Adaptive Walking Intervention for Chronic Pain in Opioid Use Disorder

Overseen By R. Ross MacLean, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: VA Office of Research and Development

Must be taking: Buprenorphine, Methadone

Disqualifiers: Bipolar, Psychotic, Suicidal ideation, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist Veterans dealing with severe chronic pain and opioid use disorder (OUD) through a program called Steps 2 Change (S2C). The study will evaluate whether a walking program, combined with pain education, can alleviate chronic pain while Veterans receive medication-assisted treatment for OUD. Participants will use a pedometer to track their steps and gradually increase their walking activity each week. Veterans who are on a stable dose of medication for OUD, experience frequent pain that affects daily life, and can walk a block are suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering Veterans a chance to be among the first to benefit from this innovative approach.

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 prior data suggests that this adaptive walking intervention is safe for Veterans with chronic pain and opioid use disorder?

Research shows that the Steps 2 Change (S2C) program uses walking with a step counter and flexible goals to help manage chronic pain. This method gently increases physical activity to prevent overexertion. Early studies indicate that such walking programs are generally well-tolerated. Participants in similar programs have reported few side effects, mostly minor discomfort typical of starting a new exercise routine. This suggests that the S2C treatment is likely safe for most people. As a Phase 1 trial, the main goal is to assess the treatment's safety and tolerability. Treatments at this stage undergo close monitoring to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Steps 2 Change (S2C) treatment because it takes a fresh approach to managing chronic pain in individuals with opioid use disorder. Unlike traditional treatments that might focus on medications or purely psychological interventions, S2C combines physical activity with pain education. It encourages participants to gradually increase their daily steps, which can help manage pain without additional medication. By emphasizing low-impact activity and teaching strategies to prevent pain flare-ups, S2C offers a holistic, non-pharmacological method that could be more sustainable and empowering for patients.

What evidence suggests that this trial's treatments could be effective for chronic pain in opioid use disorder?

Research shows that walking programs can help manage chronic pain in people with opioid use disorder (OUD). In this trial, participants may join the Steps 2 Change (S2C) program, which combines walking with goal-setting to gradually increase movement. Studies have found that increased activity can lower pain levels and improve overall well-being. The S2C program uses pedometers to track steps and encourages participants to increase their step count each week. By focusing on gentle activities, S2C aims to manage pain without medications. This approach shows promise for Veterans dealing with both chronic pain and OUD. ^{1 3 6 7 8}

Who Is on the Research Team?

R. Ross MacLean, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Steps 2 Change (S2C) Experimental Treatment 1 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: Control Active Control 1 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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A cohort of patients with chronic pain and substance use disorder showed significant improvements in depression, pain, and quality of life after participating in a comprehensive inpatient treatment program that included detoxification, qigong, and 12-step recovery support.

The most notable improvements were observed between the initial assessment and the second assessment at 30 days, indicating that this integrated approach may effectively address both chronic pain and substance use issues in patients who have not responded to traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive treatment for patients with chronic pain in a 12-step based substance use disorder program. Przekop, P., Przekop, A., Haviland, MG., et al.[2019]

A 10-week walking program integrated into cognitive behavioral therapy for chronic pain significantly increased participants' daily step counts by an average of 1648 steps, indicating its effectiveness in promoting physical activity.

The program was safe, with mostly minor and temporary adverse events reported, and it was equally effective whether delivered in person or via interactive voice response, suggesting flexibility in treatment delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating walking into cognitive behavioral therapy for chronic pain: safety and effectiveness of a personalized walking intervention. Heapy, AA., Tankha, H., Higgins, DM., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health outcomes among detoxification patients: The role of chronic pain. Woodhead, EL., Brief, D., Below, M., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging Accelerometry as a Prognostic Indicator for Increase in Opioid Withdrawal Symptoms. Lambert, TP., Gazi, AH., Harrison, AB., et al.[2023]

The Physical Activity Decline (PAD) score demonstrated strong internal consistency (Cronbach's alpha = 0.92) and reliability (ICC = 0.93) in assessing physical activity decline in 62 patients with chronic pain, indicating it is a dependable tool for measuring changes in activity levels.

The PAD score showed adequate construct validity, correlating moderately with disability and changes in physical activity levels, although a significant portion of patients (38.7%) scored the lowest possible score, suggesting a potential floor effect that may limit its sensitivity in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability and validity of the PAD questionnaire: a measure to assess pain-related decline in physical activity. Verbunt, JA.[2015]

Participants with chronic pain found that receiving reminders significantly improved their adherence to wearing the ActiGraph, which is crucial for accurate activity assessment.

Mind-body skills learned from the activity programs, such as mindfulness and pacing, helped participants increase their activity levels, while ongoing medical issues were identified as barriers to activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative investigation of activity measurement and change following a mind-body activity program for chronic pain. Popok, PJ., Greenberg, J., Gates, MV., et al.[2022]

In a study of 229 Veterans with chronic back pain, those using opioids who participated in a walking intervention increased their step count by over 1,200 steps, while those receiving usual care decreased their step count by nearly 400 steps, highlighting the intervention's effectiveness.

The results suggest that walking can be a beneficial alternative pain management strategy for patients on opioids, as it encourages increased physical activity to help manage back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid use and walking among patients with chronic low back pain. Krein, SL., Bohnert, A., Kim, HM., et al.[2016]

A study involving 121 participants with chronic pain found that a 3-month group-based self-management course did not significantly improve patient activation compared to a low-impact outdoor physical activity group.

Both interventions were equally effective, suggesting that simple physical activity may be as beneficial as structured self-management courses for individuals with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effect of a chronic pain self-management intervention delivered by an easily accessible primary healthcare service: a randomised controlled trial. Nøst, TH., Steinsbekk, A., Bratås, O., et al.[2020]

The iPOPP pilot trial aims to assess the feasibility and acceptability of a walking intervention for older adults with chronic musculoskeletal pain, involving 150 participants aged 65 and older over a 12-week follow-up period.

This study will utilize a mixed-methods approach to evaluate the intervention's fidelity and gather insights on barriers and facilitators to behavior change, which will inform the design of a larger randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility and acceptability of a physical activity intervention for older people with chronic musculoskeletal pain: The iPOPP pilot trial protocol. Healey, EL., Jinks, C., Foster, NE., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and exercise interventions for individuals with opioid use disorder: a scoping review. Shreffler, J., Genova, G., Huecker, M.[2022]

The MySafeRx mobile platform, which integrates motivational coaching and adherence monitoring for buprenorphine/naloxone treatment, was found to be usable and acceptable among participants, with a high mean usability score of 78.4 and positive feedback on its features.

Despite the positive reception, the study faced challenges in recruitment and did not show significant differences in outcomes between the MySafeRx group and the standard care control group, indicating that while the platform is promising, its impact on adherence and treatment success may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the feasibility, usability and acceptability of the MySafeRx platform among individuals in outpatient buprenorphine treatment: Lessons learned from a pilot randomized controlled trial. Janzow, GE., Harding, C., Flores, M., et al.[2023]

Citations

1. reporter.nih.gov reporter.nih.gov/search/15EEC10D4C8DC5D37598B8961CAA4A01A2FFCEB861BF/project-details/10975946

An adaptive walking intervention to manage chronic pain ... An adaptive walking intervention to manage chronic pain in veterans with opioid use disorder engaged in opioid agonist treatment. Project Number5IK2CX002286 ...

2. withpower.com withpower.com/trial/phase-1-chronic-pain-9-2021-386d9

Adaptive Walking Intervention for Chronic Pain in Opioid Use ... Steps 2 Change is unique because it combines a pedometer-assisted walking program with adaptive goals to increase physical activity, specifically targeting ...

3. ctv.veeva.com ctv.veeva.com/study/an-adaptive-walking-intervention-to-manage-chronic-pain-in-veterans-with-opioid-use-disorder-engaged

An Adaptive Walking Intervention to Manage Chronic Pain in ... Steps to Change (S2C) is a pain-focused treatment comprised of weekly 60-minute treatment sessions held over four consecutive weeks within the a ...

4. sciencedirect.com sciencedirect.com/org/science/article/pii/S1929074824001227

Protocol Efficacy of Integrating the Management of Pain ... Chronic pain is common among individuals with opioid use disorder (OUD) who are maintained on medications for OUD (MOUD; eg, buprenorphine or methadone).

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835320

Feasibility of a Mind-Body Program for Chronic Pain This randomized clinical trial evaluates the feasibility of a mind-body walking program and a health education program among a ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/44/NCT05051644/ICF_000.pdf

An adaptive walking intervention to manage chronic pain in ... The knowledge from this study will provide information on whether a brief treatment combined with opioid agonist treatment can increase self- ...

7. medicine.yale.edu medicine.yale.edu/internal-medicine/genmed/addictionmedicine/profile/sara-edmond/academic-publications/?profilePageName=sara-edmond&concept=Self-Management

Publication Search < Sara N Edmond, PhD < Yale Program in ... Commentary on the Veterans Health Administration Pain Management, Opioid Safety, and Prescription Drug Monitoring Program (PMOP) pain measure set.

8. centerwatch.com centerwatch.com/clinical-trials/listings/condition/45/chronic-pain?activelyRecruiting=false&page=747

Chronic Pain Clinical Research Trials Steps to Change (S2C) is a pain-focused treatment comprised of weekly 60-minute treatment sessions held over four consecutive weeks within the a Veterans Health ...