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

NCT04860726 | Completed DMC

• 1 other identifier: Rec/Lhr/1104 Waseem
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Low Back Pain

Keywords

Fascia; Range of motion; Ultrasonography; Low back pain

Outcome Measures

Primary Outcomes (3)

• Ultrasonography for Muscle thickness

  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

  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

  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 Outcomes (2)

• Numeric pain rating scale

  1 month

• Sit and Reach test

  1 month

Study Arms (3)

GROUP A

EXPERIMENTAL

Joint mobilization

Other: Joint mobilization

GROUP B

EXPERIMENTAL

Myofascial release

Other: Myofascial Release

GROUP C

EXPERIMENTAL

Joint Mobilization \& Myofascial release

Other: Joint mobilization & Myofascial Release

Interventions

Joint mobilization OTHER

Maitland Mobilization GIII and GIV i. PA Central and unilateral vertebral pressure ii.Transverse vertebral pressure iii. heating pad for 15 minutes

GROUP A

Myofascial Release OTHER

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

GROUP B

Joint mobilization & Myofascial Release OTHER

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

GROUP C

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (2)

Al-Razi Healthcare

Lahore, Punjab Province, 54000, Pakistan

Location

Riphah Rehabilitation Centre

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Muhammad Salman Bashir, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: April 25, 2021
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)