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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Engaged Options to Maximize and Facilitate Opioid Reduction Through Treatment
- ClinicalTrials.gov ID
- NCT05098158
- Acronym / sponsor ID
- COMFORT / 18111
- Conditions
- Chronic Pain
- Keywords
- chronic pain, opioid, complementary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- Spokane Regional Health District, University of Washington Institute for Translational Health Science (KL2), Rayce Rudeen Foundation
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 3 Jan 2022 (actual)
- First posted
- 28 Oct 2021 (actual)
- Results
- Posted 6 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group studied over 6 weeks time
| Arm | Type | Receives |
|---|---|---|
| Single arm pain treatment | Experimental | Other: Non-pharmacological pain treatmentArm includes usual pain care plus the chosen two telehealth interventions x 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-pharmacological pain treatmentParticipant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies. | Other | Single arm pain treatment |
Primary outcome
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Rating
Time frame: 6 weeks
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).
PROMIS Pain Interference Rating
Time frame: 6 weeks
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.
7 secondary outcomes
Depressive Symptoms Using Patient Health Questionnaire (PHQ-8)
Time frame: 6 weeks
PROMIS Self-efficacy for Managing Symptoms Short Form 4a
Time frame: 6 weeks
PROMIS Self-efficacy for Managing Emotions Short Form 4a
Time frame: 6 weeks
Anxiety Using Generalized Anxiety Disorder (GAD-7)
Time frame: 6 weeks
Interpersonal Needs Questionnaire
Time frame: 6 weeks
Current Opioid Misuse Measure
Time frame: 6 weeks
Spiritual Well-being Index
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-pharmacological pain treatment in people with Chronic Pain, run by Washington State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Rating (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.