Clinical trial NCT05098158: Community-Engaged Options to Facilitate Opioid Reduction
Official title: Community-Engaged Options to Maximize and Facilitate Opioid Reduction Through Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain
opioid
complementary
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: Spokane Regional Health District
name: University of Washington Institute for Translational Health Science (KL2)
name: Rayce Rudeen Foundation
First posted: 2021-10-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group studied over 6 weeks time
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain intensity rating
timeFrame: 6 weeks
measure: PROMIS Pain interference rating
timeFrame: 6 weeks
Secondary outcomes:
measure: Depressive symptoms using Patient Health Questionnaire (PHQ-8)
timeFrame: 6 weeks
measure: PROMIS Self-efficacy for managing symptoms short form 4a
timeFrame: 6 weeks
measure: PROMIS Self-efficacy for managing emotions short form 4a
timeFrame: 6 weeks
measure: Anxiety using Generalized Anxiety Disorder (GAD-7)
timeFrame: 6 weeks
measure: Interpersonal Needs Questionnaire
timeFrame: 6 weeks
measure: Current Opioid Misuse Measure
timeFrame: 6 weeks
measure: Spiritual Well-being Index
timeFrame: 6 weeks
Other outcomes:
measure: Attendance in scheduled telehealth sessions
timeFrame: 6 weeks
measure: Satisfaction with intervention
timeFrame: 6 weeks
Locations:
city: Spokane
country: United States
facility: Community Health Association of Spokane
state: Washington
city: Spokane
country: United States
facility: Washington State University College of Nursing
state: Washington
Study officials:
References: