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

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 Overview

• Status: Unknown
• Conditions: Low Back Pain, Mechanical
• Intervention / Treatment: Other: mobilization; Other: manual therapy; Other: instrumental manual therapy

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Eastern
    • Khobar, Eastern, Saudi Arabia, 31911
      • Recruiting
      • Imam Abdulrahman Bin Faisal University
      • Contact: Qassem Almuaidi, Dean; Phone Number: +966550033666; Email: qmuaidi@iau.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 59 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: mobilization; central postroanterion mobilization on the most painful vertebral level at the lumbar spine; Other: manual therapy; manual therapy
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.	Other: mobilization; central postroanterion mobilization on the most painful vertebral level at the lumbar spine; Other: instrumental manual therapy; instrumental manual therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure pain threshold	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	2-3 weeks
Lumbar spine ROM	measured in flexion, extension, and lateral flexion to both sides. Dual inclinometer method used to take the measurements (Baseline Bubble Inclinometer device)	2-3 weeks

Collaborators and Investigators

• Sponsor: Imam Abdulrahman Bin Faisal University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): December 30, 2020
• Study Completion (ANTICIPATED): April 30, 2021

Study Registration Dates

• First Submitted: April 26, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (ACTUAL): April 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IRB-PGS-2018-03-286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No