Community-Engaged Options to Facilitate Opioid Reduction

Study Overview
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Brief Summary
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This study investigates how adults prescribed opioids for chronic noncancer pain respond to invitations to try non-opioid options of massage therapy, yoga therapy, chiropractic and physical therapies. Due to the COVID-19 pandemic, these options will be available via telehealth consultation visits using a computer or smartphone with internet connection. The investigators will measure effects on pain, pain-related symptoms, and opioid use over time using a single-group design.

Detailed Description
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Participants will be recruited from local primary care practices and asked to complete a baseline survey. They will then meet with a registered nurse via teleconference for a complete pain assessment. At the end of the session, participants will be asked to choose two of four available modalities for telehealth consultation. Participants will be scheduled for six telehealth sessions, once per week x six weeks with three consultations per each chosen therapy. Measurements of pain, mood, sleep, medicine use will be captured at baseline, three weeks and six weeks and examined for changes over time.

Official Title
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Community-Engaged Options to Maximize and Facilitate Opioid Reduction Through Treatment

Conditions
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Chronic Pain

Intervention / Treatment
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* Other: Non-pharmacological pain treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: enrollment in treatment at the CHAS Perry St or partnering clinic; age greater than 18 years; ability to read, speak, and write English; diagnosed with a chronic, non-cancer-based painful medical condition; ability to provide informed consent. Exclusion Criteria: pregnancy; diagnosis of a cancer-based painful medical condition; any other medical or psychiatric condition that the PI or Co-PI physician of record determine might compromise safe study participation (including but not limited to active psychosis, history of frequent psychiatric hospitalizations, severe anxiety with claustrophobia, aggression)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Single group studied over 6 weeks time
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm pain treatment<br>Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks | Other: Non-pharmacological pain treatment<br>* Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pain intensity rating | 3 items asking about pain severity (range 3 to 15 with higher score worse pain intensity) | 6 weeks | 
| PROMIS Pain interference rating | 8 items asking about pain interference with life (range 8 to 40 with higher score worse pain interference) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms using Patient Health Questionnaire (PHQ-8) | Patient Health Questionnaire (PHQ-8) 8-item scale with score range 0-24 (higher score is worsened depressive symptoms) | 6 weeks | 
| PROMIS Self-efficacy for managing symptoms short form 4a | Self-efficacy self-report (range 4-20 with higher score better symptom management self-efficacy) | 6 weeks | 
| PROMIS Self-efficacy for managing emotions short form 4a | Self-efficacy self-report (range 4-20 with higher score better emotion management self-efficacy) | 6 weeks | 
| Anxiety using Generalized Anxiety Disorder (GAD-7) | 7-item scale with score range 0-21 (higher score is worsened anxiety) | 6 weeks | 
| Interpersonal Needs Questionnaire | 9-item scale asking how one feels about others score range 0-18 (lower score indicates more unmet interpersonal needs) | 6 weeks | 
| Current Opioid Misuse Measure | 17-item scale to ask about use of opioids (range 0-64 with higher scores indicating more misuse) | 6 weeks | 
| Spiritual Well-being Index | 4-items to ask about spiritual well-being (range 4-20 with higher scores indicating more spiritual well-being) | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain, opioid, complementary