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Online Physical Exercise for Chronic Lower Back Pain (CLBPEO Trial)
N/A
Recruiting
Led By Mathieu Roy, PhD
Research Sponsored by McGill University
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
CLBPEO Trial 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.Check my eligibility
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.See study design
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.
CLBPEO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had chronic low back pain for over 6 months.
CLBPEO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline low back pain intensity at 12 weeks
Secondary outcome measures
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 moreOther outcome measures
Pain intensity after each session
Pain intensity before each training session
Pain intensity during the performance of physical tests at baseline
+2 moreCLBPEO 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.
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Who is running the clinical trial?
Université du Québec a MontréalOTHER
22 Previous Clinical Trials
5,242 Total Patients Enrolled
Université de MontréalOTHER
214 Previous Clinical Trials
102,726 Total Patients Enrolled
Institut Universitaire de Gériatrie de MontréalOTHER
2 Previous Clinical Trials
75 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had chronic low back pain for over 6 months.I experience pain that spreads from my hip to my knee and leg.You have a history of mental or brain-related illness.You can participate in a physical activity program and fill out a questionnaire about your physical activity.I am either younger than 18 or older than 80.
Research Study Groups:
This trial has the following groups:- Group 1: Video
- Group 2: Interactive
- Group 3: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many study participants is the trial accommodating at maximum capacity?
"Yes, the information visible on clinicaltrials.gov affirms that this medical research is still actively enrolling participants. Initially posted June 1st 2020 and last updated June 6th 2023, the trial seeks 45 volunteers at 2 locations."
Answered by AI
Are researchers still accepting participants for this experiment?
"According to pertinent records found on clinicaltrials.gov, this trial is currently in search of participants with the first posting date being June 1st 2020 and most recently updated on June 6th 2023."
Answered by AI
Will adults who are over the age of 35 be considered for participation in this clinical trial?
"This clinical trial is accepting individuals aged 18 or older but under 80."
Answered by AI
What stipulations must prospective participants of this trial meet?
"For enrolment in the trial, patients must possess chronic lower back pain and fall within the 18 to 80 age range. In total, 45 people are being recruited for participation."
Answered by AI
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