Effects of Myofascial Release Therapy and Endurance Training on Mechanical Back Pain

NCT ID: NCT05272098

Last Updated: 2022-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-20

Study Completion Date

2022-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Back Pain, Low

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

myofascial release therapy

Group Type EXPERIMENTAL

Group A will receive myofascial release therapy + conventional physical therapy

Intervention Type OTHER

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.

Group B

endurance training of the trunk extensor muscles

Group Type ACTIVE_COMPARATOR

Group B will receive endurance training of the trunk extensor muscles + conventional physical therapy

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Group A will receive myofascial release therapy + conventional physical 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.

Intervention Type OTHER

Group B will receive endurance training of the trunk extensor muscles + conventional physical therapy

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Syed Shakil ur Rehman

Role: STUDY_CHAIR

Riphah International University

Anum Anwar

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alkhaliq hospital Nishtar road

Multan, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

Ledford C. Spine Conditions: Mechanical and Inflammatory Low Back Pain. FP Essent. 2017 Oct;461:15-20.

Reference Type BACKGROUND
PMID: 29019640 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18973732 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30854609 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26653300 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27940893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26745225 (View on PubMed)

Tantanatip A, Chang K-V. Myofascial Pain Syndrome. 2018.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 25091133 (View on PubMed)

Jorgensen K. Human trunk extensor muscles physiology and ergonomics. Acta Physiol Scand Suppl. 1997;637:1-58.

Reference Type BACKGROUND
PMID: 9246395 (View on PubMed)

Davis KG, Marras WS. The effects of motion on trunk biomechanics. Clin Biomech (Bristol). 2000 Dec;15(10):703-17. doi: 10.1016/s0268-0033(00)00035-8.

Reference Type BACKGROUND
PMID: 11050352 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23459886 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/RCR & AHS/ 22/0101 Anum

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.