Testing spinal manipulative therapy for chronic low-back pain

The METRIC Study Protocol: an Explanatory Randomized Controlled Trial Investigating the Neurophysiological Mechanisms Underlying the Therapeutic Effects of Spinal Manipulative Therapy for Chronic Primary Low Back Pain

This study tests if spinal manipulative therapy can help people with chronic low back pain feel better and if different types of treatment make a difference.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 112 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Université du Québec à Trois-Rivières (other)
• Locations: 1 site (Trois-Rivières, Quebec)
• Trial ID: NCT05986370 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effects of spinal manipulative therapy on individuals suffering from chronic primary low back pain. It will investigate whether pain relief is linked to a reduction in C-fiber-related nociceptive processing and whether treatment outcomes differ based on the extent of spinal manipulation applied. Participants will receive either full spine or lumbar-only spinal manipulative therapy, or a control intervention, over varying treatment durations. Healthy volunteers will also be included to provide reference data for comparison.

Who should consider this trial

Good fit: Ideal candidates are individuals experiencing chronic primary low back pain for at least six months with moderate pain intensity.

Not a fit: Patients with other specific back conditions or severe pain in other body locations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective pain management strategies for patients with chronic low back pain.

How similar studies have performed: Previous studies have shown promising results with spinal manipulative therapy for similar conditions, suggesting potential for success in this approach.

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 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.

Where this trial is running

Trois-Rivières, Quebec

• Université du Québec à Trois-Rivières — Trois-Rivières, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Mathieu Piché — Université du Québec à Trois-Rivières
• Study coordinator: Benjamin Provencher

Conditions: Chronic Low-back Pain, chronic primary low back pain, spinal manipulative therapy, nociplastic pain, central sensitization, C-fibers, brain, electroencephalography