60 Participants Needed

Adaptive Walking Intervention for Chronic Pain in Opioid Use Disorder

RR
Overseen ByR. Ross MacLean, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: VA Office of Research and Development
Must be taking: Buprenorphine, Methadone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on a stable dose of opioid agonist treatment (like buprenorphine or methadone) for at least two weeks before joining the study.

What data supports the effectiveness of the treatment for chronic pain in opioid use disorder?

Research suggests that exercise can help people with opioid use disorder by improving brain health, sleep, and overall quality of life, while also reducing anxiety, depression, and pain. This indicates that physical activity, like the adaptive walking program, may be a useful addition to treatment for managing chronic pain in these patients.12345

Is the adaptive walking intervention safe for humans?

Research shows that the walking program, when used as part of therapy for chronic pain, is generally safe for humans. Most adverse events (unwanted effects) reported were minor and temporary.678910

How is the Steps 2 Change treatment different from other treatments for chronic pain in opioid use disorder?

Steps 2 Change is unique because it combines a pedometer-assisted walking program with adaptive goals to increase physical activity, specifically targeting individuals with chronic pain who use opioids. This approach emphasizes gradual increases in daily steps, which can help manage pain and reduce reliance on opioids, unlike traditional treatments that may not focus on physical activity as a primary component.6891011

What is the purpose of this trial?

This trial tests a walking program with pain education for Veterans with chronic pain and opioid use disorder. The goal is to help manage their pain by teaching them about it and encouraging more physical activity. Participants will use pedometers to track their steps and attend regular sessions. Pedometer-driven walking programs have been previously studied for their feasibility and effectiveness in managing chronic pain and increasing physical activity.

Research Team

RR

R. Ross MacLean, PhD

Principal Investigator

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Eligibility Criteria

This trial is for Veterans with chronic pain and opioid use disorder (OUD) who are currently on a stable dose of opioid agonist treatment. Participants must be able to walk, have access to a mobile phone with data, and experience pain that limits activity or enjoyment. Those with untreated major psychiatric disorders, planned surgeries for pain, active suicidal thoughts, or current CBT for pain cannot join.

Inclusion Criteria

I can walk at least one block by myself.
I am on a stable dose of opioid addiction treatment and meet the criteria for opioid use disorder.
Access to a mobile phone with active data plan
See 1 more

Exclusion Criteria

You have a serious untreated mental health condition like bipolar disorder or psychotic disorder.
I am currently undergoing cognitive behavioral therapy for chronic pain.
I am scheduled for surgery to manage my pain.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly 60-minute treatment sessions over four consecutive weeks, focusing on pain education and an adaptive walking program.

4 weeks
4 visits (in-person)

Follow-up

Participants are monitored for pain interference and other outcomes using ecological momentary assessment (EMA) at 3-month and 6-month intervals.

6 months

Treatment Details

Interventions

  • Control
  • Health Education
  • Steps 2 Change (S2C)
Trial Overview The study tests a non-drug intervention called Steps 2 Change (S2C), which includes education about managing pain and an adaptive walking program using pedometers. The goal is to see if this can help manage chronic pain in Veterans receiving treatment for OUD without relying on more opioids.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Steps 2 Change (S2C)Experimental Treatment1 Intervention
Participants randomized to S2C will be scheduled for 60-minute weekly treatment sessions held over four consecutive weeks in the outpatient OAT clinic. Veterans will be expected to increase their average step counts by 10% over their prior week's average starting after Session 1. Session 1 will provide pain education including a discussion the biopsychosocial treatment model for chronic pain and benefits of activity. Session 2 and 3 will emphasize benefits of low impact physical activity and introduce activity pacing to address pain flare ups caused by cycles of over activity and subsequent sedentary behavior. Session 4 will help develop a treatment plan to continue walking and identify possible barriers to meeting goals.
Group II: ControlActive Control1 Intervention
Participants randomized to control will be scheduled for 60-minute weekly treatment sessions held over four consecutive weeks focused on problems associated with MOUD, substance use, and general self-management strategies. Importantly, group will explicitly avoid talking about pain coping skills and setting goals for daily step targets.

Steps 2 Change (S2C) is already approved in United States for the following indications:

🇺🇸
Approved in United States as Steps to Change for:
  • Chronic Pain Management in Veterans with Opioid Use Disorder

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Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Findings from Research

In a study of 298 detoxification patients over six months, higher baseline pain levels were linked to worse psychiatric and medical outcomes, highlighting the negative impact of chronic pain on recovery.
Regular exercise at baseline was associated with improved psychiatric severity and greater abstinence self-efficacy, particularly benefiting those with less intense pain, suggesting that exercise can be a valuable part of treatment for detoxification patients.
Health outcomes among detoxification patients: The role of chronic pain.Woodhead, EL., Brief, D., Below, M., et al.[2021]
Exercise interventions for individuals with opioid use disorder (OUD) have shown positive effects on immune function, pain reduction, cravings, anxiety, depression, mood, and overall quality of life, based on a review of 13 studies.
While exercise is considered an acceptable and feasible adjunct treatment for OUD, most studies involved small sample sizes, highlighting the need for further research with larger groups to confirm these benefits.
Physical activity and exercise interventions for individuals with opioid use disorder: a scoping review.Shreffler, J., Genova, G., Huecker, M.[2022]
A study involving 23 patients with opioid use disorder (OUD) showed that wearable accelerometry can effectively detect restlessness related to opioid withdrawal, providing a new way to quantify withdrawal symptoms objectively.
The analysis revealed a strong correlation between specific movement patterns detected by accelerometry and the severity of withdrawal symptoms, suggesting that this technology could be used in outpatient settings to monitor and manage withdrawal more effectively.
Leveraging Accelerometry as a Prognostic Indicator for Increase in Opioid Withdrawal Symptoms.Lambert, TP., Gazi, AH., Harrison, AB., et al.[2023]

References

Health outcomes among detoxification patients: The role of chronic pain. [2021]
Physical activity and exercise interventions for individuals with opioid use disorder: a scoping review. [2022]
Leveraging Accelerometry as a Prognostic Indicator for Increase in Opioid Withdrawal Symptoms. [2023]
Assessing the feasibility, usability and acceptability of the MySafeRx platform among individuals in outpatient buprenorphine treatment: Lessons learned from a pilot randomized controlled trial. [2023]
Comprehensive treatment for patients with chronic pain in a 12-step based substance use disorder program. [2019]
Opioid use and walking among patients with chronic low back pain. [2016]
The feasibility and acceptability of a physical activity intervention for older people with chronic musculoskeletal pain: The iPOPP pilot trial protocol. [2021]
Short-term effect of a chronic pain self-management intervention delivered by an easily accessible primary healthcare service: a randomised controlled trial. [2020]
Reliability and validity of the PAD questionnaire: a measure to assess pain-related decline in physical activity. [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
Incorporating walking into cognitive behavioral therapy for chronic pain: safety and effectiveness of a personalized walking intervention. [2023]
A qualitative investigation of activity measurement and change following a mind-body activity program for chronic pain. [2022]
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