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

Primary Purpose

Low Back Pain, Muscle Atrophy, Diagnostic Imaging

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Targeted exercise program

General exercise program

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain; paraspinal muscle; exercise; diagnostic imaging; randomized controlled trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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°)

Sites / Locations

PERFORM Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Targeted exercise program

General exercise program

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Change in lumbar extensor muscle strength

lumbar extensor muscle strength will be assessed using a MedX Lumbar Isokinetic Dynamometer.

Full Information

NCT ID

NCT04257253

First Posted

January 27, 2020

Last Updated

March 31, 2023

Sponsor

Concordia University, Montreal

1. Study Identification

Unique Protocol Identification Number

NCT04257253

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

October 13, 2021 (Actual)

Study Completion Date

January 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Concordia University, Montreal

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Targeted exercise program

Arm Type

Experimental

Arm Description

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

Arm Title

General exercise program

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Targeted exercise program

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

General exercise program

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in multifidus muscle size (cross-sectional area)

Description

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

Time Frame

Baseline, 6-week, 12-week

Title

Change in multifidus muscle fatty infiltration

Description

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

Time Frame

Baseline, 6-week, 12-week

Secondary Outcome Measure Information:

Title

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

Description

Time Frame