Trial Outcomes & Findings for Virtual Empowered Relief for Chronic Pain (NCT NCT05057988)

NCT ID: NCT05057988

Last Updated: 2025-04-16

Results Overview

How useful was the information presented in the class? (a single item, 0-10 scale, higher scores correspond to greater perceived usefulness).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 73 participants
• Primary outcome timeframe: once immediately after class
• Results posted on: 2025-04-16

Participant Flow

Participant milestones

Measure	Empowered Relief Empowered Relief class: The participants will attend the Empowered Relief class online via Zoom. The class includes pain neuroscience education, as well as cognition, emotion, and physiologic self-regulation for people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.
Overall Study STARTED	55
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

missing 2

Baseline characteristics by cohort

Measure	Empowered Relief n=55 Participants Empowered Relief class: The participants will attend the Empowered Relief class online via Zoom. The class includes pain neuroscience education, as well as cognition, emotion, and physiologic self-regulation for people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.
Age, Continuous	49.36 Years STANDARD_DEVIATION 12.21 • n=53 Participants • missing 2
Sex/Gender, Customized Female	30 Participants n=55 Participants
Sex/Gender, Customized Male	22 Participants n=55 Participants
Sex/Gender, Customized Decline/missing	3 Participants n=55 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=55 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=55 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=55 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=55 Participants
Race (NIH/OMB) Asian	0 Participants n=55 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=55 Participants
Race (NIH/OMB) Black or African American	8 Participants n=55 Participants
Race (NIH/OMB) White	40 Participants n=55 Participants
Race (NIH/OMB) More than one race	2 Participants n=55 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=55 Participants

PRIMARY outcome

Timeframe: once immediately after class

Population: class attenders

How useful was the information presented in the class? (a single item, 0-10 scale, higher scores correspond to greater perceived usefulness).

Outcome measures

Measure

Empowered Relief n=51 Participants Empowered Relief class: The participants will attend the Empowered Relief class online via Zoom. The class includes pain neuroscience education, as well as cognition, emotion, and physiologic self-regulation for people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.

Perceived Usefulness

8.25 score on a scale Standard Deviation 2.34

PRIMARY outcome

Timeframe: once immediately after class

Please rate your overall satisfaction with the class (a Single Item, 0-10 Scale, higher scores correspond to greater satisfaction).

Outcome measures

Measure

Empowered Relief n=51 Participants Empowered Relief class: The participants will attend the Empowered Relief class online via Zoom. The class includes pain neuroscience education, as well as cognition, emotion, and physiologic self-regulation for people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.

Participant Satisfaction

8.59 score on a scale Standard Deviation 1.96

PRIMARY outcome

Timeframe: once immediately after class

How likely are you to use the skills and information you learned? (a Single Item, 0-10 Scale, higher scores correspond to greater likelihood)

Outcome measures

Measure

Empowered Relief n=51 Participants Empowered Relief class: The participants will attend the Empowered Relief class online via Zoom. The class includes pain neuroscience education, as well as cognition, emotion, and physiologic self-regulation for people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.

Likelihood of Using the Skills

8.47 score on a scale Standard Deviation 2.14

SECONDARY outcome

Timeframe: At 1 month post-tx

How "bothersome" your pain had been during the previous week? (a Single Item, 0-10 Scale, higher scores greater bothersomeness)

Outcome measures

Measure

Empowered Relief n=50 Participants Empowered Relief class: The participants will attend the Empowered Relief class online via Zoom. The class includes pain neuroscience education, as well as cognition, emotion, and physiologic self-regulation for people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.

Pain Bothersomeness

5.9 score on a scale Standard Deviation 1.98

SECONDARY outcome

Timeframe: At 1 month post-tx

The 13-item Pain Catastrophizing Scale total score ranges from 0 to 52, higher scores correspond to greater pain catastrophizing.

Outcome measures

Measure

Empowered Relief n=47 Participants Empowered Relief class: The participants will attend the Empowered Relief class online via Zoom. The class includes pain neuroscience education, as well as cognition, emotion, and physiologic self-regulation for people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.

PCS Total Scores

19.02 score on a scale Standard Deviation 11.35

SECONDARY outcome

Timeframe: At 1 month post-tx

How would you rate your pain on average in the past 7 days? (a single item, 0-10 scale, higher scores correspond to greater pain intensity)

Outcome measures

Measure

Empowered Relief n=50 Participants Empowered Relief class: The participants will attend the Empowered Relief class online via Zoom. The class includes pain neuroscience education, as well as cognition, emotion, and physiologic self-regulation for people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.

Pain Intensity

5.58 score on a scale Standard Deviation 1.70

SECONDARY outcome

Timeframe: At 1 month post-tx

PROMIS-Sleep Disturbance short form T scores Mean = 50, SD = 10 Higher scores indicate worse symptoms 70T or higher considers severe symptoms

Outcome measures

Measure

Empowered Relief n=47 Participants Empowered Relief class: The participants will attend the Empowered Relief class online via Zoom. The class includes pain neuroscience education, as well as cognition, emotion, and physiologic self-regulation for people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.

PROMIS-Sleep Disturbance

57.31 T-scores Standard Deviation 8.69

OTHER_PRE_SPECIFIED outcome

Timeframe: At 1 month post-tx

PROMIS-Pain Interference short form T scores Mean = 50, SD = 10 Higher scores indicate worse symptoms 70T or higher considers severe symptoms

Outcome measures

Measure

Empowered Relief n=47 Participants Empowered Relief class: The participants will attend the Empowered Relief class online via Zoom. The class includes pain neuroscience education, as well as cognition, emotion, and physiologic self-regulation for people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.

PROMIS-Pain Interference

64.69 T-scores Standard Deviation 4.89

OTHER_PRE_SPECIFIED outcome

Timeframe: At 1 month post-tx

PROMIS-Depression short form T scores Mean = 50, SD = 10 Higher scores indicate worse symptoms 70T or higher considers severe symptoms

Outcome measures

Measure

Empowered Relief n=47 Participants Empowered Relief class: The participants will attend the Empowered Relief class online via Zoom. The class includes pain neuroscience education, as well as cognition, emotion, and physiologic self-regulation for people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.

PROMIS-Depression

57.38 T-scores Standard Deviation 9.07

OTHER_PRE_SPECIFIED outcome

Timeframe: At 1 month post-tx

PROMIS-Anxiety short form T scores Mean = 50, SD = 10 Higher scores indicate worse symptoms 70T or higher considers severe symptoms

Outcome measures

Measure

Empowered Relief n=47 Participants Empowered Relief class: The participants will attend the Empowered Relief class online via Zoom. The class includes pain neuroscience education, as well as cognition, emotion, and physiologic self-regulation for people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.

PROMIS-Anxiety

58.23 T-scores Standard Deviation 7.96

OTHER_PRE_SPECIFIED outcome

Timeframe: At 1 month post-tx

PROMIS-Physical Function short form T Scores Mean = 50, SD = 10 Higher scores indicate better function 30T or higher considers severe impairment

Outcome measures

Measure

Empowered Relief n=47 Participants Empowered Relief class: The participants will attend the Empowered Relief class online via Zoom. The class includes pain neuroscience education, as well as cognition, emotion, and physiologic self-regulation for people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.

PROMIS-Physical Function

35.91 T-scores Standard Deviation 5.58

OTHER_PRE_SPECIFIED outcome

Timeframe: At 1 month post-tx

The global impression of change (a single item, 1-7 scale, higher scores correspond to greater improvement)

Outcome measures

Measure

Empowered Relief n=49 Participants Empowered Relief class: The participants will attend the Empowered Relief class online via Zoom. The class includes pain neuroscience education, as well as cognition, emotion, and physiologic self-regulation for people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.

Global Impression of Change

4.36 score on a scale Standard Deviation 0.78

OTHER_PRE_SPECIFIED outcome

Timeframe: At 1 month post-tx

How much do you crave opiates now? (single item, 0-10 scale, higher scores correspond to greater craving)

Outcome measures

Measure

Empowered Relief n=47 Participants Empowered Relief class: The participants will attend the Empowered Relief class online via Zoom. The class includes pain neuroscience education, as well as cognition, emotion, and physiologic self-regulation for people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.

Craving

2.43 score on a scale Standard Deviation 2.95

Adverse Events

Empowered Relief

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Empowered Relief n=55 participants at risk Empowered Relief class: The participants will attend the Empowered Relief class online via Zoom. The class includes pain neuroscience education, as well as cognition, emotion, and physiologic self-regulation for people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.
Infections and infestations COVID	7.3% 4/55 • Number of events 6 • 3 months None were reported serious adverse events, no one died
Surgical and medical procedures Surgery	7.3% 4/55 • Number of events 4 • 3 months None were reported serious adverse events, no one died
General disorders Fall	7.3% 4/55 • Number of events 4 • 3 months None were reported serious adverse events, no one died
Infections and infestations Flu/Cold	5.5% 3/55 • Number of events 3 • 3 months None were reported serious adverse events, no one died
Injury, poisoning and procedural complications Injury/Sprain	5.5% 3/55 • Number of events 3 • 3 months None were reported serious adverse events, no one died

Additional Information

Dr. Dokyoung Sophia You

Stanford University

Phone: 650-724-9320

Email: dsyou@stanford.edu

Results disclosure agreements

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