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

Primary Purpose

Back Pain, Low

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Group A will receive myofascial release therapy + conventional physical therapy
Group B will receive endurance training of the trunk extensor muscles + conventional physical therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain, Low focused on measuring Mechanical low back pain, myofascial release, endurance training, NPRS

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alkhaliq hospital Nishtar road

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

myofascial release therapy

endurance training of the trunk extensor muscles

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2022
Last Updated
October 17, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05272098
Brief Title
Effects of Myofascial Release Therapy and Endurance Training on Mechanical Back Pain
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 20, 2022 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Low
Keywords
Mechanical low back pain, myofascial release, endurance training, NPRS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
myofascial release therapy
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
endurance training of the trunk extensor muscles
Intervention Type
Other
Intervention Name(s)
Group A will receive myofascial release therapy + conventional physical therapy
Intervention Description
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
Intervention Name(s)
Group B will receive endurance training of the trunk extensor muscles + conventional physical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
NPRS (numeric pain rating scale)
Description
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.
Time Frame
4th week
Title
Rolland Morris Disability Questionnaire
Description
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.
Time Frame
4th Week
Title
Sorenson Test
Description
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.
Time Frame
4th Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Shakil ur Rehman
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anum Anwar
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alkhaliq hospital Nishtar road
City
Multan
State/Province
Punjab
ZIP/Postal Code
60000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29019640
Citation
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Results Reference
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PubMed Identifier
18973732
Citation
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.
Results Reference
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PubMed Identifier
30854609
Citation
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.
Results Reference
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PubMed Identifier
26653300
Citation
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.
Results Reference
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PubMed Identifier
27940893
Citation
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.
Results Reference
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PubMed Identifier
26745225
Citation
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.
Results Reference
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PubMed Identifier
29763057
Citation
Tantanatip A, Chang KV. Myofascial Pain Syndrome. 2023 Jul 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK499882/
Results Reference
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PubMed Identifier
25091133
Citation
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.
Results Reference
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PubMed Identifier
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Citation
Jorgensen K. Human trunk extensor muscles physiology and ergonomics. Acta Physiol Scand Suppl. 1997;637:1-58.
Results Reference
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PubMed Identifier
11050352
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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Effects of Myofascial Release Therapy and Endurance Training on Mechanical Back Pain

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