Actively Recruiting
The METRIC Study Protocol
Led by Université du Québec à Trois-Rivières · Updated on 2023-12-04
112
Participants Needed
1
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to test the effects of spinal manipulative therapy in individuals with chronic primary low back pain and determine the neurophysiological mechanisms underlying pain relief. The main questions it aims to answer are: • Is pain relief produced by spinal manipulative therapy in patients with chronic primary low back pain caused by a reduction of C-fiber-related nociceptive processing? • Are these effects greater when spinal manipulative therapy is applied to the whole spine where it is clinically indicated compared with lumbar spine only? • Are these effects greater after 36 treatments over 3 months compared with 12 treatments over 1 month. Participants will receive spinal manipulative therapy (all clinically indicated spine segments or back only) or a control intervention. A group of healthy volunteers will be recruited to assess secondary outcome measures over the same time period, as reference data for comparisons. Researchers will compare the two groups receiving spinal manipulative therapy to the group receiving the control intervention to see if clinical pain relief and the reduction of temporal summation of second pain (produced experimentally) is significantly greater with spinal manipulative therapy.
CONDITIONS
Official Title
The METRIC Study Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Duration of current low back pain episode 6 months
- Average low back pain intensity during the last 7 days 3/10
- For healthy volunteers only: to be of the same sex and age ( 1 year) as a participant with low back pain
You will not qualify if you...
- Diagnosis of back conditions other than chronic primary low back pain (e.g., failed back surgery syndrome, spondylosis, spondylolisthesis, spinal stenosis, herniated disc, infection)
- Pain in another body location more severe than lower back pain
- Neurological deficits such as sensation loss, muscle weakness, or decreased reflexes
- Contraindications to spinal manipulative therapy (e.g., recent fracture, spinal surgery history, cauda equina syndrome, inflammatory arthritis, anticoagulant use, active cancer, moderate to severe osteoporosis, abdominal aortic aneurysm)
- Surgery within the last 3 months
- Pregnancy, 3 months postpartum, or planning pregnancy within 12 months
- History of spinal manipulative therapy in the past 12 months
- Scoliosis 20
- BMI 40
- Insufficient French language skills to complete questionnaires
- Open or pending litigation for low back pain or seeking/receiving disability compensation
- Illness affecting sensorimotor functions (e.g., diabetes, multiple sclerosis, amyotrophic lateral sclerosis)
- Mental health disorders except anxiety and depression
- Current drug or alcohol dependence
- Skin type I on the Fitzpatrick scale
- For healthy volunteers only: regular pain medication use or use within 48 hours before data collection
- For healthy volunteers only: history of chronic pain
- For healthy volunteers only: acute pain on data collection days
AI-Screening
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Trial Site Locations
Total: 1 location
1
Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, Canada, G8Z 4M3
Actively Recruiting
Research Team
B
Benjamin Provencher
CONTACT
M
Mathieu Piché
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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