of manual therapy, widely used in Osteopathy, that uses a muscle's own energy in the form of gentle isometric contractions to relax the muscles via autogenic or reciprocal inhibition and lengthen the muscle.
|
|
Active Comparator: Myofascial Mobilization Techniques
Following physiotherapy will be given to the participants in this group for 4 weeks, 3 times a week: 1. Myofascial Mobilization |
Conventional treatment consisted of Transcutaneous Electrical Nerve Stimulation and Progressive Back Strengthening Exercise
It is a type of gentle, constant massage that releases tightness and pain throughout your myofascial tissues
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: Change from baseline pain intensity at 4 weeks
|
The visual analogue scale is used for measurement of pain intensity.
It is a continuous scale.
It comprises a horizontal or vertical 10 centimeters or 100 millimeters line.
The participant is asked to indicate a point of pain intensity by placing a line perpendicular to the Visual analogue scale line.
The scale is most commonly referred by "no pain" with score of 0 and "worst imaginable pain" with score of 100 on the scale.
The higher scores shows higher pain intensity and lower scores shows lower pain intensity.
|
Change from baseline pain intensity at 4 weeks
|
|
Rolland Morris Disability Questionnaire
Time Frame: Change from baseline functional disability at 4 weeks
|
It is a standard questionnaire with questions regarding pain and the disabling effect on daily activities.
Its score ranges from 0 to 24 (no disability to maximum disability)
|
Change from baseline functional disability at 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Faizan Abdullah, MSAPT, DPT, Sindh Institute of Physical Medicine and Rehabilitation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 22, 2021
Primary Completion (Actual)
November 27, 2023
Study Completion (Actual)
November 27, 2023
Study Registration Dates
First Submitted
June 13, 2022
First Submitted That Met QC Criteria
June 17, 2022
First Posted (Actual)
June 23, 2022
Study Record Updates
Last Update Posted (Actual)
March 27, 2024
Last Update Submitted That Met QC Criteria
March 26, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FAbdullah
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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