Spinal Manipulative Therapy for Chronic Back Pain

(METRIC Trial)

Overseen By Mathieu Piché

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Université du Québec à Trois-Rivières

Must not be taking: Anticoagulants

Disqualifiers: Neurological deficit, Recent surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 37

Duration: 12 weeks

112 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking anticoagulant medication, you may be excluded from participating.

What data supports the effectiveness of this treatment for chronic back pain?

Research shows that spinal manipulative therapy (SMT) can be effective for some patients with musculoskeletal pain, including chronic low back pain. However, the effectiveness compared to sham (fake) manipulations is still unclear, and results can vary depending on the specific techniques used. ^{1 2 3 4 5}

Is spinal manipulative therapy generally safe for humans?

Spinal manipulative therapy (SMT) is generally considered safe, with most patients experiencing mild and short-lived side effects. Serious side effects are rare, but more research is needed to better understand their frequency. ^{1 5 6 7 8}

How is spinal manipulative therapy different from other treatments for chronic back pain?

Spinal manipulative therapy (SMT) is unique because it involves manual techniques applied to the spine, aiming to provide mechanical and neurological benefits, which may offer short-term relief for chronic back pain. Unlike other treatments, SMT is often performed by chiropractors and focuses on manipulating the spine to alleviate pain. ^{1 2 3 4 9}

Research Team

Mathieu Piché

Principal Investigator

Université du Québec à Trois-Rivières

Eligibility Criteria

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.

Inclusion Criteria

I am the same age (± 1 year) and sex as someone with low back pain.

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive spinal manipulative therapy or sham therapy over 12 weeks, with 36 sessions in total

12 weeks

36 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

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

Treatment Details

Interventions

• Full Spine Spinal Manipulative Therapy
• Lumbar Spinal Manipulative Therapy
• Sham Spinal Manipulative Therapy

Trial Overview 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).

Participant Groups

Group I: lumbar spinal manipulative therapy Experimental Treatment 1 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 therapy Experimental Treatment 1 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 intervention Active Control 1 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 therapy Placebo Group 1 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.

Full Spine Spinal Manipulative Therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Spinal Manipulative Therapy for:

• Chronic low back pain

Approved in United States as Spinal Manipulative Therapy for:

• Chronic low back pain

Approved in Canada as Spinal Manipulative Therapy for:

• Chronic low back pain

Who Is Running the Clinical Trial?

Université du Québec à Trois-Rivières

Lead Sponsor

Trials

48

Recruited

4,500+

Findings from Research

Spinal manipulative therapy (SMT) shows similar effectiveness to recommended therapies for short-term pain relief in chronic low back pain, with a small improvement in functional status, based on a systematic review of 47 trials involving 9211 participants.

SMT is more effective than non-recommended therapies for improving function in the short term, and while most adverse events related to SMT are mild and transient, clinicians should inform patients about potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits and harms of spinal manipulative therapy for the treatment of chronic low back pain: systematic review and meta-analysis of randomised controlled trials. Rubinstein, SM., de Zoete, A., van Middelkoop, M., et al.[2022]

A systematic review of 19 randomized controlled trials involving 1080 adults found that manipulative therapy significantly reduces pain immediately after treatment, with a moderate effect size (SMD -0.68).

While manipulative therapy shows some effectiveness for pain relief in musculoskeletal disorders, it does not significantly impact disability or perceived recovery from asthma, and no serious adverse events were reported, indicating it is a relatively safe intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is manipulative therapy more effective than sham manipulation in adults : a systematic review and meta-analysis. Scholten-Peeters, GG., Thoomes, E., Konings, S., et al.[2022]

Thoracic spinal manipulative techniques (SMT) were found to significantly reduce temporal sensory summation (TSS) in healthy volunteers, suggesting a potential for regional pain modulation beyond the site of manipulation.

The study involved 90 healthy participants and indicated that while SMT may affect pain sensitivity, the long-term effects and relevance in clinical populations still require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate reduction in temporal sensory summation after thoracic spinal manipulation. Bishop, MD., Beneciuk, JM., George, SZ.[2021]

In a study involving 81 adults with chronic thoracic pain, spinal manipulative therapy (SMT) did not show significantly different outcomes compared to a control group that received no treatment, indicating that the specific biomechanical parameters of SMT may not influence clinical effects.

Despite the lack of significant differences between groups, participants did report decreases in pain intensity, disability, and spinal stiffness, suggesting that some benefits may still occur with SMT, but further research is needed to understand the underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of spinal manipulative therapy biomechanical parameters on clinical and biomechanical outcomes of participants with chronic thoracic pain: a randomized controlled experimental trial. Pagé, I., Descarreaux, M.[2020]

This systematic review analyzed 25 randomized, placebo-controlled trials of spinal manipulative therapy (SMT) and found that most studies used sham SMT procedures as placebos, but many had high or unclear risk of bias.

The review highlighted that many trials did not adequately assess subject blinding or ensure that placebos were truly inert, which could lead to skewed results and unreliable conclusions about the efficacy of SMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The quality of placebos used in randomized, controlled trials of lumbar and pelvic joint thrust manipulation-a systematic review. Puhl, AA., Reinhart, CJ., Doan, JB., et al.[2018]

A systematic review of 283 reviews on spinal manipulative therapy (SMT) found that while 46% deemed SMT safe, 13% considered it harmful, indicating a significant divide in opinions on its safety.

Serious adverse events (SAEs) associated with SMT, such as stroke and vertebral artery dissection, were reported, with incidence estimates ranging from 1 in 20,000 to 1 in 250,000,000 manipulations, highlighting that some risk is present.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The risk associated with spinal manipulation: an overview of reviews. Nielsen, SM., Tarp, S., Christensen, R., et al.[2022]

A cadaveric study involving six vertebral arteries showed that spinal manipulative therapy (SMT) caused strains to the vertebral artery that were significantly lower than the levels required for mechanical failure, suggesting a low risk of injury during typical SMT procedures.

The average strain on the vertebral artery during SMT was 6.2% for the distal loop and 2.1% for the proximal loop, which is about one ninth of the strain needed to cause mechanical disruption, indicating that SMT is likely safe under normal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internal forces sustained by the vertebral artery during spinal manipulative therapy. Symons, BP., Leonard, T., Herzog, W.[2019]

A systematic review of five studies on spinal manipulation (SM) found that about half of patients experience mild and transient adverse events after treatment, indicating that while side effects are common, they are generally not severe.

There is currently no reliable data on the incidence of serious adverse events related to spinal manipulation, suggesting that while they are likely rare, further research is needed to better understand their frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective investigations into the safety of spinal manipulation. Ernst, E.[2019]

Spinal manipulative therapy, primarily provided by chiropractors, has gained popularity in the U.S. for managing low back pain, spinal stenosis, and spondylolisthesis.

Randomized clinical trials suggest that spinal manipulation can offer short-term relief for patients, particularly those suffering from acute low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal manipulative therapy for low back pain. Swenson, R., Haldeman, S.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Benefits and harms of spinal manipulative therapy for the treatment of chronic low back pain: systematic review and meta-analysis of randomised controlled trials. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Is manipulative therapy more effective than sham manipulation in adults : a systematic review and meta-analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Immediate reduction in temporal sensory summation after thoracic spinal manipulation. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Effects of spinal manipulative therapy biomechanical parameters on clinical and biomechanical outcomes of participants with chronic thoracic pain: a randomized controlled experimental trial. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

The quality of placebos used in randomized, controlled trials of lumbar and pelvic joint thrust manipulation-a systematic review. [2018]

6. England pubmed.ncbi.nlm.nih.gov

The risk associated with spinal manipulation: an overview of reviews. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Internal forces sustained by the vertebral artery during spinal manipulative therapy. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Prospective investigations into the safety of spinal manipulation. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Spinal manipulative therapy for low back pain. [2019]