Comparing the Effects of Muscle Energy Technique Versus Myofascial Mobilization in Managing Sub-acute Low Back Pain
Primary Purpose
Lordosis, Low Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Lordosis
Eligibility Criteria
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
Sites / Locations
- Sindh Institute of Physical Medicine and RehabilitationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Muscle Energy Techniques
Myofascial Mobilization Techniques
Arm Description
Following physiotherapy will be given to the participants in this group for 4 weeks, 3 times a week: 1. Muscle Energy Technique
Following physiotherapy will be given to the participants in this group for 4 weeks, 3 times a week: 1. Myofascial Mobilization
Outcomes
Primary Outcome Measures
Visual Analogue Scale
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.
Rolland Morris Disability Questionnaire
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05428280
First Posted
June 13, 2022
Last Updated
June 17, 2022
Sponsor
Dow University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05428280
Brief Title
Comparing the Effects of Muscle Energy Technique Versus Myofascial Mobilization in Managing Sub-acute Low Back Pain
Official Title
Effectiveness of Muscle Energy Technique Versus Myofascial Mobilization in Improving Functional Outcome in Sub-acute Non-specific Low Back Pain: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2021 (Actual)
Primary Completion Date
September 24, 2022 (Anticipated)
Study Completion Date
October 20, 2022 (Anticipated)
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
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lordosis, Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Muscle Energy Techniques
Arm Type
Experimental
Arm Description
Following physiotherapy will be given to the participants in this group for 4 weeks, 3 times a week:
1. Muscle Energy Technique
Arm Title
Myofascial Mobilization Techniques
Arm Type
Active Comparator
Arm Description
Following physiotherapy will be given to the participants in this group for 4 weeks, 3 times a week:
1. Myofascial Mobilization
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
Conventional treatment consisted of Transcutaneous Electrical Nerve Stimulation and Progressive Back Strengthening Exercise
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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.
Time Frame
Change from baseline pain intensity at 4 weeks
Title
Rolland Morris Disability Questionnaire
Description
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)
Time Frame
Change from baseline functional disability at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faizan Abdullah, MSAPT, DPT
Organizational Affiliation
Sindh Institute of Physical Medicine and Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sindh Institute of Physical Medicine and Rehabilitation
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faizan Abdullah, MSAPT, DPT
Phone
03352633476
Email
faizan6faizan@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparing the Effects of Muscle Energy Technique Versus Myofascial Mobilization in Managing Sub-acute Low Back Pain
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