Effect of a Supervised Exercise Program in Patients With Chronic Low Back Pain

NCT04257253 | Completed

• 1 other identifier: CCER19-20-09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect of a supervised exercise program on paraspinal muscle morphology and function, as well as disability/function in patients with non-specific chronic low back pain. Half of the participants will do a targeted paraspinal muscle exercise program, while the other half will do a general exercise program.

Conditions

Low Back Pain; Muscle Atrophy; Diagnostic Imaging; Exercise Therapy

Keywords

low back pain; paraspinal muscle; exercise; diagnostic imaging; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Change in multifidus muscle size (cross-sectional area)

  Multifidus muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI) from L1 to L5 spinal levels.

  Baseline, 6-week, 12-week

• Change in multifidus muscle fatty infiltration

  Multifidus muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI) from L1 to L5 spinal levels.

  Baseline, 6-week, 12-week

Secondary Outcomes (12)

• Change in12-item Short Form Health Survey (SF-12)

  Baseline, 6-week, 12-week, 24-week

• Change in Oswestry Low Back Pain Disability Index (ODI)

  Baseline, 6-week, 12-week, 24-week

• Change in The International Physical Activity Questionnaire (IPAQ)

  Baseline, 6-week, 12-week, 24-week

• Change in Tampa Scale of Kinesiophobia (TSK)

  Baseline, 6-week, 12-week, 24-week

• Change in Visual Numerical pain rating scale (NPR)

  Baseline, 6-week, 12-week, 24-week

Study Arms (2)

Targeted exercise program

EXPERIMENTAL

Targeted motor control and isolated lumbar extensor strengthening exercises. Supervised 12-week program, 2 times a week.

Other: Targeted exercise program

General exercise program

ACTIVE COMPARATOR

General exercise program including upper body and lower body strengthening and flexibility exercises. Supervised 12-week program, 2 times a week.

Other: General exercise program

Interventions

Targeted exercise program OTHER

Participants in this experimental intervention group will perform a combination of motor control and isolated lumbar extensor strenghtening exercises. The level of difficulty of the exercises will be progressed gradually. The intervention will last 12 weeks, and each participant will have 2 supervised exercise sessions per week.

Targeted exercise program

General exercise program OTHER

Participants in this active intervention group will perform a generalized exercise program comprising upper-body and lower-body and hip strengthening exercises, as well as flexibility. The level of difficulty of the exercises will be progressed gradually. The intervention will last 12 weeks, and each participant will have 2 supervised exercise sessions per week.

General exercise program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic nonspecific LBP (\>3 months), defined as pain in the region between the lower ribs and gluteal folds, with or without leg pain
• currently seeking care for LBP
• between 18 and 60 years of age
• English or French speaker
• score of "moderate" or "severe" disability on the ODI questionnaire
• do not currently engage in sports or fitness training specifically for the lower back muscles (3 months prior the beginning of the study).

You may not qualify if:

• evidence of nerve root compression or reflex motor signs deficits (e.g. weakness, reflex changes, or sensory loss with same spinal nerve)
• previous spinal surgery or vertebral fractures
• other major lumbar spine structural abnormalities (e.g. spondylolysis, spondylolisthesis, or lumbar scoliosis \>10°)

Sponsors & Collaborators

• Concordia University, Montreal: lead

Study Sites (1)

PERFORM Centre

Montreal, Quebec, H4B1R6, Canada

Location

MeSH Terms

Conditions

Low Back Pain; Muscular Atrophy; Motor Activity

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 5, 2020
• Study Start: December 1, 2020
• Primary Completion: October 13, 2021
• Study Completion: January 11, 2022
• Last Updated: July 1, 2025

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)