Comparative Effectiveness of Positional Release technique and Instrument Assisted Soft Tissue Mobilization on Pain, Lumbar range of motion and Function in Chronic Mechanical Low Back Pain

**1.**Background:

Chronic mechanical LBP originates from the anatomical structures of spine, intervertebral discs, and surrounding soft tissues and persists for >12 weeks.The global prevalence of chronic low back pain is substantial, with up to 23% of the population affected, and frequent episode of recurrences. Various manual therapy techniques such as Positional Release Therapy (PRT), Instrument Assisted Soft Tissue Mobilization (IASTM), Muscle Energy Technique (MET) and Myofascial Release (MFR), are utilized in the management of Chronic Mechanical Low Back Pain. IASTM and PRT both have shown significant effect on pain and range of motion in individuals with Chronic Mechanical Low Pain.

2. OBJECTIVES

Primary objectives

•       To determine the effect of Positional Release Technique and Instrument Assisted Soft Tissue Mobilization on pain reduction.

•       To determine the effect of Positional Release Technique and Instrument Assisted Soft Tissue Mobilization on Lumbar Range of Motion.

•       To determine the effect of Positional Release Technique and Instrument Assisted Soft Tissue Mobilization on functional disability.

3. HYPOTHESIS

Null Hypothesis Ho-

•    There will be no significant difference in Positional Release Technique and Instrument Assisted Soft Tissue Mobilization on reduction in pain, functional disability and improving lumbar ROM in Chronic Mechanical Low Back Pain.

Alternate Hypothesis H1-

•   There will be significant difference in Positional Release Technique and Instrument Assisted Soft Tissue Mobilization on reduction in pain, functional disability and improving lumbar ROM in Chronic Mechanical Low Back Pain.

4. Material and Methods

This randomized controlled trial will be conducted on Chronic mechanical low back patients experiencing chronic low back pain, recruited from the Indian Spinal Injury Centre, New Delhi. A total of 24 participants (12 in each group) will be included based on strict inclusion and exclusion criteria. Eligible individuals will be aged 18–50 years, diagnosed with chronic mechanical low back pain and suffering from mild to moderate low back pain (VAS-3 to 6) for more than 3 months. Participants with history of trauma or surgery, diagnosed with neurological disorder, spinal causes, systemic disease and skin conditions like petechiae, ecchymosis, allergy to metal and emollients.

Baseline assessments will cover pain (Visual Analogue Scale), Lumbar ROM (Android/ iOS App) and Functional disability (Oswestry Disability Index). Participants will be randomly assigned into two experiments (PRT + conventional therapy) and (IASTM + conventional therapy). The intervention will be conducted for 35 minutes per session, three times a week for three weeks. Post-intervention assessments will follow the same outcome measures.

Group A: PRT + Conventional Physiotherapy

The patient is asked to lie on his tummy. The examiner palpates the painful points on the lateral aspect of the transverse processes from L1 to L5. The examiner then side bends and raises the hip while applying pressure to the painful point. This position is maintained for 90 seconds. The process is repeated for 2–3 repetitions for each movement, with a total duration of 15 minutes. Hot pack and back exercises will be provided in Conventional physiotherapy.

Group B: IASTM + Conventional Physiotherapy

The patient is asked to lie on his tummy; lubricant (Oil) will be applied to the lower back area to facilitate smooth gliding of the IASTM tool (Graston) which is made of stainless steel, allows therapists to apply pressure to painful areas in muscles, helping to relieve pain and improve movement. The intervention will begin with light to moderate pressure, ensuring that the patient experiences only mild discomfort without pain. IASTM will be applied for approximately 90–120 seconds on each muscle, followed by 1 minute of rest after each muscle, with the instrument held at a 45° angle. The total treatment duration will be about 15 minutes. In the remaining days, hot pack and back exercises will be given as part of the conventional physiotherapy.

5.  Statistical Analysis Plan:

Data will be analyzed using SPSS v21.0. Normality will be tested with the Shapiro-Wilk test. Paired t-test or Wilcoxon test will be used for within-group comparisons, and independent t-test or Mann–Whitney U test for between-group comparisons.