Community-Engaged Options to Facilitate Opioid Reduction

Chronic Pain Clinical Trial

— COMFORT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05098158
• Other study ID #: 18111
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2020
• Est. completion date: December 15, 2021

Study information

• Verified date: October 2021
• Source: Washington State University
• Contact: Marian Wilson, PhD
• Phone: 5093247443
• Email: marian.wilson[@]wsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 15, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• Non-pharmacological pain treatment
Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.

Locations

Country	Name	City	State
United States	Community Health Association of Spokane	Spokane	Washington
United States	Washington State University College of Nursing	Spokane	Washington

Sponsors (4)

Lead Sponsor	Collaborator
Washington State University	Rayce Rudeen Foundation, Spokane Regional Health District, University of Washington Institute for Translational Health Science (KL2)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Attendance in scheduled telehealth sessions	Percentage of attendance for each participant in their scheduled telehealth sessions (e.g. 3/6 sessions = 50%)	6 weeks
Other	Satisfaction with intervention	3-item program satisfaction survey to gauge participant satisfaction with the interventions using 1-7 Likert scale (score range 3 to 21 where higher score indicates higher satisfaction)	6 weeks
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Anxiety using Generalized Anxiety Disorder (GAD-7)	7-item scale with score range 0-21 (higher score is worsened anxiety)	6 weeks
Secondary	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
Secondary	Current Opioid Misuse Measure	17-item scale to ask about use of opioids (range 0-64 with higher scores indicating more misuse)	6 weeks
Secondary	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