Trial Outcomes & Findings for Community-Engaged Options to Facilitate Opioid Reduction (NCT NCT05098158)

NCT ID: NCT05098158

Last Updated: 2025-10-06

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2025-10-06

Participant Flow

Participant milestones

Measure	Single Arm Pain Treatment Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks Non-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.
Overall Study STARTED	16
Overall Study Yoga Intervention	11
Overall Study Physical Therapy Intervention	9
Overall Study Massage Intevention	8
Overall Study Chiropractic Intervention	4
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Community-Engaged Options to Facilitate Opioid Reduction

Baseline characteristics by cohort

Measure	Single Arm Pain Treatment n=16 Participants Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks Non-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	60.4 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants
PROMIS Pain Intensity Scale	68.6 units on a scale STANDARD_DEVIATION 6.5 • n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Participants with pre and post data for analysis

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).

Outcome measures

Measure	Single Arm Pain Treatment n=16 Participants Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks 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 Post	64.4 score on a scale Standard Deviation 6.0
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Rating Pre	68.3 score on a scale Standard Deviation 6.3

PRIMARY outcome

Timeframe: 6 weeks

Population: Participants with pre and post data for analysis

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.

Outcome measures

Measure	Single Arm Pain Treatment n=16 Participants Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks Non-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.
PROMIS Pain Interference Rating Pre	69.9 units on a scale Standard Deviation 5.5
PROMIS Pain Interference Rating Post	64.3 units on a scale Standard Deviation 8.3

SECONDARY outcome

Timeframe: 6 weeks

Population: Participants with pre and post data for analysis

Patient Health Questionnaire (PHQ-8) 8-item scale with score range 0-24 (higher score is worsened depressive symptoms)

Outcome measures

Measure	Single Arm Pain Treatment n=16 Participants Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks Non-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.
Depressive Symptoms Using Patient Health Questionnaire (PHQ-8) Pre	10.7 score on a scale Standard Deviation 5.9
Depressive Symptoms Using Patient Health Questionnaire (PHQ-8) Post	7.6 score on a scale Standard Deviation 5.0

SECONDARY outcome

Timeframe: 6 weeks

Population: Participants with pre and post data for analysis

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).

Outcome measures

Measure	Single Arm Pain Treatment n=16 Participants Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks Non-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.
PROMIS Self-efficacy for Managing Symptoms Short Form 4a Post	41.2 units on a scale Standard Deviation 5.3
PROMIS Self-efficacy for Managing Symptoms Short Form 4a Pre	39.4 units on a scale Standard Deviation 5.2

SECONDARY outcome

Timeframe: 6 weeks

Population: Participants with pre and post data for analysis

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).

Outcome measures

Measure	Single Arm Pain Treatment n=16 Participants Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks Non-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.
PROMIS Self-efficacy for Managing Emotions Short Form 4a Pre	43.4 units on a scale Standard Deviation 6.3
PROMIS Self-efficacy for Managing Emotions Short Form 4a Post	44.4 units on a scale Standard Deviation 5.1

SECONDARY outcome

Timeframe: 6 weeks

Population: Participants with pre and post data for analysis

7-item scale with score range 0-21 (higher score is worsened anxiety)

Outcome measures

Measure	Single Arm Pain Treatment n=16 Participants Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks Non-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.
Anxiety Using Generalized Anxiety Disorder (GAD-7) Pre	5.9 units on a scale Standard Deviation 4.7
Anxiety Using Generalized Anxiety Disorder (GAD-7) Post	5.2 units on a scale Standard Deviation 5.2

SECONDARY outcome

Timeframe: 6 weeks

Population: Participants with pre and post data for analysis

9-item scale asking how one feels about others score range 0-28 (lower score indicates more unmet interpersonal needs)

Outcome measures

Measure	Single Arm Pain Treatment n=16 Participants Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks Non-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.
Interpersonal Needs Questionnaire Pre	27.7 units on a scale Standard Deviation 14.4
Interpersonal Needs Questionnaire Post	24.5 units on a scale Standard Deviation 13.5

SECONDARY outcome

Timeframe: 6 weeks

Population: Participants with pre and post data for analysis

17-item scale to ask about use of opioids (range 0-64 with higher scores indicating more misuse)

Outcome measures

Measure	Single Arm Pain Treatment n=16 Participants Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks Non-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.
Current Opioid Misuse Measure Pre	7.1 units on a scale Standard Deviation 4.9
Current Opioid Misuse Measure Post	6.8 units on a scale Standard Deviation 4.4

SECONDARY outcome

Timeframe: 6 weeks

Population: Participants with pre and post data for analysis

4-items to ask about spiritual well-being (range 4-20 with higher scores indicating more spiritual well-being)

Outcome measures

Measure	Single Arm Pain Treatment n=16 Participants Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks Non-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.
Spiritual Well-being Index Pre	15 units on a scale Standard Deviation 4.1
Spiritual Well-being Index Post	15.1 units on a scale Standard Deviation 3.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Population: All participants

Percentage of scheduled telehealth sessions attended by participants (calculated as total number attended/total number scheduled)

Outcome measures

Measure	Single Arm Pain Treatment n=96 telehealth sessions Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks Non-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.
Percentage of Attendance in Scheduled Telehealth Sessions	95.8 percentage of sessions attended

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Population: Participants with satisfaction data completed - 1 did not participate

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.

Outcome measures

Measure	Single Arm Pain Treatment n=15 Participants Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks Non-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.
IBM Computer Usability and Satisfaction Questionnaires	6.59 mean of summed scores on a scale Standard Deviation 0.62

Adverse Events

Single Arm Pain Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Single Arm Pain Treatment n=16 participants at risk Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks Non-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.
Ear and labyrinth disorders Mild	6.2% 1/16 • Number of events 1 • 6 weeks Severity of event was rated as (select one): Grade 1 - Mild; Grade 2 - Moderate; Grade 3 - Severe Participants were evaluated by RN as to whether there was a reasonable possibility that the experimental COMFORT intervention caused the event.

Additional Information

Marian Wilson

Washington State University

Phone: 509-324-7443

Email: marian.wilson@wsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place