Myofascial Release and Joint Mobilization Therapy in Non-Specific Low Back Pain

February 10, 2025 updated by: Riphah International University

Effects of Myofascial Release and Joint Mobilization Therapy on Pain, Muscle Thickness, Range of Motion and Functional Disability in Non-Specific Low Back Pain

Low back pain is a common condition affecting many individuals at some point in their lives. The prevalence of Non-specific low back pain (LBP) is between 4.2% and 19.6%, which is responsible for high treatment costs, sick leave, and individual suffering, in addition to being one of the main reasons for people to seek health care services. LBP prevalence increases linearly from the third decade of life on, until the 60 years of age, being more prevalent in women. This trial will be a prospective, parallel, double blinded, randomized, interventional clinical trial (comparing Myofascial Release and Joint Mobilization therapy). The patients will be screened by researcher and randomly allocated into either experimental groups. After recruitment, the person will be contacted for allocation so that randomization will be secured and concealed. The outcome measure tools for data quantification will be used i.e. Diagnostic Ultrasound Scanner to measure lumbar multifidus and transversus abdominis muscle thickness, pain pressure algometer to measure pain pressure sensitivity and Halo-digital inclinometer to measure range of motion of the lumbar region. A pilot study was done on a sample of 30 with 10 participants in each group. A sample of 84 participants (28 participants in each group) with an attrition rate of 12%, level of significance 5%, margin of error 20% was the output. Patients will be randomly allocated in 3 groups (Group A, Joint mobilization: Group B, Myofascial Release: Group C, both joint mobilization and myofascial release: Common treatment, Heating for 15 minutes). Each group will receive 4 sessions of treatment in 2 weeks' period on Day 1st day 4th, day 8th and day 12th.Data will be collected on Day 1st; Pre and post-treatment, Day 4th, Day 8th,Day 12th; post treatment and after 1 month. Data will be analyzed with SPSS version.26.

Study will be conducted in Al-Razi Healthcare and Riphah Rehabilitation Centre, Lahore, Pakistan. The duration of study will be 18 months after the approval of synopsis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

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

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Al-Razi Healthcare
      • Lahore, Punjab, Pakistan
        • Riphah Rehabilitation Centre

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 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients between the ages of 20 to 50 years for non-specific low back pain diagnosed by researcher according to the non-specific low back pain criteria comprising of history and physical examination. Physical examination should be done in different positions as follows

    • Inspect the back for deformities e.g. stooping forward
    • Palpate for muscle guarding, trigger points
    • Lumbar excursion and range of motion
    • Gait
    • Heel and Toe Walking (Inability to walk on heels alone or toes alone signifies significant muscle weakness) • Hip joint range of motion
    • FABER test (Flexion, Abduction and External Rotation)
    • Straight Leg Raising Test (SLR)
    • Cross SLR
    • Neurological examination • Palpate for muscle guarding, trigger points
    • Femoral Extension Test • Straight Leg Raising Test (SLR)
  • Both male and female patients will be recruited.
  • Patient diagnosis based on clinical assessment and duration of pain.
  • People who have not received physical therapy application or exercise regimen for the past 3 months
  • Patients suffering with low back pain for less than 3 months. Severity of Pain should be 3 to 7 on NPRS will be included in the study.
  • Patients not received analgesics and Non-steroidal anti-inflammatory drugs for previous 1 week.

Exclusion Criteria:

  • Patients already diagnosed with any systemic or musculoskeletal pathology e.g. vasculogenic, viscerogenic, neurogenic Low back pain or any history of any recent trauma etc.
  • Patients having as severe to extreme findings of low back pain reflecting the patient irritable.
  • Any previous surgery or epidural injection treatment or nerve block in the lumbosacral region.
  • Females who are pregnant or any recent pregnancy in past 6 months
  • Any sensory or motor deficit in the lower extremities.
  • Any signs of reg flags; i.e. tumors, constitutional symptoms, integumentary issues, cauda equina syndromes etc. will be excluded.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GROUP A
Joint mobilization
Other: Joint mobilization
Maitland Mobilization GIII and GIV i. PA Central and unilateral vertebral pressure ii.Transverse vertebral pressure iii. heating pad for 15 minutes
Experimental: GROUP B
Myofascial release
Other: Myofascial Release

Myofascial release is a hands-on soft tissue technique that facilitates a stretch into the restricted fascia. A sustained pressure is applied into the restricted tissue barrier; after 90-120 seconds the tissue will undergo histological length changes allowing the first release to be felt. The therapist will follow the release into a new tissue barrier and holds. After a few releases the tissue will become softer and more pliable.

The middle point of the Lateral raphae of the Thoracolumbarfascia between the posterior musculofascial junction of the Transversus Abdominis will be identified by ultrasonography. Vertical manual pressure will be applied on the middle point of the thoracolumbarfascia for 1 min ii. heating pad for 15 minutes
Experimental: GROUP C
Joint Mobilization & Myofascial release
Other: Joint mobilization & Myofascial Release

Maitland Mobilization GIII and GIV i. PA Central and unilateral vertebral pressure ii.Transverse vertebral pressure iii. heating pad for 15 minutes iv. Myofascial release is a hands-on soft tissue technique that facilitates a stretch into the restricted fascia. A sustained pressure is applied into the restricted tissue barrier; after 90-120 seconds the tissue will undergo histological length changes allowing the first release to be felt. The therapist will follow the release into a new tissue barrier and holds. After a few releases the tissue will become softer and more pliable.

The middle point of the Lateral raphae of the Thoracolumbarfascia between the posterior musculofascial junction of the Transversus Abdominis will be identified by ultrasonography. Vertical manual pressure will be applied on the middle point of the thoracolumbarfascia for 1 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasonography for Muscle thickness
Time Frame: 1 month
Interpretation will be done according to the images received after ultrasonography. Readings will be done 1st day, 4th,8th,12th,and after one month.
1 month
Pain Pressure Algometer
Time Frame: 1 month
Pai threshold will be measured by applying pain pressure algometer and readings will be measured.Readings will be done 1st day, 4th,8th,12th,and after one month.
1 month
Digital Inclinometer for Range of motion
Time Frame: 1 month

Instrument used for Range of motion.Readings will be done 1st day, 4th,8th,12th,and after one month.

Normal Ranges: FLEXION : 0-60, EXTENSION: 0-25, LATERAL FLEXION: 0-25, ROTATION :0-18
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric pain rating scale
Time Frame: 1 month
0= no pain 10 = worse pain Readings will be done 1st day, 4th,8th,12th,and after one month.
1 month
Sit and Reach test
Time Frame: 1 month
Excellent: >34-26 cm Good= 34-26 cm Above average: 32-23 Average: 29-20 Below average: 26-17 cm Poor: 23-14 cm V poor: < 21- <12 cm Readings will be done 1st day, 4th,8th,12th,and after one month.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Muhammad Salman Bashir, PhD, Riphah International University
  • Principal Investigator: Syed Shakil ur Rehman, PhD, Riphah International University
  • Principal Investigator: Hafiz Muhammad Waseem Javaid, PhD*, Riphah International University
  • Principal Investigator: Muhammad Kashif, PhD, 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

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)

April 25, 2021

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

April 22, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (Actual)

April 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rec/Lhr/1104 Waseem

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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