Clinical trial NCT05167435: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Chronic Pain
Disabled Persons
Myofascial Release
Low back pain
Back pain
Exercise Therapy
Quality of life
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline in pain on Short Form McGill Questionnaire 2 (SFMPQ-2) at 6 weeks (post intervention).
timeFrame: Baseline and Post Intervention
measure: Change from baseline in pain on Short Form McGill Questionnaire 2 (SFMPQ-2) at 12 weeks follow-up.
timeFrame: Baseline and 12 weeks follow-up
measure: Change from 6 weeks (post intervention) in pain on Short Form McGill Questionnaire 2 (SFMPQ-2) at 12 weeks follow-up.
timeFrame: Post Intervention and 12 weeks follow-up
measure: Change from baseline in disability on the Roland Morris Disability Questionnaire at 6 weeks (post intervention)..
timeFrame: Baseline and Post Intervention
measure: Change from baseline in disability on the Roland Morris Disability Questionnaire at 12 weeks follow-up.
timeFrame: Baseline and 12 weeks follow-up
measure: Change from 6 weeks (post intervention) in disability on the Roland Morris Disability Questionnaire at 12 weeks follow-up.
timeFrame: Post Intervention and 12 weeks follow-up
measure: Change from baseline in Quality of life on the WHOQOL BREF at 6 weeks (post intervention).
timeFrame: Baseline and Post Intervention
measure: Change from baseline in Quality of life on the WHOQOL BREF at 12 weeks follow-up.
timeFrame: Baseline and 12 weeks follow-up
measure: Change from 6 weeks (post intervention) in Quality of life on the WHOQOL BREF at 12 weeks follow-up.
timeFrame: Post Intervention and 12 weeks follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: Sindh
city: Karachi
country: Pakistan
facility: Dr. Ruth.K.M.Pfau Civil Hospital
state: Sindh
city: Karachi
country: Pakistan
facility: Sindh Institute o Physical Medicine and Rehabilitation
state: Sindh
Study officials:
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