Community-Engaged Options to Facilitate Opioid Reduction

NCT05098158 | Completed Results

• 1 other identifier: 18111
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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. 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.

Conditions

Chronic Pain

Keywords

chronic pain; opioid; complementary

Outcome Measures

Primary Outcomes (2)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Rating

  Full scale name is PROMIS (Patient-Reported Outcome Measurement Information System) Pain Intensity Scale version 3a that measures the construct pain intensity or severity in three items for how much it hurts on average, at its worst and at its least in the past 7 days. Scale ranges from minimum "no pain" =1 to maximum "very severe" =5 pain with a possible sum of 3-15. A total sum of the 3 items is converted into a T-score where 50 is equivalent to the U.S. general population average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a worse outcome (range 40-70 after T-score conversion).

  6 weeks

• PROMIS Pain Interference Rating

  Scale name is PROMIS (Patient-Reported Outcome Measurement Information System) Pain Interference Scale that measures the construct pain interference in 8 items for how much pain interferes with a variety of activities in the past 7 days. Scale ranges from minimum "not at all" =1 to maximum "very much" =5 pain with a possible sum of 8-40. A total sum of the 8 items is converted into a T-score where 50 is equivalent to the U.S. general population average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a worse outcome.

  6 weeks

Secondary Outcomes (7)

• Depressive Symptoms Using Patient Health Questionnaire (PHQ-8)

  6 weeks

• PROMIS Self-efficacy for Managing Symptoms Short Form 4a

  6 weeks

• PROMIS Self-efficacy for Managing Emotions Short Form 4a

  6 weeks

• Anxiety Using Generalized Anxiety Disorder (GAD-7)

  6 weeks

• Interpersonal Needs Questionnaire

  6 weeks

Other Outcomes (2)

• Percentage of Attendance in Scheduled Telehealth Sessions

  6 weeks

• IBM Computer Usability and Satisfaction Questionnaires

  6 weeks

Study Arms (1)

Single arm pain treatment

EXPERIMENTAL

Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks

Other: Non-pharmacological pain treatment

Interventions

Non-pharmacological pain treatment OTHER

Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.

Single arm pain treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington State University: lead
• Spokane Regional Health District: collaborator
• University of Washington Institute for Translational Health Science (KL2): collaborator
• Rayce Rudeen Foundation: collaborator

Study Sites (2)

Community Health Association of Spokane

Spokane, Washington, 99201, United States

Location

Washington State University College of Nursing

Spokane, Washington, 99201, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Marian Wilson
• Organization: Washington State University

marian.wilson@wsu.edu

509-324-7443

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single group studied over 6 weeks time

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: October 28, 2021
• Study Start: July 10, 2020
• Primary Completion: January 3, 2022
• Study Completion: January 3, 2022
• Last Updated: October 6, 2025
• Results First Posted: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)