The METRIC Study Protocol

NCT05986370 | Recruiting

• 1 other identifier: METRIC
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

chronic primary low back pain; spinal manipulative therapy; nociplastic pain; central sensitization; C-fibers; brain; electroencephalography

Outcome Measures

Primary Outcomes (2)

• low back pain intensity

  In accordance with recommendations for chronic pain trials, participants will be instructed to rate the intensity of their LBP using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable). As in the brief pain inventory (BPI), they will be instructed to rate their pain: 1) right now; 2) on average over the last 7 days; 3) at its worst over the last 7 days; 4) at its best over the last 7 days.

  baseline, 1- , 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-, 11-, 12-, 26-, 39-, 52- and 64-weeks post-randomization.

• temporal summation of second pain

  Participants will receive a total of 160 painful laser stimuli, 80 single-pulse stimuli and 80 pulse trains (3 pulses delivered at 0.67 Hz). After each stimulus, participants will be prompted to rate second pain with the display of a numerical pain rating scale. The pain ratings of single pulses will be subtracted from the pain ratings of pulse trains to estimate the intensity of the temporal summation of second pain.

  baseline, 4- and 12-weeks post-randomization.

Secondary Outcomes (14)

• low back pain frequency and duration

  baseline, 1- , 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-, 11-, 12-, 26-, 39-, 52- and 64-weeks post-randomization.

• Pressure pain thresholds (PPTs)

  baseline, 4- and 12-weeks post-randomization.

• C-fiber-related brain responses

  baseline, 4- and 12-weeks post-randomization.

• Oswestry Disability Index (ODI)

  baseline, 4-, 12-, 26-, 39-, 52- and 64-weeks post-randomization.

• Back performance scale (BPS)

  baseline, 4- and 12-weeks post-randomization.

Other Outcomes (3)

• Adverse events (AE)

  1- , 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-, 11-, 12-, 13-weeks post-randomization.

• Blinding

  After the last treatment session (12-weeks post-randomization)

• Number of other treatments for low back pain

  1- , 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-, 11-, 12-weeks post-randomization.

Study Arms (4)

lumbar spinal manipulative therapy

EXPERIMENTAL

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.

Procedure: lumbar spinal manipulative therapy

full spine spinal manipulative therapy

EXPERIMENTAL

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.

Procedure: full spine spinal manipulative therapy

sham spinal manipulative therapy

SHAM COMPARATOR

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.

Procedure: sham spinal manipulative therapy

no intervention

NO INTERVENTION

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.

Interventions

lumbar spinal manipulative therapy PROCEDURE

Spinal manipulative therapy involves the application of spinal manipulation over several sessions. Spinal manipulation is defined as a high-velocity, low-amplitude thrust performed by a clinician to move a segment of the spine in a specific direction. This type of intervention often generates cavitation sounds (audible pops).

Also known as: spinal manipulation, chiropractic adjustment, grade 5 spinal mobilization

lumbar spinal manipulative therapy

sham spinal manipulative therapy PROCEDURE

Sham spinal manipulative therapy (sham SMT), was designed to be structurally equivalent to SMT, i.e., to attend to the same body regions with the same amount of contact as well as to have the same number, frequency and length of sessions. SMT and sham SMT will be provided by the same treatment provider and will appear to be similarly tailored to the participants' condition. Sham SMT does not share the component of interest of SMT, i.e., the activation of deep high-threshold mechanoreceptors via high-velocity, low-amplitude thrusts applied to the spine. Yet, it shares all the other components not of interest in this study that may contribute to the placebo response, such as therapeutic alliance, contextual factors, physical touch, and expectations. Furthermore, deception will be used to balance expectations and enhance blinding.

Also known as: control intervention, sham control, sham treatment, placebo

sham spinal manipulative therapy

full spine spinal manipulative therapy PROCEDURE

Spinal manipulative therapy involves the application of spinal manipulation over several sessions. Spinal manipulation is defined as a high-velocity, low-amplitude thrust performed by a clinician to move a segment of the spine in a specific direction. This type of intervention often generates cavitation sounds (audible pops).

Also known as: spinal manipulation, chiropractic adjustment, grade 5 spinal mobilization

full spine spinal manipulative therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Université du Québec à Trois-Rivières: lead

Study Sites (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G8Z 4M3, Canada

RECRUITING

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MeSH Terms

Conditions

Nociplastic Pain

Interventions

Manipulation, Spinal; Manipulation, Chiropractic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation; Complementary Therapies

Study Officials

• Mathieu Piché

  Université du Québec à Trois-Rivières

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Provencher

CONTACT

1-819-376-5011; metric@uqtr.ca

Mathieu Piché

CONTACT

1-819-376-5011; metric@uqtr.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 14, 2023
• Study Start: October 25, 2023
• Primary Completion: September 29, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 4, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available upon publication of the results (expected in January 2026). They will be available for the next 5 years.

Locations

CA (1)