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New treatment option for Chronic Low Back Pain (CLBP)
Official title Neuroimmune Responses to Exercise in Chronic Back Pain
ClinicalTrials.gov ID: NCT07497425
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- -CLBP patients:
- Have a diagnosis of chronic primary LBP, according to the criteria established by NIH Task Force on Research Standards for CLBP (Deyo et al., 2015)...
- Report a CLBP intensity of at least 4 in a 0-10 numerical rating scale (0 = no pain, 10 = maximum possible pain). -Healthy controls: \- Be over 18...
You likely can't join if
- -CLBP patients:
- Present any red flags indicative of serious pathology comorbid or as the cause of CLBP (Finucane et al., 2020);
- Have a CLBP phenotype characterized by predominant nociceptive (as in fracture, infection, malignancy, inflammatory or rheumatic spondyloarthropathy...
- Present chronic or acute pain of higher intensity or perceived disability in any other body site than the low back;
- Medical history of diabetes, neurological or psychiatric disorder;
- Presence of significant cardiorespiratory problems or any other potential contraindications to physical exercise as assessed through the Physical...
See the full eligibility criteria
- -CLBP patients:
- Have a diagnosis of chronic primary LBP, according to the criteria established by NIH Task Force on Research Standards for CLBP (Deyo et al., 2015). This will be determined by 1) the response to the National Institutes...
- Report a CLBP intensity of at least 4 in a 0-10 numerical rating scale (0 = no pain, 10 = maximum possible pain). -Healthy controls: \- Be over 18 years and under 75 years of age;
- -CLBP patients:
- Present any red flags indicative of serious pathology comorbid or as the cause of CLBP (Finucane et al., 2020);
- Have a CLBP phenotype characterized by predominant nociceptive (as in fracture, infection, malignancy, inflammatory or rheumatic spondyloarthropathy, cauda equina syndrome, confirmed by MRI when suspected) or...
- Present chronic or acute pain of higher intensity or perceived disability in any other body site than the low back;
- Medical history of diabetes, neurological or psychiatric disorder;
- Presence of significant cardiorespiratory problems or any other potential contraindications to physical exercise as assessed through the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+);
- Following a regular structured PE training program (\>60 min/week) at study's onset, and;
- Presence of any contraindications to MRI examination (including any metallic implants or devices, being pregnant, and claustrophobia). Exclusion criteria-Healthy controls:
- Have symptoms or a diagnosis of any acute or chronic pain conditions;
- Medical history of diabetes, neurological or psychiatric disorder;
- Presence of significant cardiorespiratory problems or any other potential contraindications to physical exercise as assessed through the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+);
- Following a regular structured PE training program (\>60 min/week) at study's onset, and;
- Presence of any contraindications to MRI examination (including any metallic implants or devices, being pregnant, and claustrophobia).
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.