- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05272098
Effects of Myofascial Release Therapy and Endurance Training on Mechanical Back Pain
October 17, 2022 updated by: Riphah International University
Comparative Effects of Myofascial Release Therapy and Endurance Training of Trunk Extensor Muscles on Pain, Disability and Muscle Endurance in Patients With Mechanical Back Pain.
This study is a randomized clinical trial to determine the effects of myofascial release therapy versus endurance training of trunk extensor muscles on pain, disability and muscle endurance in patients with mechanical back pain.
A sample of 24 patients will be taken and divided into two groups each with 12 patients.
Group A will receive myofascial release therapy and conventional physical therapy while group B will endurance training of trunk extensors and the conventional physical therapy protocol.
The conventional physical therapy protocol will include a hot pack, back care advice, and postural modifications.
The session will be around 40 to 45 min for each patient with four sessions per week.
A total of four-week treatment regime will be given to the patients and assessment of the patient's pain, disability, and endurance with NPRS (numeric pain rating scale), Rolland Morris Disability Questionnaire and Sorenson Test will be done at the baseline, after the completion of treatment at pre interventional and post interventional to observe the long-term effects.
The data will be analyzed using SPSS.
Study Overview
Status
Completed
Conditions
Detailed Description
Mechanical low back pain is an injury of an anatomic structure in the low back.
It accounts for 97% of cases arising from spinal structures such as bone ligaments, nerves, etc.
In chronic low back pain, exercise therapy has become a first-line treatment and should be routinely used.
Fascia is a form of connective tissue made up of collagen, surrounds the body parts, and resists tissue tensile load.
Fascial injury and adhesions are common and can lead to pain, restricted motion, and swelling.
The treatment of the fascial injury is necessary to relieve those symptoms.
There are many treatments for mechanical back pain and this study focuses on two new treatment techniques for mechanical back pain.
The first is the myofascial release therapy, a manual approach that focuses on the structural segmentation of fascia and involves the application of gentle pressure while stretching the body's connective tissues.
The other treatment technique is the endurance training of the trunk extensor muscles that involve the treatment which is directed to endurance training of erector spinae and latissimus dorsi.
The current study is novel in a way that there is limited literature about myofascial release therapy versus endurance training of trunk extensor muscles in patients with mechanical back pain.
Both methods were employed to see if they improve pain along with accompanying disability and muscle endurance.
Study Type
Interventional
Enrollment (Actual)
24
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
-
-
Punjab
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Multan, Punjab, Pakistan, 60000
- Alkhaliq hospital Nishtar road
-
-
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
20 years to 40 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- History of mechanical low back pain
- Back pain without association with leg pain
Exclusion Criteria:
Any bony, soft tissue or systemic disease
- Pregnant females
- Radiculopathy
- Patient with spinal deformities and fractures
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
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Group A
myofascial release therapy
|
myofascial release therapy (4 sessions per week).
It soft, deep and non-manipulative form of treatment that involves the application of gentle pressure while stretching the body's connective tissue.
A specialized form of touch, somatic sense, and specific body movement protocols are the three steps involved in the myofascial release therapy + hot pack (15min) + back care advice and postural modification.
A total of 45 min session four times a week.
|
|
ACTIVE_COMPARATOR: Group B
endurance training of the trunk extensor muscles
|
It will be treated with endurance training of trunk extensor muscles.
Erector spinae and latissimus dorsi will be included.
The exercise protocol will be in four levels Bilateral shoulder left in prone position+ contralateral arm and leg lift in prone position+ both hands behind head and bilateral shoulder lift +bilateral shoulder lift with arm fully elevated + Hot pack (10 min) + back care advice and postural modification.
A total of 45 min sessions four times a week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NPRS (numeric pain rating scale)
Time Frame: 4th week
|
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10) that best reflects the intensity of his/her pain 11-point numeric scale ranges from '0' representing no pain to 10 representing the worst imaginable pain.
|
4th week
|
|
Rolland Morris Disability Questionnaire
Time Frame: 4th Week
|
It is designed to assess self-rated physical disability caused by low back pain.
This scale has 24 points and each point will tell us about the disability of the patient pre and post-intervention.
The score ranges from 0 (no disability) to 11, 18, or 24 (max.
disability) depending on the questionnaire that is used.
|
4th Week
|
|
Sorenson Test
Time Frame: 4th Week
|
This test measures how many seconds the subject is able to keep the unsupported upper body (from the upper border of the iliac crest) horizontal, while placed prone with the buttocks and legs fixed to the couch by three wide canvas straps and the arms folded across the chest.
|
4th Week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Syed Shakil ur Rehman, Riphah International University
- Principal Investigator: Anum Anwar, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ledford C. Spine Conditions: Mechanical and Inflammatory Low Back Pain. FP Essent. 2017 Oct;461:15-20.
- Chien JJ, Bajwa ZH. What is mechanical back pain and how best to treat it? Curr Pain Headache Rep. 2008 Dec;12(6):406-11. doi: 10.1007/s11916-008-0069-3.
- Urits I, Burshtein A, Sharma M, Testa L, Gold PA, Orhurhu V, Viswanath O, Jones MR, Sidransky MA, Spektor B, Kaye AD. Low Back Pain, a Comprehensive Review: Pathophysiology, Diagnosis, and Treatment. Curr Pain Headache Rep. 2019 Mar 11;23(3):23. doi: 10.1007/s11916-019-0757-1.
- Hooten WM, Cohen SP. Evaluation and Treatment of Low Back Pain: A Clinically Focused Review for Primary Care Specialists. Mayo Clin Proc. 2015 Dec;90(12):1699-718. doi: 10.1016/j.mayocp.2015.10.009.
- AAP Council on Communications and Media. Virtual Violence. Pediatrics. 2016;138(1):e20161298. Pediatrics. 2016 Oct;138(4):e20162399. doi: 10.1542/peds.2016-2399. No abstract available.
- Rodriguez-Fuentes I, De Toro FJ, Rodriguez-Fuentes G, de Oliveira IM, Meijide-Failde R, Fuentes-Boquete IM. Myofascial Release Therapy in the Treatment of Occupational Mechanical Neck Pain: A Randomized Parallel Group Study. Am J Phys Med Rehabil. 2016 Jul;95(7):507-15. doi: 10.1097/PHM.0000000000000425.
- Tantanatip A, Chang K-V. Myofascial Pain Syndrome. 2018.
- Sharan D, Rajkumar JS, Mohandoss M, Ranganathan R. Myofascial low back pain treatment. Curr Pain Headache Rep. 2014 Sep;18(9):449. doi: 10.1007/s11916-014-0449-9.
- Jorgensen K. Human trunk extensor muscles physiology and ergonomics. Acta Physiol Scand Suppl. 1997;637:1-58.
- Davis KG, Marras WS. The effects of motion on trunk biomechanics. Clin Biomech (Bristol, Avon). 2000 Dec;15(10):703-17. doi: 10.1016/s0268-0033(00)00035-8.
- Salvetti Mde G, Pimenta CA, Braga PE, McGillion M. Prevalence of fatigue and associated factors in chronic low back pain patients. Rev Lat Am Enfermagem. 2013 Jan-Feb;21 Spec No:12-9. doi: 10.1590/s0104-11692013000700003. English, Portuguese.
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)
February 20, 2022
Primary Completion (ACTUAL)
July 30, 2022
Study Completion (ACTUAL)
August 30, 2022
Study Registration Dates
First Submitted
February 20, 2022
First Submitted That Met QC Criteria
March 8, 2022
First Posted (ACTUAL)
March 9, 2022
Study Record Updates
Last Update Posted (ACTUAL)
October 19, 2022
Last Update Submitted That Met QC Criteria
October 17, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/ 22/0101 Anum
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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