NCT04367376

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

Status unknown NA Last updated 29 April 2020

What this trial tests

NA trial testing mobilization in Low Back Pain, Mechanical in 40 participants. Status unknown.

Timeline

1 June 2020

Primary endpoint
30 December 2020

30 April 2021

Quick facts

Lead sponsor	Imam Abdulrahman Bin Faisal University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	1 June 2020
Primary completion	30 December 2020
Estimated completion	30 April 2021
Sites	1 location across Saudi Arabia

Drugs / interventions tested

• mobilization
• manual therapy
• instrumental manual therapy

Conditions studied

• Low Back Pain, Mechanical — all drugs for Low Back Pain, Mechanical →

Sponsor

Imam Abdulrahman Bin Faisal University

Who can join

Adults 20 to 59, any sex, with Low Back Pain, Mechanical. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.