Adaptive Walking Intervention for Chronic Pain in Opioid Use Disorder
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: VA Office of Research and Development
Must be taking: Buprenorphine, Methadone
Disqualifiers: Bipolar, Psychotic, Suicidal ideation, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is 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.
678910How 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.
6891011Eligibility 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
+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.
+2 more
Trial 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
Participant Groups
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VA Connecticut Healthcare System West Haven Campus, West Haven, CTWest Haven, CT
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Health outcomes among detoxification patients: The role of chronic pain. [2021]Understanding associations between chronic pain and health outcomes among detoxification patients may help improve treatment outcomes and abstinence rates. Exercise is a modifiable lifestyle factor that may reduce the effect of pain on outcomes in this population. The current study examined whether baseline pain, exercise, and their interaction were associated with psychiatric and medical severity, and abstinence self-efficacy, over six months following detoxification. Participants were veteran patients in alcohol or opioid detoxification treatment (N = 298) who were followed for six months (91.1%). Psychiatric severity and abstinence self-efficacy improved over the six months after detoxification; medical severity was stable. More intense pain at baseline was associated with poorer psychiatric and medical outcomes during the post-detoxification period. Regular exercise at baseline was associated with less psychiatric severity and more abstinence self-efficacy during the post-detoxification period. A significant pain by exercise interaction at baseline indicated that regular exercise was associated with more abstinence self-efficacy during the post-detoxification period only among participants with less intense pain. Pain by exercise interactions was not significant for the outcomes of psychiatric and medical severity. Among detoxification patients, exercise may be beneficial in improving outcomes among those with less intense pain.
Physical activity and exercise interventions for individuals with opioid use disorder: a scoping review. [2022]Exercise may be a valuable adjunct therapy for individuals with opioid use disorder (OUD) due to its known benefits in brain health, sleep, overall quality of life, and reduced anxiety and depression. Additionally, physical activity may mitigate the experience of pain, leading to better control of chronic pain. The purpose of this scoping review was to evaluate the evidence to support physical activity (which includes exercise) interventions for individuals with OUD. Systematic searches were conducted by a librarian in September 2021 in PubMed, PsycINFO, EMBASE, Web of Science, Cochrane CENTRAL, and clinicaltrials.gov. Two reviewers independently screened titles and abstracts to reduce risk of bias. A total of 13 studies met inclusion criteria. Ten publications presented data specifically studying a physical activity intervention for OUD. Three studies provided retrospective data on the exercise experience and attitudes. Results indicated different exercise modalities led to positive outcomes related to immune function, reduction of pain, cravings, anxiety and depression, as well as improvements in mood and quality of life. Additionally, participants noted exercise as an acceptable and feasible adjunct treatment. Exercise may be a valuable adjunct therapy for individuals with OUD; however, the majority of the published literature consisted of small samples presenting an opportunity for future investigators to corroborate findings with larger sample sizes, utilizing different exercise modalities in different populations of patients with OUD.
Leveraging Accelerometry as a Prognostic Indicator for Increase in Opioid Withdrawal Symptoms. [2023]Treating opioid use disorder (OUD) is a significant healthcare challenge in the United States. Remaining abstinent from opioids is challenging for individuals with OUD due to withdrawal symptoms that include restlessness. However, to our knowledge, studies of acute withdrawal have not quantified restlessness using involuntary movements. We hypothesized that wearable accelerometry placed mid-sternum could be used to detect withdrawal-related restlessness in patients with OUD. To study this, 23 patients with OUD undergoing active withdrawal participated in a protocol involving wearable accelerometry, opioid cues to elicit craving, and non-invasive Vagal Nerve Stimulation (nVNS) to dampen withdrawal symptoms. Using accelerometry signals, we analyzed how movements correlated with changes in acute withdrawal severity, measured by the Clinical Opioid Withdrawal Scale (COWS). Our results revealed that patients demonstrating sinusoidal-i.e., predominantly single-frequency oscillation patterns in their motion almost exclusively demonstrated an increase in the COWS, and a strong relationship between the maximum power spectral density and increased withdrawal over time, measured by the COWS (R = 0.92, p = 0.029). Accelerometry may be used in an ambulatory setting to indicate the increased intensity of a patient's withdrawal symptoms, providing an objective, readily-measurable marker that may be captured ubiquitously.
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]Label="Background" NlmCategory="UNASSIGNED">Increasing buprenorphine/naloxone (B/N) access for opioid use disorder (OUD) is essential yet ensuring adherence and preventing diversion remains challenging. This study examines the feasibility, usability, and acceptability of MySafeRx, a mobile platform integrating motivational coaching, adherence monitoring, and electronic dispensing during office-based B/N treatment.
Comprehensive treatment for patients with chronic pain in a 12-step based substance use disorder program. [2019]Patients with chronic pain (CP) and substance use disorder (SUD) are complex, not yet adequately described, and in need of comprehensive treatments that address both diseases concurrently. Our objectives were to (a) describe a cohort of CP patients who failed traditional treatment (mainly opioids) - then developed opioid use disorder (OUD) and other SUDs and (b) evaluate a comprehensive inpatient treatment program for these patients. Patients were enrolled in an inpatient CP program. Treatment consisted of medical detoxification, group process/education, external and internal qigong, osteopathic manual medicine, and qigong-based mindfulness. Patients also received 20 h per week of 12-step recovery-based SUD treatment. Patients were evaluated at the beginning of treatment (first assessment, day 1-5 range) and at days 30 and 45. Assessments were: Beck Depression Inventory-II, Brief Pain Inventory, West Haven-Yale Multidimensional Pain Inventory (patient section), and McGill Pain Questionnaire. The Global Impression of Change Scale was administered at day 45. A mixed model analysis was used to evaluate treatment progress. Demographic data revealed an older cohort with OUD, other SUDs, and multiple pain diagnoses who failed traditional treatment. Questionnaire evaluations were consistent and similar across all of the above measures: patients' scores showed marked, statistically significant improvements in depression, pain, and quality of life ratings. The most substantial improvements occurred between the first and second assessments. The findings are sufficiently encouraging to warrant further evaluation of the protocol and to plan comparative studies.
Opioid use and walking among patients with chronic low back pain. [2016]This study examined the effect of a walking intervention on step counts among patients with chronic back pain who report opioid use. Data were collected as part of a randomized trial to reduce back-pain-related disability. Participants (n = 118 usual care, 111 intervention) were Veterans receiving care within one healthcare system. Step counts were collected at baseline, 6 mo, and 12 mo via an uploading pedometer. Self-reported opioid use was collected by survey. More than 40% (n = 99) of participants reported opioid use at baseline. After adjustment, the predicted mean step count for baseline opioid users assigned to the intervention increased by more than 1,200 steps compared with a reduction of nearly 400 steps for those assigned to usual care (between-group difference = 1,625 steps, p = 0.004). Among nonopioid users, there was no change for those in the intervention (-16 steps) and an increase of about 660 steps for those assigned to usual care (between-group difference = 683 steps, p = 0.17). These data show that patients taking opioids may engage in walking to help manage their back pain. This finding emphasizes the importance of encouraging the use of alternative pain management strategies for these patients.
The feasibility and acceptability of a physical activity intervention for older people with chronic musculoskeletal pain: The iPOPP pilot trial protocol. [2021]This pilot trial will inform the design and methods of a future full-scale randomized controlled trial (RCT) and examine the feasibility, acceptability and fidelity of the Increasing Physical activity in Older People with chronic Pain (iPOPP) intervention, a healthcare assistant (HCA)-supported intervention to promote walking in older adults with chronic musculoskeletal pain in a primary care setting.
Short-term effect of a chronic pain self-management intervention delivered by an easily accessible primary healthcare service: a randomised controlled trial. [2020]To investigate the effects on persons with chronic pain after 3 months of a group-based chronic pain self-management course compared with a drop-in, low-impact outdoor physical group activity on patient activation and a range of secondary outcomes.
Reliability and validity of the PAD questionnaire: a measure to assess pain-related decline in physical activity. [2015]To examine the reliability and validity of the physical activity decline (PAD) score: a measure for assessing a decline in the level of physical activity in patients with chronic pain.
Incorporating walking into cognitive behavioral therapy for chronic pain: safety and effectiveness of a personalized walking intervention. [2023]We examined the effectiveness and safety of a walking program offered as part of cognitive behavioral therapy for chronic pain (CBT-CP). Participants were randomized to 10 weeks of CBT-CP, delivered either in person or by interactive voice response. Participants reported pedometer-measured step counts daily throughout treatment and received a weekly goal to increase their steps by 10% over the prior week's average. Walking-related adverse events (AEs) were assessed weekly. Participants (n = 125) were primarily male (72%), and white (80%) with longstanding pain (median: 11 years). There was no significant difference between treatment groups in rate of change in daily steps, but there was a significant increase in steps from baseline to treatment termination in the combined study sample (1648 steps (95% CI 1063-2225)). Participants classified as active doubled. AEs were mostly minor and temporary. Treatment was effective and safe whether the program was delivered in-person or remotely.Trial registration number: clinicaltrials.gov identifier: NCT01025752.
A qualitative investigation of activity measurement and change following a mind-body activity program for chronic pain. [2022]Increasing activity is important yet challenging among people with chronic pain. Objective assessment of activity using accelerometers (i.e., ActiGraph) has gained popularity, but reactivity to assessment and non-adherence to wearing the ActiGraph may bias data. We explored: 1) experiences of wearing the ActiGraph to identify ways to increase adherence and facilitate accurate assessment of activity; and 2) barriers and facilitators to increasing activity following two mind-body activity programs to optimize future interventions. We conducted semi-structured exit interviews with 13 participants with heterogenous chronic pain who completed a randomized controlled trial of two mind-body activity programs. We analyzed transcripts using a framework approach to generate themes. Participants indicated that receiving reminders increased ActiGraph wear adherence and reported that program skills such as gratitude, pacing, mindfulness, and deep breathing were facilitators to increasing activity, while medical problems were barriers. Interventions aiming to increase activity may benefit from emphasizing mind-body skills and sending ActiGraph wear reminders.