The METRIC Study Protocol (METRIC)
Chronic Low-back Pain
About this trial
This is an interventional treatment trial for Chronic Low-back Pain focused on measuring chronic primary low back pain, spinal manipulative therapy, nociplastic pain, central sensitization, C-fibers, brain, electroencephalography
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Sham Comparator
No Intervention
lumbar spinal manipulative therapy
full spine spinal manipulative therapy
sham spinal manipulative therapy
no intervention
Participants will receive spinal manipulative therapy (SMT) exclusively at dysfunctional lumbar segments. Participants will receive 36 SMT sessions over 12 weeks, 3 times per week, each session lasting ≈15 min. Spinal manipulation will be performed using the diversified technique. For each treatment, the SMT provider will perform two spinal manipulations, one on each side of the most painful lumbar vertebra. During spinal manipulations, participants will lay on their side and they will be instructed to inhale and exhale fully before each thrust.
Participants will receive spinal manipulative therapy (SMT) at dysfunctional spinal segments in the lumbar AND other spine regions. Participants will receive 36 spinal manipulative therapy (SMT) sessions over 12 weeks, 3 times per week, each session lasting ≈15 min. Spinal manipulation will be performed using the diversified technique. For each treatment, the SMT provider will perform a minimum of two spinal manipulations, one on each side of the most painful lumbar vertebra. Spinal manipulation will also be delivered at other dysfunctional spinal segments, based on clinical examination. During spinal manipulations, participants will lay prone, supine or on their side and they will be instructed to inhale and exhale fully before each thrust.
Participants will receive 36 sham SMT sessions (3x/week for 12 weeks, each session ≈15 min). This will target dysfunctional segments in the lumbar and other spine regions. Three maneuvers will be used: Ventral decubitus: 1 to 5 light and brief manual contacts (≈ 20 N and 5 s) will be applied and quickly released over the spinous process of dysfunctional vertebrae identified during clinical examination. Dorsal decubitus: sections of the treatment table will be slightly raised or lowered (≈ 5 cm) and their lower limbs' position changed once or twice e.g., knees bent, hips internally or externally rotated. Each position maintained during ≈ 30 s. Lateral decubitus: 1 to 5 impulses at the lowest setting of the Activator V instrument (Activator Methods Int. Ltd., Phoenix, Arizona, USA) will be applied on their gluteus and quadratus lumborum muscles. The position of the instrument will change after each impulse.
This fourth arm will comprise healthy volunteers (age/sex-matched to the participants in the test intervention - lumbar group) who will not receive any intervention. The main purpose of this fourth group is to provide reference values to interpret some results obtained in participants with chronic primary low back pain.