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Online Physical Exercise for Chronic Lower Back Pain (CLBPEO Trial)

N/A

Waitlist Available

Led By Mathieu Roy, PhD

Research Sponsored by Mathieu Roy

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of chronic low back pain, lasting for more than 6 months

Be older than 18 years old

Must not have

Presentation of neuropathic signs (radiating pain that spreads to the knee and leg)

Being under 18 years of age or over 80 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed before each of the 36 training sessions

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how web-based tools can help people with chronic low back pain. 45 people will be randomly split into 3 groups to compare effectiveness. Pain intensity will be measured at 0 & 12 weeks.

Who is the study for?

This trial is for adults with chronic low back pain lasting over 6 months who have internet and a device like a computer with webcam or tablet. They must be able to follow an online exercise program. It's not for those under 18, over 80, or with psychiatric/neurological illnesses, or neuropathic signs like radiating leg pain.

What is being tested?

The study tests two web-based physical exercise programs for chronic low back pain: one interactive and one using pre-recorded videos. Participants are split into three groups randomly, including a control group without these exercises, to compare the effects after 12 weeks.

What are the potential side effects?

Since this trial involves physical exercises done via an online platform, potential side effects may include muscle soreness or strain from the activities. However, serious side effects are unlikely given the non-invasive nature of the interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had chronic low back pain for over 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I experience pain that spreads from my hip to my knee and leg.

Select...

I am either younger than 18 or older than 80.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed after each of the 36 training sessions

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed after each of the 36 training sessions

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed after each of the 36 training sessions for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline low back pain intensity at 12 weeks

Secondary study objectives

Baseline low back pain-related lawsuits and legal claims

Change from baseline Body Mass Index group at 12 weeks

Change from baseline Gait Speed test score at 12 weeks

+40 more

Other study objectives

Pain intensity after each session

Pain intensity before each training session

Pain intensity during the performance of physical tests at baseline

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: VideoExperimental Treatment1 Intervention

The sessions will be done individually without interaction via pre-recorded videos. The videos demonstrate specific classes provided to the patients in this arm by a kinesiologist. Participants will be able to contact the kinesiologist by phone or email to ask questions about the sessions. The sessions will last 1h30min.

Group II: InteractiveExperimental Treatment1 Intervention

The sessions will be given in groups of 5 to 10 people and will be interactive via Zoom (link will be sent to them by email). They will last 1h30min and will consist of 60min of physical activity, preceded and followed by 15 optional minutes of virtual social interaction with the kinesiologist and the other members of the group. Finally, if the participants are unable to attend the group session, a video of the course given will be available for them to follow afterwards via a website.

Group III: ControlActive Control1 Intervention

The control will be instructed to continue their lifestyle habits throughout the study. These participants will not receive any intervention until their outcome measures at baseline and follow-up are recorded. At this point their participation is completed and they will be offered one of the two physical exercise programs. Therefore, this arm will be acting like a waitlist group.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Interactive physical exercise

2020

N/A

~60

Video physical exercise

2020

N/A

~60