Chronic Pain, Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALEmpowered 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.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age at least 18 years old * Chronic Pain (\> 3 months) * Taking Methadone or Buprenorphine * English Fluency
Exclusion criteria
* Pregnant, * Gross Cognitive Impairment, * Acute Suicidality, * Severe Depression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Usefulness | once immediately after class | How useful was the information presented in the class? (a single item, 0-10 scale, higher scores correspond to greater perceived usefulness). |
| Likelihood of Using the Skills | 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) |
| Participant Satisfaction | once immediately after class | Please rate your overall satisfaction with the class (a Single Item, 0-10 Scale, higher scores correspond to greater satisfaction). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Bothersomeness | 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) |
| PCS Total Scores | 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. |
| Pain Intensity | 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) |
| PROMIS-Sleep Disturbance | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| PROMIS-Physical Function | 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 |
| PROMIS-Anxiety | 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 |
| PROMIS-Depression | 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 |
| Global Impression of Change | At 1 month post-tx | The global impression of change (a single item, 1-7 scale, higher scores correspond to greater improvement) |
| Craving | At 1 month post-tx | How much do you crave opiates now? (single item, 0-10 scale, higher scores correspond to greater craving) |
| PROMIS-Pain Interference | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | Empowered Relief |
|---|---|
| Age, Continuous | 49.36 Years STANDARD_DEVIATION 12.21 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Sex/Gender, Customized Decline/missing | 3 Participants |
| Sex/Gender, Customized Female | 30 Participants |
| Sex/Gender, Customized Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 18 / 55 |
| serious Total, serious adverse events | 0 / 55 |
Outcome results
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)
Time frame: once immediately after class
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empowered Relief | Likelihood of Using the Skills | 8.47 score on a scale | Standard Deviation 2.14 |
Primary
Participant Satisfaction
Please rate your overall satisfaction with the class (a Single Item, 0-10 Scale, higher scores correspond to greater satisfaction).
Time frame: once immediately after class
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empowered Relief | Participant Satisfaction | 8.59 score on a scale | Standard Deviation 1.96 |
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).
Time frame: once immediately after class
Population: class attenders
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empowered Relief | Perceived Usefulness | 8.25 score on a scale | Standard Deviation 2.34 |
Secondary
Pain Bothersomeness
How bothersome your pain had been during the previous week? (a Single Item, 0-10 Scale, higher scores greater bothersomeness)
Time frame: At 1 month post-tx
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empowered Relief | Pain Bothersomeness | 5.9 score on a scale | Standard Deviation 1.98 |
p-value: <0.00195% CI: [0.53, 1.55]t-test, 2 sided
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)
Time frame: At 1 month post-tx
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empowered Relief | Pain Intensity | 5.58 score on a scale | Standard Deviation 1.7 |
p-value: <0.00195% CI: [0.52, 1.2]t-test, 2 sided
Secondary
PCS Total Scores
The 13-item Pain Catastrophizing Scale total score ranges from 0 to 52, higher scores correspond to greater pain catastrophizing.
Time frame: At 1 month post-tx
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empowered Relief | PCS Total Scores | 19.02 score on a scale | Standard Deviation 11.35 |
p-value: 0.20895% CI: [-1.42, 3.37]t-test, 2 sided
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
Time frame: At 1 month post-tx
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empowered Relief | PROMIS-Sleep Disturbance | 57.31 T-scores | Standard Deviation 8.69 |
p-value: 0.32895% CI: [-0.84, 2.47]t-test, 1 sided
Other Pre-specified
Craving
How much do you crave opiates now? (single item, 0-10 scale, higher scores correspond to greater craving)
Time frame: At 1 month post-tx
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empowered Relief | Craving | 2.43 score on a scale | Standard Deviation 2.95 |
Comparison: paired sample t testp-value: 0.3795% CI: [-0.34, 0.89]t-test, 2 sided
p-value: 0.3795% CI: [-0.34, 0.89]t-test, 2 sided
Other Pre-specified
Global Impression of Change
The global impression of change (a single item, 1-7 scale, higher scores correspond to greater improvement)
Time frame: At 1 month post-tx
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empowered Relief | Global Impression of Change | 4.36 score on a scale | Standard Deviation 0.78 |
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
Time frame: At 1 month post-tx
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empowered Relief | PROMIS-Anxiety | 58.23 T-scores | Standard Deviation 7.96 |
p-value: 0.83295% CI: [-2.46, 1.99]t-test, 2 sided
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
Time frame: At 1 month post-tx
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empowered Relief | PROMIS-Depression | 57.38 T-scores | Standard Deviation 9.07 |
p-value: 0.48695% CI: [-1.22, 2.53]t-test, 1 sided
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
Time frame: At 1 month post-tx
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empowered Relief | PROMIS-Pain Interference | 64.69 T-scores | Standard Deviation 4.89 |
p-value: <0.00195% CI: [1.26, 4.16]t-test, 1 sided
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
Time frame: At 1 month post-tx
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empowered Relief | PROMIS-Physical Function | 35.91 T-scores | Standard Deviation 5.58 |
p-value: 0.3495% CI: [-1.33, 0.47]t-test, 2 sided