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Recruiting NCT05986370

The METRIC Study Protocol

Trial Parameters

Condition Chronic Low-back Pain
Sponsor Université du Québec à Trois-Rivières
Study Type INTERVENTIONAL
Phase N/A
Enrollment 112
Sex ALL
Min Age 18 Years
Max Age 60 Years
Start Date 2023-10-25
Completion 2025-09-29
Interventions
lumbar spinal manipulative therapysham spinal manipulative therapyfull spine spinal manipulative therapy

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Duration of current low back pain (LBP) episode ≥ 6 months; * Average LBP 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. Exclusion Criteria: * Diagnosis of back conditions other than chronic primary LBP e.g., failed back surgery syndrome, spondylosis, spondylolisthesis, spinal stenosis, herniated disc, infection, etc.; * Presence of pain in another body location that is more severe than the pain in the lower back; * Presence of a neurological deficit i.e., sensation loss, muscle weakness, decreased deep tendon reflexes; * Presence of contraindications to spinal manipulative therapy e.g., recent fracture, history of spinal surgery, cauda equina syndrome, inflammatory arthritis, taking anticoagulant medication, active cancer, moderate to severe osteoporosis, abdominal aortic aneurysm; * Underwent surgery in the last 3 months; * Pregnancy, ≤ 3 months post-partum or

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