Trial Outcomes & Findings for EMPOWER: Randomized Trial of Online Chronic Pain Management Program to Reduce Reliance on Opioid Analgesic Medications (NCT NCT03308188)
NCT ID: NCT03308188
Last Updated: 2023-09-28
Results Overview
Whether (yes/no) there was a ≥15% decrease in MED, between baseline and 10-month post-randomization follow-up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
402 participants
Primary outcome timeframe
Baseline and 10 months
Results posted on
2023-09-28
Participant Flow
Participant milestones
| Measure |
Treatment As Usual
Participants randomized to Treatment As Usual will receive treatment for chronic pain as typically provided by their clinician -- they will receive no extra treatment from the study.
|
E-Health+
Participants randomized to the E-health+ arm will receive treatment as typically provided by their clinician plus a 4-month subscription to the E-health program, which is an internet based chronic pain program.
E-health program: The Goalistics Chronic Pain Management Program, referred to as the E-health program in EMPOWER, was developed from cognitive, behavioral, interpersonal, and self-management interventions with demonstrated efficacy in traditional face-to-face or group settings. It is patient-centered, having been developed based on substantial input from people with chronic pain and chronic pain professionals.
|
|---|---|---|
|
Overall Study
STARTED
|
202
|
200
|
|
Overall Study
COMPLETED
|
202
|
196
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
| Measure |
Treatment As Usual
Participants randomized to Treatment As Usual will receive treatment for chronic pain as typically provided by their clinician -- they will receive no extra treatment from the study.
|
E-Health+
Participants randomized to the E-health+ arm will receive treatment as typically provided by their clinician plus a 4-month subscription to the E-health program, which is an internet based chronic pain program.
E-health program: The Goalistics Chronic Pain Management Program, referred to as the E-health program in EMPOWER, was developed from cognitive, behavioral, interpersonal, and self-management interventions with demonstrated efficacy in traditional face-to-face or group settings. It is patient-centered, having been developed based on substantial input from people with chronic pain and chronic pain professionals.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Measure Analysis Population Description: The baseline morphine equivalent dose for one participant was an unusable outlier. MED, morphine equivalent dose (Treatment as Usual)
Baseline characteristics by cohort
| Measure |
Treatment As Usual
n=202 Participants
Participants randomized to Treatment As Usual will receive treatment for chronic pain as typically provided by their clinician -- they will receive no extra treatment from the study.
|
E-Health+
n=200 Participants
Participants randomized to the E-health+ arm will receive treatment as typically provided by their clinician plus a 4-month subscription to the E-health program, which is an internet based chronic pain program.
E-health program: The Goalistics Chronic Pain Management Program, referred to as the E-health program in EMPOWER, was developed from cognitive, behavioral, interpersonal, and self-management interventions with demonstrated efficacy in traditional face-to-face or group settings. It is patient-centered, having been developed based on substantial input from people with chronic pain and chronic pain professionals.
|
Total
n=402 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=202 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=402 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
155 Participants
n=202 Participants
|
160 Participants
n=200 Participants
|
315 Participants
n=402 Participants
|
|
Age, Categorical
>=65 years
|
47 Participants
n=202 Participants
|
40 Participants
n=200 Participants
|
87 Participants
n=402 Participants
|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 10.9 • n=202 Participants
|
56.4 years
STANDARD_DEVIATION 11.1 • n=200 Participants
|
56.7 years
STANDARD_DEVIATION 11.0 • n=402 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=202 Participants
|
139 Participants
n=200 Participants
|
279 Participants
n=402 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=202 Participants
|
61 Participants
n=200 Participants
|
123 Participants
n=402 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=202 Participants
|
3 Participants
n=200 Participants
|
5 Participants
n=402 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
189 Participants
n=202 Participants
|
191 Participants
n=200 Participants
|
380 Participants
n=402 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=202 Participants
|
6 Participants
n=200 Participants
|
17 Participants
n=402 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=202 Participants
|
1 Participants
n=200 Participants
|
5 Participants
n=402 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=202 Participants
|
0 Participants
n=200 Participants
|
1 Participants
n=402 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants
|
1 Participants
n=200 Participants
|
1 Participants
n=402 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=202 Participants
|
43 Participants
n=200 Participants
|
72 Participants
n=402 Participants
|
|
Race (NIH/OMB)
White
|
154 Participants
n=202 Participants
|
147 Participants
n=200 Participants
|
301 Participants
n=402 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=202 Participants
|
3 Participants
n=200 Participants
|
6 Participants
n=402 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=202 Participants
|
5 Participants
n=200 Participants
|
16 Participants
n=402 Participants
|
|
Region of Enrollment
United States
|
202 participants
n=202 Participants
|
200 participants
n=200 Participants
|
401 participants
n=402 Participants
|
|
Morphine Equivalent Dose (MED)
|
47.8 Morphine Equivalent Dose
STANDARD_DEVIATION 53.4 • n=201 Participants • Measure Analysis Population Description: The baseline morphine equivalent dose for one participant was an unusable outlier. MED, morphine equivalent dose (Treatment as Usual)
|
48.1 Morphine Equivalent Dose
STANDARD_DEVIATION 63.6 • n=200 Participants • Measure Analysis Population Description: The baseline morphine equivalent dose for one participant was an unusable outlier. MED, morphine equivalent dose (Treatment as Usual)
|
48.0 Morphine Equivalent Dose
STANDARD_DEVIATION 58.6 • n=401 Participants • Measure Analysis Population Description: The baseline morphine equivalent dose for one participant was an unusable outlier. MED, morphine equivalent dose (Treatment as Usual)
|
|
Pain Intensity
|
5.9 Score on a scale
STANDARD_DEVIATION 1.6 • n=202 Participants
|
5.9 Score on a scale
STANDARD_DEVIATION 1.5 • n=200 Participants
|
5.9 Score on a scale
STANDARD_DEVIATION 1.6 • n=402 Participants
|
PRIMARY outcome
Timeframe: Baseline and 10 monthsPopulation: Three participants withdrew consent. (E-Health) One participant died. (E-Health) The baseline morphine equivalent dose for one participant was an unusable outlier. MED, morphine equivalent dose (Treatment as Usual)
Whether (yes/no) there was a ≥15% decrease in MED, between baseline and 10-month post-randomization follow-up.
Outcome measures
| Measure |
Treatment As Usual
n=201 Participants
Participants randomized to Treatment As Usual will receive treatment for chronic pain as typically provided by their clinician -- they will receive no extra treatment from the study.
|
E-Health+
n=196 Participants
Participants randomized to the E-health+ arm will receive treatment as typically provided by their clinician plus a 4-month subscription to the E-health program, which is an internet based chronic pain program.
E-health program: The Goalistics Chronic Pain Management Program, referred to as the E-health program in EMPOWER, was developed from cognitive, behavioral, interpersonal, and self-management interventions with demonstrated efficacy in traditional face-to-face or group settings. It is patient-centered, having been developed based on substantial input from people with chronic pain and chronic pain professionals.
|
|---|---|---|
|
Decrease in Morphine Equivalent Dose (MED)
|
85 Participants
|
105 Participants
|
SECONDARY outcome
Timeframe: Baseline and 10 monthsPopulation: Three participants withdrew consent. (E-Health) One participant died. (E-Health) The baseline morphine equivalent dose for one participant was an unusable outlier. MED, morphine equivalent dose (Treatment as Usual)
Whether (yes/no) there is a clinically meaningful decrease in pain intensity (at least 2 points) as measured by the Brief Pain Inventory (BPI), between baseline and 10-month post-randomization follow-up.
Outcome measures
| Measure |
Treatment As Usual
n=201 Participants
Participants randomized to Treatment As Usual will receive treatment for chronic pain as typically provided by their clinician -- they will receive no extra treatment from the study.
|
E-Health+
n=196 Participants
Participants randomized to the E-health+ arm will receive treatment as typically provided by their clinician plus a 4-month subscription to the E-health program, which is an internet based chronic pain program.
E-health program: The Goalistics Chronic Pain Management Program, referred to as the E-health program in EMPOWER, was developed from cognitive, behavioral, interpersonal, and self-management interventions with demonstrated efficacy in traditional face-to-face or group settings. It is patient-centered, having been developed based on substantial input from people with chronic pain and chronic pain professionals.
|
|---|---|---|
|
Pain Intensity
|
13 Participants
|
24 Participants
|
Adverse Events
Treatment As Usual
Serious events: 0 serious events
Other events: 95 other events
Deaths: 0 deaths
E-Health+
Serious events: 0 serious events
Other events: 85 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment As Usual
n=202 participants at risk
Participants randomized to Treatment As Usual will receive treatment for chronic pain as typically provided by their clinician -- they will receive no extra treatment from the study.
|
E-Health+
n=200 participants at risk
Participants randomized to the E-health+ arm will receive treatment as typically provided by their clinician plus a 4-month subscription to the E-health program, which is an internet based chronic pain program.
E-health program: The Goalistics Chronic Pain Management Program, referred to as the E-health program in EMPOWER, was developed from cognitive, behavioral, interpersonal, and self-management interventions with demonstrated efficacy in traditional face-to-face or group settings. It is patient-centered, having been developed based on substantial input from people with chronic pain and chronic pain professionals.
|
|---|---|---|
|
General disorders
Worsening of Pain Intensity
|
10.4%
21/202 • Randomization through Month 10
A potential AE is defined as \>30% symptom deterioration from baseline as indicated by any of the following: 1) Pain Intensity score or Pain Interference score as measured by the BPI; 2) Depression, Anxiety, or Stress score from the DASS-21. Additionally, to meet criteria for an AE, these follow-up scores must fall within at least the "moderate" range of severity for the respective measures. A report identifying participants with AEs defined as above was generated on a weekly basis.
|
9.0%
18/200 • Randomization through Month 10
A potential AE is defined as \>30% symptom deterioration from baseline as indicated by any of the following: 1) Pain Intensity score or Pain Interference score as measured by the BPI; 2) Depression, Anxiety, or Stress score from the DASS-21. Additionally, to meet criteria for an AE, these follow-up scores must fall within at least the "moderate" range of severity for the respective measures. A report identifying participants with AEs defined as above was generated on a weekly basis.
|
|
General disorders
Worsening of Pain Interference
|
17.3%
35/202 • Randomization through Month 10
A potential AE is defined as \>30% symptom deterioration from baseline as indicated by any of the following: 1) Pain Intensity score or Pain Interference score as measured by the BPI; 2) Depression, Anxiety, or Stress score from the DASS-21. Additionally, to meet criteria for an AE, these follow-up scores must fall within at least the "moderate" range of severity for the respective measures. A report identifying participants with AEs defined as above was generated on a weekly basis.
|
14.5%
29/200 • Randomization through Month 10
A potential AE is defined as \>30% symptom deterioration from baseline as indicated by any of the following: 1) Pain Intensity score or Pain Interference score as measured by the BPI; 2) Depression, Anxiety, or Stress score from the DASS-21. Additionally, to meet criteria for an AE, these follow-up scores must fall within at least the "moderate" range of severity for the respective measures. A report identifying participants with AEs defined as above was generated on a weekly basis.
|
|
Psychiatric disorders
Worsening of Depression
|
18.3%
37/202 • Randomization through Month 10
A potential AE is defined as \>30% symptom deterioration from baseline as indicated by any of the following: 1) Pain Intensity score or Pain Interference score as measured by the BPI; 2) Depression, Anxiety, or Stress score from the DASS-21. Additionally, to meet criteria for an AE, these follow-up scores must fall within at least the "moderate" range of severity for the respective measures. A report identifying participants with AEs defined as above was generated on a weekly basis.
|
15.0%
30/200 • Randomization through Month 10
A potential AE is defined as \>30% symptom deterioration from baseline as indicated by any of the following: 1) Pain Intensity score or Pain Interference score as measured by the BPI; 2) Depression, Anxiety, or Stress score from the DASS-21. Additionally, to meet criteria for an AE, these follow-up scores must fall within at least the "moderate" range of severity for the respective measures. A report identifying participants with AEs defined as above was generated on a weekly basis.
|
|
Psychiatric disorders
Worsening of Anxiety
|
17.8%
36/202 • Randomization through Month 10
A potential AE is defined as \>30% symptom deterioration from baseline as indicated by any of the following: 1) Pain Intensity score or Pain Interference score as measured by the BPI; 2) Depression, Anxiety, or Stress score from the DASS-21. Additionally, to meet criteria for an AE, these follow-up scores must fall within at least the "moderate" range of severity for the respective measures. A report identifying participants with AEs defined as above was generated on a weekly basis.
|
19.5%
39/200 • Randomization through Month 10
A potential AE is defined as \>30% symptom deterioration from baseline as indicated by any of the following: 1) Pain Intensity score or Pain Interference score as measured by the BPI; 2) Depression, Anxiety, or Stress score from the DASS-21. Additionally, to meet criteria for an AE, these follow-up scores must fall within at least the "moderate" range of severity for the respective measures. A report identifying participants with AEs defined as above was generated on a weekly basis.
|
|
Psychiatric disorders
Worsening of Stress
|
9.9%
20/202 • Randomization through Month 10
A potential AE is defined as \>30% symptom deterioration from baseline as indicated by any of the following: 1) Pain Intensity score or Pain Interference score as measured by the BPI; 2) Depression, Anxiety, or Stress score from the DASS-21. Additionally, to meet criteria for an AE, these follow-up scores must fall within at least the "moderate" range of severity for the respective measures. A report identifying participants with AEs defined as above was generated on a weekly basis.
|
11.5%
23/200 • Randomization through Month 10
A potential AE is defined as \>30% symptom deterioration from baseline as indicated by any of the following: 1) Pain Intensity score or Pain Interference score as measured by the BPI; 2) Depression, Anxiety, or Stress score from the DASS-21. Additionally, to meet criteria for an AE, these follow-up scores must fall within at least the "moderate" range of severity for the respective measures. A report identifying participants with AEs defined as above was generated on a weekly basis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place