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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.

Awards & highlights

METRIC Trial 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.Check my eligibility

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).See study design

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.

METRIC Trial 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.

METRIC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

low back pain intensity

temporal summation of second pain

Secondary outcome measures

Anxiety

Back performance scale (BPS)

C-fiber-related brain responses

+11 more

Other outcome measures

Adverse events (AE)

Blinding

Number of other treatments for low back pain

METRIC 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

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Who is running the clinical trial?

Université du Québec à Trois-RivièresLead Sponsor

43 Previous Clinical Trials

4,321 Total Patients Enrolled

Mathieu PichéPrincipal InvestigatorUniversité du Québec à Trois-Rivières

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 55 or more being enrolled for this research?

"As stated in the inclusion requirements, those hoping to take part must be between 18 and 60 years old."

Answered by AI

Are there eligibility criteria that would permit my involvement in this trial?

"For this clinical trial, 112 individuals experiencing chronic lower back pain and aged 18 to 60 will be recruited. Eligibility criteria include a longstanding episode of low back pain (LBP) lasting at least 6 months; an average LBP intensity rate of 3/10 or more in the last 7 days; for healthy volunteers only: being approximately the same age and sex as participants with low back pain."

Answered by AI

Is there a recruitment drive underway for this clinical experiment?

"Affirmative. Clinicaltrials.gov provides evidence that this medical trial is actively recruiting, having first been posted on October 25th 2023 and updated for the last time December 1st of the same year. 112 participants are sought from a single site."

Answered by AI

How many individuals are signing up to take part in this research project?

"Affirmative. Clinicaltrials.gov indicates that the recruitment process for this clinical study has been active since October 25th 2023 and was last updated on December 1st 2023. 112 patients are needed to be enrolled from a single medical facility."

Answered by AI

What are the core aims that this experiment seeks to achieve?

"This clinical trial will assess the primary outcome of low back pain intensity over a predetermined baseline, 4- and 12-week postrandomization time frame. Secondary outcomes include frequency/duration derived from an adapted version of the Pain Frequency-Severity-Duration Scale as well as catastrophizing associated with fear avoidance models, along with Pressure Pain Thresholds measured via digital algometer at three separate body locations."

Answered by AI

Recent research and studies

The Spine JournalJournal

Dose-response and Efficacy of Spinal Manipulation for Care of Chronic Low Back Pain: A Randomized Controlled Trial

Haas, Mitchell, Darcy Vavrek, David Peterson, Nayak Polissar, and Moni B. Neradilek. 2014. “Dose-response and Efficacy of Spinal Manipulation for Care of Chronic Low Back Pain: A Randomized Controlled Trial”. The Spine Journal. Elsevier BV. doi:10.1016/j.spinee.2013.07.468.

Applied Nursing ResearchJournal

Methods to Measure Peripheral and Central Sensitization Using Quantitative Sensory Testing: A Focus on Individuals with Low Back Pain

Starkweather, Angela R., Amy Heineman, Shannon Storey, Gil Rubia, Debra E. Lyon, Joel Greenspan, and Susan G. Dorsey. 2016. “Methods to Measure Peripheral and Central Sensitization Using Quantitative Sensory Testing: A Focus on Individuals with Low Back Pain”. Applied Nursing Research. Elsevier BV. doi:10.1016/j.apnr.2015.03.013.

clinicaltrials.govStudy

The METRIC Study Protocol

Mathieu Piché 2023. "The METRIC Study Protocol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05986370.

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