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The purpose of the current pilot study is to examine a feasibility and the preliminary efficacy of Empowered Relief (ER) class when it is delivered 'virtually' to patients with chronic pain who take methadone or buprenorphine. The ER class is a single-session pain management class, which has demonstrated to be effective in improving pain and pain-related distress in patients with chronic low back pain, but its efficacy has not been examined in patients with chronic pain who take methadone or buprenorphine. Class participants will learn self-regulatory skills and develop a personalized plan to use the skills every day. The current study will examine a feasibility and participant's perception and satisfaction of this class at post-class. The study will also follow participants 3 months by administering 5 surveys (baseline, 2 weeks and 1 month, 2 months, and 3 months post-treatment) to determine whether the class confers the short-term and medium-term benefits across various aspects of health.
Some patients with chronic pain are on long-term opioid therapy. Methadone and buprenorphine are often used in long-term opioid therapy for chronic pain. Additionally, chronic pain is highly prevalent in people receiving methadone or buprenorphine for opioid use disorder (MOUD). It is observed that up to 68% of people with MOUD have chronic pain condition. Therefore, a large number of people taking methadone or buprenorphine will suffer from chronic pain, but they frequently face limited availability of clinicians offering non-pharmacological pain management programs. Thus, a brief internet-based pain relief skills program may be one option that can overcome such treatment barrier. A recent randomized control trial on patients with chronic low back pain has demonstrated that a single-session, 2-hour, pain management class (Empowered Relief; ER) was effective to improve pain and pain-related distress. The ER class consists of pain neuroscience education and self-regulatory skills. While the ER is a promising and scalable option, it is not yet tested in patients with chronic pain who take methadone or buprenorphine. The current proposed, single-arm, uncontrolled pilot project will determine a) a feasibility in this patient population, b) patients' perceptions and satisfaction of the ER class and c) preliminary efficacy to inform the design of a future, larger, controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empowered Relief | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empowered Relief class | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Usefulness | How useful was the information presented in the class? (a single item, 0-10 scale, higher scores correspond to greater perceived usefulness). | once immediately after class |
| Participant Satisfaction | Please rate your overall satisfaction with the class (a Single Item, 0-10 Scale, higher scores correspond to greater satisfaction). | once immediately after class |
| Likelihood of Using the Skills | How likely are you to use the skills and information you learned? (a Single Item, 0-10 Scale, higher scores correspond to greater likelihood) | once immediately after class |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Bothersomeness | How "bothersome" your pain had been during the previous week? (a Single Item, 0-10 Scale, higher scores greater bothersomeness) | At 1 month post-tx |
| PCS Total Scores | The 13-item Pain Catastrophizing Scale total score ranges from 0 to 52, higher scores correspond to greater pain catastrophizing. |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS-Pain Interference | PROMIS-Pain Interference short form T scores Mean = 50, SD = 10 Higher scores indicate worse symptoms 70T or higher considers severe symptoms | At 1 month post-tx |
| PROMIS-Depression |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Pain Relief Innovations Lab | Palo Alto | California | 27604 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34398206 | Background | Darnall BD, Roy A, Chen AL, Ziadni MS, Keane RT, You DS, Slater K, Poupore-King H, Mackey I, Kao MC, Cook KF, Lorig K, Zhang D, Hong J, Tian L, Mackey SC. Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2113401. doi: 10.1001/jamanetworkopen.2021.13401. | |
| 24851056 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | missing 2 |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Perceived Usefulness | How useful was the information presented in the class? (a single item, 0-10 scale, higher scores correspond to greater perceived usefulness). | class attenders | Posted | Mean | Standard Deviation | score on a scale | once immediately after class |
|
3 months
None were reported serious adverse events, no one died
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dokyoung Sophia You | Stanford University | 650-724-9320 | dsyou@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 10, 2024 | Mar 27, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2024 | Mar 27, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Single intervention
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|
| At 1 month post-tx |
| Pain Intensity | 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) | At 1 month post-tx |
| PROMIS-Sleep Disturbance | PROMIS-Sleep Disturbance short form T scores Mean = 50, SD = 10 Higher scores indicate worse symptoms 70T or higher considers severe symptoms | 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
| At 1 month post-tx |
| PROMIS-Anxiety | PROMIS-Anxiety short form T scores Mean = 50, SD = 10 Higher scores indicate worse symptoms 70T or higher considers severe symptoms | At 1 month post-tx |
| PROMIS-Physical Function | PROMIS-Physical Function short form T Scores Mean = 50, SD = 10 Higher scores indicate better function 30T or higher considers severe impairment | At 1 month post-tx |
| Global Impression of Change | The global impression of change (a single item, 1-7 scale, higher scores correspond to greater improvement) | At 1 month post-tx |
| Craving | How much do you crave opiates now? (single item, 0-10 scale, higher scores correspond to greater craving) | At 1 month post-tx |
| Background |
| Darnall BD, Sturgeon JA, Kao MC, Hah JM, Mackey SC. From Catastrophizing to Recovery: a pilot study of a single-session treatment for pain catastrophizing. J Pain Res. 2014 Apr 25;7:219-26. doi: 10.2147/JPR.S62329. eCollection 2014. |
| 34022930 | Background | Ziadni MS, Anderson SR, Gonzalez-Castro L, Darnall BD. Comparative efficacy of a single-session "Empowered Relief" videoconference-delivered group intervention for chronic pain: study protocol for a randomized controlled trial. Trials. 2021 May 22;22(1):358. doi: 10.1186/s13063-021-05303-8. |
| 38843513 | Background | Klein MR, Darnall BD, You DS. Feasibility of Web-Based Single-Session Empowered Relief in Patients With Chronic Pain Taking Methadone or Buprenorphine: Protocol for a Single-Arm Trial. JMIR Res Protoc. 2024 Jun 6;13:e53784. doi: 10.2196/53784. |
| Standard Deviation |
| Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Participant Satisfaction | Please rate your overall satisfaction with the class (a Single Item, 0-10 Scale, higher scores correspond to greater satisfaction). | Posted | Mean | Standard Deviation | score on a scale | once immediately after class |
|
|
|
| Primary | Likelihood of Using the Skills | How likely are you to use the skills and information you learned? (a Single Item, 0-10 Scale, higher scores correspond to greater likelihood) | Posted | Mean | Standard Deviation | score on a scale | once immediately after class |
|
|
|
| Secondary | Pain Bothersomeness | How "bothersome" your pain had been during the previous week? (a Single Item, 0-10 Scale, higher scores greater bothersomeness) | Posted | Mean | Standard Deviation | score on a scale | At 1 month post-tx |
|
|
|
|
| Secondary | PCS Total Scores | The 13-item Pain Catastrophizing Scale total score ranges from 0 to 52, higher scores correspond to greater pain catastrophizing. | Posted | Mean | Standard Deviation | score on a scale | At 1 month post-tx |
|
|
|
|
| Secondary | Pain Intensity | 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) | Posted | Mean | Standard Deviation | score on a scale | At 1 month post-tx |
|
|
|
|
| Secondary | PROMIS-Sleep Disturbance | PROMIS-Sleep Disturbance short form T scores Mean = 50, SD = 10 Higher scores indicate worse symptoms 70T or higher considers severe symptoms | Posted | Mean | Standard Deviation | T-scores | At 1 month post-tx |
|
|
|
|
| Other Pre-specified | PROMIS-Pain Interference | PROMIS-Pain Interference short form T scores Mean = 50, SD = 10 Higher scores indicate worse symptoms 70T or higher considers severe symptoms | Posted | Mean | Standard Deviation | T-scores | At 1 month post-tx |
|
|
|
|
| Other Pre-specified | PROMIS-Depression | PROMIS-Depression short form T scores Mean = 50, SD = 10 Higher scores indicate worse symptoms 70T or higher considers severe symptoms | Posted | Mean | Standard Deviation | T-scores | At 1 month post-tx |
|
|
|
|
| Other Pre-specified | PROMIS-Anxiety | PROMIS-Anxiety short form T scores Mean = 50, SD = 10 Higher scores indicate worse symptoms 70T or higher considers severe symptoms | Posted | Mean | Standard Deviation | T-scores | At 1 month post-tx |
|
|
|
|
| Other Pre-specified | PROMIS-Physical Function | PROMIS-Physical Function short form T Scores Mean = 50, SD = 10 Higher scores indicate better function 30T or higher considers severe impairment | Posted | Mean | Standard Deviation | T-scores | At 1 month post-tx |
|
|
|
|
| Other Pre-specified | Global Impression of Change | The global impression of change (a single item, 1-7 scale, higher scores correspond to greater improvement) | Posted | Mean | Standard Deviation | score on a scale | At 1 month post-tx |
|
|
|
| Other Pre-specified | Craving | How much do you crave opiates now? (single item, 0-10 scale, higher scores correspond to greater craving) | Posted | Mean | Standard Deviation | score on a scale | At 1 month post-tx |
|
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 18 |
| 55 |
| Surgery | Surgical and medical procedures | Systematic Assessment |
|
| Fall | General disorders | Systematic Assessment |
|
| Flu/Cold | Infections and infestations | Systematic Assessment |
|
| Injury/Sprain | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| .370 |
| Mean Difference (Net) |
| .28 |
| Standard Deviation |
| 2.09 |
| 2-Sided |
| 95 |
| -.34 |
| .89 |
| Other |
Paired T test |