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Completed

NCT Number: NCT05167435

Myofascial Release Technique vs Posterior-anterior Glide on Non-specific Low Back Pain

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.

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Key information

Conditions

Low Back Pain Back Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dow University of Health Sciences, Karachi, Sindh, Pakistan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myofascial Release Experimental

Other

Myofascial release is a gentle sustained pressure that elongates fascial adhesions so that tissue can return to proper realignment.

Posterior-Anterior Glide

Other

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 outcomes

  1. Change from baseline in pain on Short Form McGill Questionnaire 2 (SFMPQ-2) at 6 weeks (post intervention).

    Time frame: Baseline and 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.

  2. Change from baseline in pain on Short Form McGill Questionnaire 2 (SFMPQ-2) at 12 weeks follow-up.

    Time frame: Baseline and 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.

  3. Change from 6 weeks (post intervention) in pain on Short Form McGill Questionnaire 2 (SFMPQ-2) at 12 weeks follow-up.

    Time frame: Post Intervention and 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.

  4. Change from baseline in disability on the Roland Morris Disability Questionnaire at 6 weeks (post intervention)..

    Time frame: Baseline and 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.

  5. Change from baseline in disability on the Roland Morris Disability Questionnaire at 12 weeks follow-up.

    Time frame: Baseline and 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.

  6. Change from 6 weeks (post intervention) in disability on the Roland Morris Disability Questionnaire at 12 weeks follow-up.

    Time frame: Post Intervention and 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.

  7. Change from baseline in Quality of life on the WHOQOL BREF at 6 weeks (post intervention).

    Time frame: Baseline and 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.

  8. Change from baseline in Quality of life on the WHOQOL BREF at 12 weeks follow-up.

    Time frame: Baseline and 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.

  9. Change from 6 weeks (post intervention) in Quality of life on the WHOQOL BREF at 12 weeks follow-up.

    Time frame: Post Intervention and 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.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

Myofascial Release Technique vs Posterior-anterior Glide on Non-specific Low Back Pain: a Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 22, 2021
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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