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Community-Engaged Options to Facilitate Opioid Reduction

Not Applicable
Conditions
Chronic Pain
Interventions
Other: Non-pharmacological pain treatment
Registration Number
NCT05098158
Lead Sponsor
Washington State University
Brief Summary

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

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
30
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.
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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)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Single arm pain treatmentNon-pharmacological pain treatmentArm includes usual pain care plus the chosen two telehealth interventions x 6 weeks
Primary Outcome Measures
NameTimeMethod
PROMIS Pain interference rating6 weeks

8 items asking about pain interference with life (range 8 to 40 with higher score worse pain interference)

Patient-Reported Outcomes Measurement Information System (PROMIS) Pain intensity rating6 weeks

3 items asking about pain severity (range 3 to 15 with higher score worse pain intensity)

Secondary Outcome Measures
NameTimeMethod
PROMIS Self-efficacy for managing symptoms short form 4a6 weeks

Self-efficacy self-report (range 4-20 with higher score better symptom management self-efficacy)

Anxiety using Generalized Anxiety Disorder (GAD-7)6 weeks

7-item scale with score range 0-21 (higher score is worsened anxiety)

Interpersonal Needs Questionnaire6 weeks

9-item scale asking how one feels about others score range 0-18 (lower score indicates more unmet interpersonal needs)

Depressive symptoms using Patient Health Questionnaire (PHQ-8)6 weeks

Patient Health Questionnaire (PHQ-8) 8-item scale with score range 0-24 (higher score is worsened depressive symptoms)

Current Opioid Misuse Measure6 weeks

17-item scale to ask about use of opioids (range 0-64 with higher scores indicating more misuse)

Spiritual Well-being Index6 weeks

4-items to ask about spiritual well-being (range 4-20 with higher scores indicating more spiritual well-being)

PROMIS Self-efficacy for managing emotions short form 4a6 weeks

Self-efficacy self-report (range 4-20 with higher score better emotion management self-efficacy)

Trial Locations

Locations (2)

Community Health Association of Spokane

🇺🇸

Spokane, Washington, United States

Washington State University College of Nursing

🇺🇸

Spokane, Washington, United States

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