Status:
RECRUITING
The METRIC Study Protocol
Lead Sponsor:
Université du Québec à Trois-Rivières
Conditions:
Chronic Low-back Pain
Eligibility:
All Genders
18-60 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 planning to get pregnant in the next 12 months;
- History of spinal manipulative therapy in the past 12 months;
- Scoliosis ≥ 20°;
- BMI ≥ 40;
- Insufficient language skills in French to complete the questionnaires;
- Open or pending litigation for LBP or seeking/receiving disability compensation;
- Diagnosis of an illness affecting the sensorimotor functions e.g., diabetes, multiple sclerosis, amyotrophic lateral sclerosis;
- Diagnosis of mental health disorders (with the exception of anxiety and depression);
- Current drug or alcohol dependence;
- Skin of type I on the Fitzpatrick scale;
- (For healthy volunteers only) Regular use of pain medication or usage in the 48 h prior to data collection;
- (For healthy volunteers only) History of chronic pain;
- (For healthy volunteers only) Acute pain on the days of data collection.
Key Trial Info
Start Date :
October 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT05986370
Start Date
October 25 2023
End Date
December 31 2026
Last Update
December 4 2023
Active Locations (1)
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1
Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, Canada, G8Z 4M3