Clinical trial NCT04860726: Myofascial Release and Joint Mobilization Therapy in Non-Specific Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Fascia
Range of motion
Ultrasonography
Low back pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ultrasonography for Muscle thickness
timeFrame: 1 month
measure: Pain Pressure Algometer
timeFrame: 1 month
measure: Digital Inclinometer for Range of motion
timeFrame: 1 month
Secondary outcomes:
measure: Numeric pain rating scale
timeFrame: 1 month
measure: Sit and Reach test
timeFrame: 1 month
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Al-Razi Healthcare
state: Punjab
city: Lahore
country: Pakistan
facility: Riphah Rehabilitation Centre
state: Punjab
Study officials:
affiliation: Riphah International University
name: Syed Shakil ur Rehman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah International University
name: Hafiz Muhammad Waseem Javaid, PhD*
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah International University
name: Muhammad Kashif, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah International University
name: Muhammad Salman Bashir, PhD
role: PRINCIPAL_INVESTIGATOR
References: