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

Effect of a Supervised Exercise Program on Paraspinal Muscle Morphology and Function in Patients With Chronic Low Back Pain: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Muscle Atrophy; Diagnostic Imaging; Exercise Therapy
• Intervention / Treatment: Other: Targeted exercise program; Other: General exercise program

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4B1R6
      • PERFORM Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Targeted exercise program; Targeted motor control and isolated lumbar extensor strengthening exercises. Supervised 12-week program, 2 times a week.	Other: Targeted exercise program; 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.
Active Comparator: General exercise program; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in12-item Short Form Health Survey (SF-12)	The 12-item Short Form Health Survey (SF-12) is the condensed form of the previous 36-item Short Form Health Survey and is used to assess health-related quality of life.The 12-item survey consists of 8 domains that assess both physical and mental health composite scores (PCS and MCS). While the SF-12 is weighted and summed to provide an interpretable scale for both the PCS and MCS. The score of the 12 questions can range from 0 (worst level of health) to 100 (highest level of health).	Baseline, 6-week, 12-week, 24-week
Change in Oswestry Low Back Pain Disability Index (ODI)	The ODI is used to measure the patient's level of disability in relation to LBP. It is a 10-item scale in which each item is rated from 0-6. Higher scores are indicative of greater disability.	Baseline, 6-week, 12-week, 24-week
Change in The International Physical Activity Questionnaire (IPAQ)	The IPAQ is a self-reported log of metabolic equivalent (MET)-minutes per week. The level of physical activity is rated either vigorous, moderate, walking and sitting and must be assigned to the right category. The number of minutes per category is then added up and assessed.	Baseline, 6-week, 12-week, 24-week
Change in Tampa Scale of Kinesiophobia (TSK)	The TSK measures pain-related fear in an individual through a 13-item scale. The scores range between 17 and 68 with increasing scores indicating a greater level of kinesiophobia.	Baseline, 6-week, 12-week, 24-week
Change in Visual Numerical pain rating scale (NPR)	The NRP for pain is a rating system from 0 to 10 with 0 being no pain and 10 worst pain imaginable.	Baseline, 6-week, 12-week, 24-week
Change in The Pain Catastrophizing Scale (PCS)	The PCS is a 13-item questionnaire that assesses the participant's level of catastrophizing. Each item is rated from 0-4 for a possible total of 52. The higher the score, the greater the level of catastrophizing.	Baseline, 6-week, 12-week, 24-week
Change in The Hospital Anxiety and Depression Scale (HADS)	The HADS is a 14-item questionnaire used to assess a patient's level of depression and anxiety. Each item is rated from 0-3 with either depression or anxiety having scores between 0 and 21, with 21 being the highest level possible.	Baseline, 6-week, 12-week, 24-week
Change in Insomnia Severity Index (ISI)	The ISI is a 7-item questionnaire used to assess sleep disturbances. Each item is rated from 0 to 4 and the total score is added. The higher the score, the greater the level of sleep disturbances.	Baseline, 6-week, 12-week, 24-week
Change in paraspinal muscle size (cross-sectional area)	Paraspinal 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 paraspinal muscle fatty infiltration	Paraspinal muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI) from L1 to L5 spinal levels.	Baseline, 6-week, 12-week
Change in multifidus muscle function (% thickness change)	Multifidus muscle function, expressed as the % thickness change from a rested to contracted position via contralateral arm lifts will be assessed by ultrasound.	Baseline, 6-week, 12-week
Change in lumbar extensor muscle strength	lumbar extensor muscle strength will be assessed using a MedX Lumbar Isokinetic Dynamometer.	Baseline, 6-week, 12-week

Collaborators and Investigators

• Sponsor: Concordia University, Montreal

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): October 13, 2021
• Study Completion (Actual): January 11, 2022

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 26, 2025
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: low back pain; paraspinal muscle; exercise; diagnostic imaging; randomized controlled trial
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Back Pain; Low Back Pain; Muscular Atrophy
• Other Study ID Numbers: CCER19-20-09

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
• product manufactured in and exported from the U.S.: No