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

Low Back Pain, Mechanical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04367376
• Other study ID #: IRB-PGS-2018-03-286
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: April 2020
• Source: Imam Abdulrahman Bin Faisal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 59 Years

Eligibility

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).

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Mechanical

Intervention

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

Locations

Country	Name	City	State
Saudi Arabia	Imam Abdulrahman Bin Faisal University	Khobar	Eastern

Sponsors (1)

Lead Sponsor	Collaborator
Imam Abdulrahman Bin Faisal University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Lumbar Multifidus muscle activation	muscle activation quantified by measuring the muscle thickness during rest and activation positions.	2-3 weeks
Secondary	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
Secondary	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