An interventional study of Non-pharmacological pain treatment in Chronic Pain, sponsored by Washington State University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by Washington State University · Not applicable, Interventional, and Supportive care
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.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 21 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Washington State University is the lead sponsor of 82 studies on the registry; 16 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks
Other: Non-pharmacological pain treatment
Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.
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
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).
Time frame: 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).
Time frame: 6 weeks
Anxiety Using Generalized Anxiety Disorder (GAD-7)
7-item scale with score range 0-21 (higher score is worsened anxiety)
Time frame: 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)
Time frame: 6 weeks
Current Opioid Misuse Measure
17-item scale to ask about use of opioids (range 0-64 with higher scores indicating more misuse)
Time frame: 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)
Time frame: 6 weeks
Percentage of Attendance in Scheduled Telehealth Sessions
Percentage of scheduled telehealth sessions attended by participants (calculated as total number attended/total number scheduled)
Time frame: 6 weeks
IBM Computer Usability and Satisfaction Questionnaires
The IBM Computer Usability and Satisfaction Questionnaires was adapted to measure tele-visit program usability and satisfaction with a 4-item survey to gauge participant satisfaction with the intervention using 1-7 Likert scale. A total mean satisfaction rating was generated from the combined mean 4 satisfaction items (possible mean range 1-7 where higher score means higher satisfaction) on a Likert-style scale: The Likert-style scale for each item was: 1: Strongly disagree- 7: Strongly agree where higher numbers indicate greater satisfaction.
Time frame: 6 weeks
| Milestone | Single Arm Pain Treatment |
|---|---|
| Started | 16 |
| Yoga intervention | 11 |
| Physical therapy intervention | 9 |
| Massage intevention | 8 |
| Chiropractic intervention | 4 |
| Completed | 15 |
| Not completed | 1 |
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).
| score on a scale | Single Arm Pain Treatment |
|---|---|
| Pre | 68.3 ± 6.3 |
| Post | 64.4 ± 6.0 |
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.
| units on a scale | Single Arm Pain Treatment |
|---|---|
| Pre | 69.9 ± 5.5 |
| Post | 64.3 ± 8.3 |
Patient Health Questionnaire (PHQ-8) 8-item scale with score range 0-24 (higher score is worsened depressive symptoms)
| score on a scale | Single Arm Pain Treatment |
|---|---|
| Pre | 10.7 ± 5.9 |
| Post | 7.6 ± 5.0 |
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).
| units on a scale | Single Arm Pain Treatment |
|---|---|
| Pre | 39.4 ± 5.2 |
| Post | 41.2 ± 5.3 |
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).
| units on a scale | Single Arm Pain Treatment |
|---|---|
| Pre | 43.4 ± 6.3 |
| Post | 44.4 ± 5.1 |
7-item scale with score range 0-21 (higher score is worsened anxiety)
| units on a scale | Single Arm |
|---|---|
| Pre | 5.9 ± 4.7 |
| Post | 5.2 ± 5.2 |
9-item scale asking how one feels about others score range 0-28 (lower score indicates more unmet interpersonal needs)
| units on a scale | Single Arm |
|---|---|
| Pre | 27.7 ± 14.4 |
| Post | 24.5 ± 13.5 |
17-item scale to ask about use of opioids (range 0-64 with higher scores indicating more misuse)
| units on a scale | Single Arm |
|---|---|
| Pre | 7.1 ± 4.9 |
| Post | 6.8 ± 4.4 |
4-items to ask about spiritual well-being (range 4-20 with higher scores indicating more spiritual well-being)
| units on a scale | Single Arm |
|---|---|
| Pre | 15 ± 4.1 |
| Post | 15.1 ± 3.5 |
Percentage of scheduled telehealth sessions attended by participants (calculated as total number attended/total number scheduled)
| percentage of sessions attended | Single Arm |
|---|---|
| Percentage of Attendance in Scheduled Telehealth Sessions | 95.8 |
The IBM Computer Usability and Satisfaction Questionnaires was adapted to measure tele-visit program usability and satisfaction with a 4-item survey to gauge participant satisfaction with the intervention using 1-7 Likert scale. A total mean satisfaction rating was generated from the combined mean 4 satisfaction items (possible mean range 1-7 where higher score means higher satisfaction) on a Likert-style scale: The Likert-style scale for each item was: 1: Strongly disagree- 7: Strongly agree where higher numbers indicate greater satisfaction.
| mean of summed scores on a scale | Single Arm |
|---|---|
| IBM Computer Usability and Satisfaction Questionnaires | 6.59 ± 0.62 |
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm Pain Treatment | 0/16 (0%) | 0/16 (0%) | 1/16 (6.3%) |
| Event | Single Arm Pain Treatment |
|---|---|
| MildEar and labyrinth disorders | 1/16 |
| Age, Categorical(Participants) | Single Arm Pain Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 4 |
| Age, Continuous(years) | Single Arm Pain Treatment |
|---|---|
| Mean | 60.4 ± 10.4 |
| Sex: Female, Male(Participants) | Single Arm Pain Treatment |
|---|---|
| Female | 12 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Single Arm Pain Treatment |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 15 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Single Arm Pain Treatment |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 15 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Single Arm Pain Treatment |
|---|---|
| United States | 16 |
| PROMIS Pain Intensity Scale(units on a scale) | Single Arm Pain Treatment |
|---|---|
| Mean | 68.6 ± 6.5 |
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Washington State University