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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04860726
Recruitment Status : Recruiting
First Posted : April 27, 2021
Last Update Posted : June 2, 2022
Sponsor:
Information provided by (Responsible Party):
Riphah International University

Brief Summary:

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 participants and therapist providing treatment will not be blinded but the assessor and the biostatistician will be blinded. The outcome measure tools for data quantification will be used i.e. Diagnostic Ultrasound Scanner to measure lumbar multifidis 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.Sample size of 45 will be calculated using G. power software with 12% attrition rate. Patientswill 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.21.

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


Condition or disease Intervention/treatment Phase
Low Back Pain Other: Joint mobilization Other: Myofascial Release Other: Joint mobilization & Myofascial Release Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Myofascial Release and Joint Mobilization Therapy on Pain, Muscle Thickness, Range of Motion and Functional Disability in Non-Specific Low Back Pain
Actual Study Start Date : April 25, 2021
Estimated Primary Completion Date : October 30, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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



Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04860726


Contacts
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Contact: Muhammad Salman Bashir, PhD 00923334497959 salman.bashir@riphah.edu.pk
Contact: Hafiz Muhammad Waseem Javaid, Phd* 03005047143

Locations
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Pakistan
Al-Razi Healthcare Recruiting
Lahore, Punjab, Pakistan, 54000
Contact: Muhammad Salman Bashir, PhD    00923334497959    salman.bashir@riphah.edu.pk   
Principal Investigator: Wasim Javaid, PhD*         
Riphah Rehabilitation Centre Recruiting
Lahore, Punjab, Pakistan
Contact: Salman Bashir, PhD         
Principal Investigator: Wasim Javaid, PhD         
Shalamar Hospital Recruiting
Lahore, Punjab, Pakistan
Contact: Salman Bashir, PhD         
Principal Investigator: Waseem Javaid, PhD*         
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Muhammad Salman Bashir, PhD Riphah International University
Publications:

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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT04860726    
Other Study ID Numbers: Rec/Lhr/1104
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: June 2, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riphah International University:
Fascia
Range of motion
Ultrasonography
Low back pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations