Spinal Manipulation and Mindfulness-Based Stress Reduction for Chronic Lower Back Pain

Not currently recruiting at 1 trial location

Overseen By John Burns, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Rush University Medical Center

Must not be taking: Opioids, Corticosteroids

Disqualifiers: Substance abuse, Psychotic disorders, Fibromyalgia, Osteoporosis, others

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

Compensation: Varies

Number of Visits: 15

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to manage chronic lower back pain without opioids, which can cause serious side effects and lead to addiction. Researchers are testing two treatments: mindfulness therapy, a mental practice focusing on presence and stress reduction, and spinal manipulation therapy, a physical treatment using hands-on techniques to relieve pain. The goal is to assess how these therapies affect the body's natural pain control system. Individuals with significant daily lower back pain for at least three months who do not regularly use opioids might be suitable for this study. As an Early Phase 1 trial, this research aims to understand how these treatments work in people, offering participants a chance to contribute to groundbreaking pain management strategies.

Will I have to stop taking my current medications?

The trial requires that you do not use opioid painkillers daily or within 3 days of each lab session. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both mindfulness-based stress reduction therapy (MT) and spinal manipulation therapy (SMT) are generally safe for people.

For MT, studies indicate it can reduce pain and improve movement in those with long-term low back pain. A review found that MT leads to short-term improvements in pain levels compared to usual care, with minimal risk of harm, indicating it is well-tolerated.

SMT also has a good safety record. Research has found SMT to be as safe as other recommended treatments for long-term low back pain. One study noted that 12 sessions of SMT led to significant pain relief without serious side effects, demonstrating SMT as a safe option for managing pain.

Both treatments have been studied and found to be safe and effective in reducing long-term low back pain, indicating they are generally well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for chronic lower back pain because they combine non-drug approaches that could offer relief without the side effects of medications like opioids or NSAIDs. Spinal Manipulation Therapy (SMT) involves hands-on techniques by physical therapists to adjust the spine, potentially providing pain relief by improving spinal function. Mindfulness-Based Stress Reduction Therapy (MT) uses mindfulness practices to help patients manage pain perception and reduce stress, which can contribute to overall well-being. Both approaches focus on holistic care, targeting not just the physical symptoms but also the mental aspects of chronic pain, offering a comprehensive alternative to standard pain management options.

What evidence suggests that this trial's treatments could be effective for chronic lower back pain?

This trial will compare Mindfulness-Based Stress Reduction (MBSR) therapy and Spinal Manipulation Therapy (SMT) for chronic lower back pain. Studies have shown that MBSR can improve movement and reduce pain over time, with benefits observed at both 8 weeks and 6 months. Research also indicates that MBSR can enhance overall quality of life and mental health for those dealing with chronic pain. Similarly, SMT matches the effectiveness of other recommended treatments for chronic spine pain, offering similar benefits in reducing pain and improving movement. Overall, both MBSR and SMT have shown promise in effectively managing chronic lower back pain. ^{6 7 8 9 10}

Who Is on the Research Team?

John Burns, PhD

Principal Investigator

Rush University Medical Center

Stephen Bruehl, PhD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with chronic low back pain, who experience significant daily pain and interference in daily activities. Participants must not be on opioids, have intact cognitive abilities, and be able to consent and complete questionnaires in English. Exclusions include severe health conditions like osteoporosis, recent lumbar surgery, high BMI (40+), certain mental health issues, substance abuse problems, or specific other pain conditions.

Inclusion Criteria

I don't use opioid painkillers daily or 3 days before lab tests.

I have had significant daily pain for at least 3 months that affects my daily activities.

I am mentally capable of understanding and agreeing to the study.

Exclusion Criteria

I cannot hold my breath for 15 seconds.

You have a spinal cord stimulator or pump inserted in your back.

I have been using corticosteroids for a long time.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Participants undergo 2 laboratory pain-induction sessions before randomization

1 week

2 visits (in-person)

Treatment

Participants receive 8 weeks of SMT or MT treatment with placebo/naloxone administration

8 weeks

8 visits (in-person)

Post-treatment

Participants undergo 2 laboratory pain-induction sessions after treatment

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Based Stress Reduction Therapy (MT)
• Spinal Manipulation Therapy (SMT)

Trial Overview

The study tests the effectiveness of Mindfulness Based Stress Reduction Therapy (MT) and Spinal Manipulation Therapy (SMT) against a placebo in reducing chronic lower back pain without relying on long-term opioid use. It will also examine changes in the body's own opioid function before and after treatment.

How Is the Trial Designed?

Group I: SMT plus placebo/naloxone Experimental Treatment 3 Interventions

Participants are randomly assigned to an 8 week SMT treatment group conducted by certified physical therapists. Immediately before and after the treatment sessions along with midway through the treatment (after 4 sessions), participants will undergo the placebo/naloxone administration intervention to assess mechanisms of SMT or MT-related changes.

Group II: MT plus placebo/naloxone Experimental Treatment 3 Interventions

Participants are randomly assigned to an 8 week MT treatment group conducted by certified clinical therapists. Immediately before and after the treatment sessions along with midway through the treatment (after 4 sessions), participants will undergo the placebo/naloxone administration intervention to assess mechanisms of SMT or MT-related changes.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Published Research Related to This Trial

A survey of 118 primary care providers (PCPs) revealed that 70.1% were familiar with Mindfulness-Based Stress Reduction (MBSR), and 59.0% referred patients to MBSR at least once a year, indicating a significant awareness and utilization of this non-pharmacological treatment for chronic low back pain.

Collaboration between PCPs and mindfulness instructors was limited, with only 16.3% of referring PCPs reporting such collaboration, suggesting a need for improved communication and education to enhance patient access to MBSR programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Interprofessional Collaboration and Referral to Mindfulness-Based Stress Reduction Programs. Binda, DD., Weinberg, JM., Nguyen, T., et al.[2023]

Spinal manipulative therapy (SMT) can lead to serious complications, with vertebrobasilar accidents (VBAs) being the most common, occurring primarily after cervical manipulations with a rotatory component, with an estimated risk ranging from 1 in 20,000 to 1 in 1 million treatments.

Cauda equina syndrome (CES) is a rare complication of SMT, estimated to occur in less than 1 in 1 million treatments, and most complications can be avoided by screening patients for contraindications before treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of spinal manipulation: a comprehensive review of the literature. Assendelft, WJ., Bouter, LM., Knipschild, PG.[2022]

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 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]

Mindfulness-based stress reduction (MBSR) techniques significantly improve subjective pain scores and quality of life in chronic pain patients, particularly those with chronic low back pain, based on a review of 12 empirical studies.

Despite some limitations such as small sample sizes and varied pain measurement tools, the evidence suggests that MBSR can be an effective non-pharmacological treatment option for managing chronic pain and enhancing mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Mindfulness Practices for Improving Outcomes in Chronic Low Back Pain. Smith, SL., Langen, WH.[2022]

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]

In a study involving 104 patients with chronic low back pain, combining spinal manipulative therapy (SMT) with pain neuroscience education (PNE) did not show immediate benefits in reducing pain intensity or disability compared to SMT alone.

However, the combination of SMT and PNE resulted in longer-lasting improvements in pain intensity and disability at 90 and 180 days, suggesting that PNE may enhance the effectiveness of SMT over time, potentially through increased pain self-efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Additional effect of pain neuroscience education to spinal manipulative therapy on pain and disability for patients with chronic low back pain: a randomized controlled trial. Tavares, FAG., Rossiter, JVA., Lima, GCL., et al.[2023]

A systematic review of three randomized controlled trials involving 117 patients with chronic low back pain found that mindfulness-based stress reduction (MBSR) showed significant short-term improvements in pain intensity and disability for patients with failed back surgery syndrome, but not for older adults with chronic low back pain.

Overall, the evidence for MBSR's effectiveness in improving pain intensity or disability in chronic low back pain is inconclusive, although there is some indication that it may help improve pain acceptance. Further research with larger sample sizes and better control conditions is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for low back pain. A systematic review. Cramer, H., Haller, H., Lauche, R., et al.[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]

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