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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05428280
Other study ID # FAbdullah
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 22, 2021
Est. completion date November 27, 2023

Study information

Verified date March 2024
Source Dow University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 27, 2023
Est. primary completion date November 27, 2023
Accepts healthy volunteers No
Gender All
Age group 30 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Physiotherapy
Conventional treatment consisted of Transcutaneous Electrical Nerve Stimulation and Progressive Back Strengthening Exercise
Muscle Energy technique
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.
Myofacial mobilization
It is a type of gentle, constant massage that releases tightness and pain throughout your myofascial tissues

Locations

Country Name City State
Pakistan Sindh Institute of Physical Medicine and Rehabilitation Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from baseline pain intensity at 4 weeks
Primary 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) Change from baseline functional disability at 4 weeks
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