Chronic PainCOMFORTNCT05098158
Community-Engaged Options to Facilitate Opioid Reduction
A study testing Non-pharmacological pain treatment in people with Chronic Pain, run by Washington State University at 2 sites in United States.
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. Options will be available via telehealth consultation visits using a computer or smartphone with internet connection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Non-pharmacological pain treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jul 2020to 3 Jan 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Community Health Association of Spokane
Spokane, Washington, 99201
Washington State University College of Nursing
Spokane, Washington, 99201
About this study
Official title: Community-Engaged Options to Maximize and Facilitate Opioid Reduction Through Treatment
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Non-pharmacological pain treatment
- Keywords
- chronic pain, opioid, complementary
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-pharmacological pain treatmentOther
Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.
| Study group | Role | What they receive |
|---|---|---|
| Single arm pain treatment | Experimental | Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks Receives: Other: Non-pharmacological pain treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 6 weeks
Secondary outcomes (7)
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)
Measured: 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).
Measured: 6 weeks
PROMIS Self-efficacy for Managing Emotions Short Form 4a
Self-efficacy self-report (range 4-20 ). Converted to T score where 50 equals the US adults average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a better outcome for self-efficacy for managing emotions (range 40-70 after T-score conversion).
Measured: 6 weeks
Anxiety Using Generalized Anxiety Disorder (GAD-7)
7-item scale with score range 0-21 (higher score is worsened anxiety)
Measured: 6 weeks
Interpersonal Needs Questionnaire
9-item scale asking how one feels about others score range 0-28 (lower score indicates more unmet interpersonal needs)
Measured: 6 weeks
Current Opioid Misuse Measure
17-item scale to ask about use of opioids (range 0-64 with higher scores indicating more misuse)
Measured: 6 weeks
Spiritual Well-being Index
4-items to ask about spiritual well-being (range 4-20 with higher scores indicating more spiritual well-being)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start10 Jul 2020
- Primary completion3 Jan 2022
- Study completion3 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group studied over 6 weeks time
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- Spokane Regional Health District, University of Washington Institute for Translational Health Science (KL2), Rayce Rudeen Foundation
- Responsible party
- Principal investigator, Marian Wilson, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098158
- Sponsor's protocol ID
- 18111
- Acronym
- COMFORT
- Status last verified
- Sep 2025
- First submitted
- 13 Jul 2020
- Last updated
- 6 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No