The Short-term Effects of Instrument-Based Mobilization Compared With Manual Mobilization for Low Back Pain: A Randomized ClinicalTrial

Overview

Objectives: To investigate the effectiveness of instrument-based mobilization compared with manual mobilization in patients with non-specific low back pain (NLBP), in terms of spinal muscle activation, decrease in pain, and improvement in range of motion (ROM). Design: Randomized clinical trial, double blind. Participants and interventions: A total of 66 participants with localized NLBP will be divided into 2 groups matched for sex, age, and body mass index. The intervention group will receive central postero-anterior mobilization with a force of 150 N through physiotherapy instrument mobilization at the level of pain in the lumbar spine. The control group will receive central postero-anterior grade III mobilization through the pisiform grip method at the level of pain in the lumbar spine. Main outcome measures: Measurements will be taken before the intervention, after the 1st session, after the 6th session, and at 4 weeks follow-up. Rehabilitative ultrasound imaging will be done to identify lumbar multifidus (LM) activation through the measurement of muscle thickness at the level of L5-L4 vertebrae, during rest and lower-extremity movement. Each participant will self-rate the pain intensity in the lumbar spine according to the Numeric Pain Rating Scale (NPRS). The pressure-pain threshold (PPT) will be measured using an algometer. Lumbar ROM will be measured using a dual inclinometer method in flexion and extension. The results will be compared between the intervention and control groups through mixed analysis of variance for LM thickness, lumbar ROM, PPT, and NPRS.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 30, 2020

Interventions

  • Other: mobilization
    • central postroanterion mobilization on the most painful vertebral level at the lumbar spine
  • Other: manual therapy
    • manual therapy
  • Other: instrumental manual therapy
    • instrumental manual therapy

Arms, Groups and Cohorts

  • Experimental: manual therapy
    • The control group will receive central postero-anterior grade III mobilization through the pisiform grip method at the level of pain in the lumbar spine.
  • Experimental: instrumental manual therapy
    • the intervention groub rcieved central postero-anterior mobilization with a force of 20-30 N through physiotherapy instrument mobilization at the level of pain in the lumbar spine.

Clinical Trial Outcome Measures

Primary Measures

  • Numeric pain rating scale
    • Time Frame: 2-3 weeks
    • a series of numbers from 0 to 10, with ‘0’ indicating no pain and ’10’ indicating the most intense pain possible
  • Lumbar Multifidus muscle activation
    • Time Frame: 2-3 weeks
    • muscle activation quantified by measuring the muscle thickness during rest and activation positions.

Secondary Measures

  • Pressure pain threshold
    • Time Frame: 2-3 weeks
    • measured at the most painful site on the back as well as on a mid-point at RT tibialis anterior muscle belly lateral to the tibia
  • Lumbar spine ROM
    • Time Frame: 2-3 weeks
    • measured in flexion, extension, and lateral flexion to both sides. Dual inclinometer method used to take the measurements (Baseline Bubble Inclinometer device)

Participating in This Clinical Trial

Inclusion Criteria

  • age 20-59 years (commonly affected age range), BMI 18.5-30 kg/m2 (normal to overweight), localized NLBP, pain duration <12 months, and pain score ≥3/10 on the NPRS. Exclusion Criteria:

  • history of spinal surgery, significant previous back trauma, spinal or lower-extremity deformities, LBP associated with peripheral neurological symptoms (paraesthesia, anaesthesia, signs of nerve root compression), neurological diseases, systemic diseases (diabetes mellitus, rheumatoid arthritis), and any contraindication to manual therapy (spinal instability, healing fracture, dislocations, pregnancy in women).

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 59 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Imam Abdulrahman Bin Faisal University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Fadela Alqassab, Ms. – Imam Abdulrahman Bin Faisal University

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