Community-Engaged Options to Facilitate Opioid Reduction

Washington State University21 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Chronic Pain

Interventions

Non-pharmacological pain treatmentOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (2)

Community Health Association of Spokane

Spokane, Washington, United States

Washington State University College of Nursing

Spokane, Washington, United States

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: 6 weeks

Secondary Outcomes

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)

Time frame: 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). Scores converted into T scores with 50 as the average for US adults and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a better outcome (range 40-70 after T-score conversion).

Data from ClinicalTrials.gov

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