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

Not Applicable

• Conditions: Low Back Pain
• Interventions: Other: Joint mobilization & Myofascial Release; Other: Joint mobilization; Other: Myofascial Release

• Registration Number: NCT04860726
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-22
• Study First Submitted QC: 2021-04-22
• Study Start: 2021-04-25
• Study First Posted: 2021-04-27
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-31
• Last Update Posted: 2022-06-02
• Primary Completion: 2022-10-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP C	Joint mobilization & Myofascial Release	Joint Mobilization \& Myofascial release
GROUP A	Joint mobilization	Joint mobilization
GROUP B	Myofascial Release	Myofascial release

Primary Outcome Measures

Name	Time	Method
Pain Pressure Algometer	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.
Digital Inclinometer for Range of motion	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
Ultrasonography for Muscle thickness	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.

Secondary Outcome Measures

Name	Time	Method
Sit and Reach test	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.
Numeric pain rating scale	1 month	0= no pain 10 = worse pain Readings will be done 1st day, 4th,8th,12th,and after one month.

Trial Locations

Locations (3)

Al-Razi Healthcare; 🇵🇰 Lahore, Punjab, Pakistan

Shalamar Hospital; 🇵🇰 Lahore, Punjab, Pakistan

Riphah Rehabilitation Centre; 🇵🇰 Lahore, Punjab, Pakistan