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Procedure

Spinal Manipulative Therapy for Chronic Back Pain (METRIC Trial)

N/A

Recruiting

Led By Mathieu Piché

Research Sponsored by Université du Québec à Trois-Rivières

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Duration of current low back pain (LBP) episode ≥ 6 months;

Average LBP intensity during the last 7 days ≥ 3/10;

Timeline

Screening 3 weeks

Treatment Varies

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

Summary

This trial tests the effects of spinal manipulation on chronic back pain and how it affects pain relief. It'll compare those who receive the treatment with those who don't to see if there's a difference.

Who is the study for?

This trial is for adults with chronic low back pain lasting at least 6 months and a recent pain intensity of 3/10 or more. Healthy volunteers must match the sex and age (±1 year) of a participant with low back pain.

What is being tested?

The study tests if spinal manipulative therapy reduces chronic lower back pain by affecting nerve-related pain processing. It compares full spine therapy to lumbar-only therapy, over different treatment durations (12 treatments in 1 month vs. 36 treatments in 3 months).

What are the potential side effects?

Spinal manipulative therapy may cause temporary discomfort, stiffness, or fatigue. Rarely, it might lead to increased pain or injury. The sham procedure should have minimal side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My current low back pain has lasted for 6 months or more.

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My average lower back pain in the last week was at least a 3 out of 10.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1- , 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-, 11-, 12-, 26-, 39-, 52- and 64-weeks post-randomization. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

low back pain intensity

temporal summation of second pain

Secondary study objectives

Anxiety

Back performance scale (BPS)

C-fiber-related brain responses

+11 more

Other study objectives

Adverse events (AE)

Blinding

Number of other treatments for low back pain

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: lumbar spinal manipulative therapyExperimental Treatment1 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.

Group II: full spine spinal manipulative therapyExperimental Treatment1 Intervention

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.

Group III: no interventionActive Control1 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.

Group IV: sham spinal manipulative therapyPlacebo Group1 Intervention

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.

0 / 2Eligibility criteria met