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

NCT04367376 | Unknown

• 1 other identifier: IRB-PGS-2018-03-286
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain, Mechanical

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pressure pain threshold

  2-3 weeks

• Lumbar spine ROM

  2-3 weeks

Study Arms (2)

manual therapy

EXPERIMENTAL

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; Other: manual therapy

instrumental manual therapy

EXPERIMENTAL

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; Other: instrumental manual therapy

Interventions

mobilization OTHER

central postroanterion mobilization on the most painful vertebral level at the lumbar spine

instrumental manual therapy; manual therapy

manual therapy OTHER

manual therapy

manual therapy

instrumental manual therapy OTHER

instrumental manual therapy

instrumental manual therapy

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

Imam Abdulrahman Bin Faisal University

Khobar, Eastern Province, 31911, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ms.

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: April 29, 2020
• Study Start: June 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: April 30, 2021
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)