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

NCT ID: NCT04257253

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-01-11

Brief Summary

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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.

Detailed Description

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Conditions

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Low Back Pain Muscle Atrophy Diagnostic Imaging Exercise Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Targeted exercise program

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

Group Type EXPERIMENTAL

Targeted exercise program

Intervention Type 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.

General exercise program

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

Group Type ACTIVE_COMPARATOR

General exercise program

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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°)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Concordia University, Montreal

OTHER

Sponsor Role lead

Responsible Party

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Maryse Fortin

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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PERFORM Centre

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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CCER19-20-09

Identifier Type: -

Identifier Source: org_study_id

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