Physical Exercise for Chronic Lower Back Pain

(eCLBP Trial)

Overseen By Carlos Gevers Montoro, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGill University

Disqualifiers: Diabetes, Neurological, Psychiatric, Cardiorespiratory, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

216 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this mechanistic clinical trial is to learn how physical exercise affects the body and brain in people with chronic low back pain. The study will examine whether a 12-week online exercise program changes these measures compared with a waitlist group. Researchers will also study immune activity and brain function in people with chronic low back pain and compare them with healthy participants. Participants will complete questionnaires, provide blood samples, and undergo brain imaging scans.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with chronic primary low back pain.

My chronic low back pain is at least 4 out of 10 in intensity.

I am between 18 and 75 years old and in good health.

Exclusion Criteria

Healthy controls must not have significant cardiorespiratory problems or any other potential contraindications to physical exercise as assessed through PAR-Q+

Healthy controls must not be following a regular structured PE training program (>60 min/week) at study's onset

Healthy controls must not have any contraindications to MRI examination

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week online physical exercise program or are assigned to a waitlist control group. Healthy controls participate in the first 2 weeks of the exercise intervention.

12 weeks

Online sessions 3 times a week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain intensity, gene expression, and brain imaging.

4 weeks

Open-label extension (optional)

Participants in the waitlist group are offered access to the exercise program after completion of the study assessments.

What Are the Treatments Tested in This Trial?

Interventions

• Physical Exercise

How Is the Trial Designed?

Group I: Healthy controls Experimental Treatment 1 Intervention

Sex- and age-matched healthy volunteers will only participate in the first 2 weeks of PE intervention

Group II: Active intervention Experimental Treatment 1 Intervention

Physical Exercise Training

Group III: Waitlist Active Control 1 Intervention

Participants assigned to the waitlist group will not receive the physical exercise program during the 12-week intervention period but will continue their usual care. After completion of the study assessments, they will be offered access to the exercise program.

Who Is Running the Clinical Trial?

McGill University

Lead Sponsor

Trials

421

Recruited

1,017,000+