NCT05272098

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

February 20, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

February 20, 2022

Last Update Submit

October 17, 2022

Conditions

Keywords

Mechanical low back painmyofascial releaseendurance trainingNPRS

Outcome Measures

Primary Outcomes (3)

  • NPRS (numeric pain rating scale)

    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

    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

    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

Study Arms (2)

Group A

EXPERIMENTAL

myofascial release therapy

Other: Group A will receive myofascial release therapy + conventional physical therapy

Group B

ACTIVE COMPARATOR

endurance training of the trunk extensor muscles

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

Interventions

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 A

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.

Group B

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • History of mechanical low back pain
  • Back pain without association with leg pain

You may not qualify if:

  • Any bony, soft tissue or systemic disease
  • Pregnant females
  • Radiculopathy
  • Patient with spinal deformities and fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alkhaliq hospital Nishtar road

Multan, Punjab Province, 60000, Pakistan

Location

Related Publications (11)

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

    PMID: 29019640BACKGROUND
  • 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.

    PMID: 18973732BACKGROUND
  • 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.

    PMID: 30854609BACKGROUND
  • 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.

    PMID: 26653300BACKGROUND
  • 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.

    PMID: 27940893BACKGROUND
  • 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.

    PMID: 26745225BACKGROUND
  • Tantanatip A, Chang K-V. Myofascial Pain Syndrome. 2018.

    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.

    PMID: 25091133BACKGROUND
  • Jorgensen K. Human trunk extensor muscles physiology and ergonomics. Acta Physiol Scand Suppl. 1997;637:1-58.

    PMID: 9246395BACKGROUND
  • 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.

    PMID: 11050352BACKGROUND
  • 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.

    PMID: 23459886BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Syed Shakil ur Rehman

    Riphah International University

    STUDY CHAIR
  • Anum Anwar

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2022

First Posted

March 9, 2022

Study Start

February 20, 2022

Primary Completion

July 30, 2022

Study Completion

August 30, 2022

Last Updated

October 19, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations