Trial Outcomes & Findings for Pain Reduction Through Empowered Recovery (PRIME) Study (NCT NCT05619510)
NCT ID: NCT05619510
Last Updated: 2026-08-11
Results Overview
Pain Intensity was measured by the Patient-Reported Outcomes Measurement Information System . Pain intensity measure. Patient-Reported Outcomes Measurement Information System . Survey uses a standardized T-score metric based on a mean of 50 and a standard deviation of 10. Higher score worse pain.
TERMINATED
NA
9 participants
Baseline and 12 weeks
2026-08-11
Participant Flow
Participants were recruited for the study through community partners, including churches, and senior day centers, and Johns Hopkins MyChart. Investigators also recruited through word of mouth and previous research studies.
Participant milestones
| Measure |
Wait List Control Group
This group will be randomized to wait list control. They will serve as a control for the intervention at time points 1 and 2. However after a 2-3 month period they will receive the intervention.
|
Intervention Group
Individuals randomized to this group will start the intervention immediately and have outcomes measured at three time points.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pain Reduction Through Empowered Recovery (PRIME) Study
Baseline characteristics by cohort
| Measure |
Wait List Control Group
n=5 Participants
This group will be randomized to wait list control. They will serve as a control for the intervention at time points 1 and 2. However after a 2-3 month period they will receive the intervention.
|
Intervention Group
n=4 Participants
Individuals randomized to this group will start the intervention immediately and have outcomes measured at three time points.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.04 years
STANDARD_DEVIATION 2.01 • n=54 Participants
|
61.28 years
STANDARD_DEVIATION 3.06 • n=54 Participants
|
62.81 years
STANDARD_DEVIATION 2.77 • n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=54 Participants
|
4 Participants
n=54 Participants
|
9 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=54 Participants
|
2 Participants
n=54 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPain Intensity was measured by the Patient-Reported Outcomes Measurement Information System . Pain intensity measure. Patient-Reported Outcomes Measurement Information System . Survey uses a standardized T-score metric based on a mean of 50 and a standard deviation of 10. Higher score worse pain.
Outcome measures
| Measure |
Intervention Group
n=4 Participants
Individuals randomized to this group will start the intervention immediately and have outcomes measured at three time points.
|
Wait List Control Group
n=5 Participants
This group will be randomized to wait list control. They will serve as a control for the intervention at time points 1 and 2. However after a 2-3 month period they will receive the intervention.
|
|---|---|---|
|
Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System Pain Intensity Measure
Baseline
|
66.18 T Scores
Standard Deviation 11.60
|
61.36 T Scores
Standard Deviation 1.79
|
|
Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System Pain Intensity Measure
12 weeks
|
65.33 T Scores
Standard Deviation 4.66
|
61.26 T Scores
Standard Deviation 1.94
|
PRIMARY outcome
Timeframe: Baseline and 12 weeks.Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference is a 6 question measure with a range of 0-100 with a higher score indicating increased pain interference.
Outcome measures
| Measure |
Intervention Group
n=4 Participants
Individuals randomized to this group will start the intervention immediately and have outcomes measured at three time points.
|
Wait List Control Group
n=5 Participants
This group will be randomized to wait list control. They will serve as a control for the intervention at time points 1 and 2. However after a 2-3 month period they will receive the intervention.
|
|---|---|---|
|
Pain Interference as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)
Baseline
|
66.05 score on a scale
Standard Deviation 4.87
|
63.90 score on a scale
Standard Deviation 1.60
|
|
Pain Interference as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)
12 weeks
|
64.10 score on a scale
Standard Deviation 2.46
|
64.28 score on a scale
Standard Deviation 2.44
|
PRIMARY outcome
Timeframe: Baseline and 12 weeks.Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference is a 20 question measure with a range of 20-100 with a higher score indicating increased pain behaviors
Outcome measures
| Measure |
Intervention Group
n=4 Participants
Individuals randomized to this group will start the intervention immediately and have outcomes measured at three time points.
|
Wait List Control Group
n=5 Participants
This group will be randomized to wait list control. They will serve as a control for the intervention at time points 1 and 2. However after a 2-3 month period they will receive the intervention.
|
|---|---|---|
|
Pain Behavior as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)Pain Behavior Measure
Baseline
|
65.02 score on a scale
Standard Deviation 1.67
|
65.03 score on a scale
Standard Deviation 1.69
|
|
Pain Behavior as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)Pain Behavior Measure
12 weeks
|
63.78 score on a scale
Standard Deviation 2.56
|
62.70 score on a scale
Standard Deviation 1.61
|
PRIMARY outcome
Timeframe: Baseline and 12 weeks.The Patient Health Questionnaire 9 (PHQ9) measures depressive symptoms. The score range is 0-27 with a higher score indicating more severe depression.
Outcome measures
| Measure |
Intervention Group
n=4 Participants
Individuals randomized to this group will start the intervention immediately and have outcomes measured at three time points.
|
Wait List Control Group
n=5 Participants
This group will be randomized to wait list control. They will serve as a control for the intervention at time points 1 and 2. However after a 2-3 month period they will receive the intervention.
|
|---|---|---|
|
Depression as Assessed by the Patient Health Questionnaire 9 (PHQ9)
Baseline
|
11.40 score on a scale
Standard Deviation 1.57
|
10.5 score on a scale
Standard Deviation 3.32
|
|
Depression as Assessed by the Patient Health Questionnaire 9 (PHQ9)
12 weeks
|
9.40 score on a scale
Standard Deviation 0.93
|
8.33 score on a scale
Standard Deviation 2.60
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksThe Patient Reported Outcomes Measurement System (PROMIS)57 the Patient Reported Outcomes Measurement Information System (PROMIS) 57, which is includes an 8-item instrument that can be used to measure self-reported negative mood, view of self, and somatic symptoms. The score range for PROMIS 57 is 8-40. Higher scores indicate more depressive symptoms, which is a worse outcome.
Outcome measures
| Measure |
Intervention Group
n=4 Participants
Individuals randomized to this group will start the intervention immediately and have outcomes measured at three time points.
|
Wait List Control Group
n=5 Participants
This group will be randomized to wait list control. They will serve as a control for the intervention at time points 1 and 2. However after a 2-3 month period they will receive the intervention.
|
|---|---|---|
|
Depression as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 57
12 Weeks
|
8.33 score on a scale
Standard Deviation 2.60
|
9.40 score on a scale
Standard Deviation 0.93
|
|
Depression as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 57
Baseline
|
10.5 score on a scale
Standard Deviation 3.32
|
11.40 score on a scale
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks. Baseline are pre intervention scores and 12 weeks are post intervention scores.The Psychological Flexibility in Pain Instrument will be used. The ability to act in alignment of goals, values and in acceptance while living with pain and distress.The Psychological Inflexibility in Pain Scale (PIPS) is a 12-item scale measuring avoidance of pain, and fusion with pain thoughts. Scores range from 7-84 with a higher score indicating increased psychological inflexibility in pain.
Outcome measures
| Measure |
Intervention Group
n=4 Participants
Individuals randomized to this group will start the intervention immediately and have outcomes measured at three time points.
|
Wait List Control Group
n=5 Participants
This group will be randomized to wait list control. They will serve as a control for the intervention at time points 1 and 2. However after a 2-3 month period they will receive the intervention.
|
|---|---|---|
|
Psychological Flexibility as Assessed by the Psychological Flexibility in Pain Instrument
Baseline
|
53.4 score on a scale
Standard Deviation 4.86
|
50.25 score on a scale
Standard Deviation 0.51
|
|
Psychological Flexibility as Assessed by the Psychological Flexibility in Pain Instrument
12 weeks
|
44.8 score on a scale
Standard Deviation 6.50
|
53.33 score on a scale
Standard Deviation 15.10
|
SECONDARY outcome
Timeframe: 12 weeksSelf-report if goals were achieved fully, partially or not at all. 23 goals were set.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineThe Charlson Comorbidity Index will be used to obtain a score for number of chronic conditions from 19 categories.The CCI consists of 19 selected conditions that are weighted and summed to an index on a 0-33 scale. Higher scores indicate more comorbidities.
Outcome measures
| Measure |
Intervention Group
n=4 Participants
Individuals randomized to this group will start the intervention immediately and have outcomes measured at three time points.
|
Wait List Control Group
n=5 Participants
This group will be randomized to wait list control. They will serve as a control for the intervention at time points 1 and 2. However after a 2-3 month period they will receive the intervention.
|
|---|---|---|
|
Comorbidities as Assessed by the Charlson Comorbidity Index (CCI)
|
3.22 score on a scale
Standard Deviation 1.92
|
3.22 score on a scale
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksSleep disturbance will be measured using the 4 item PROMIS sleep disturbance measure. This six item scale is used to measure sleep disturbances in the past 7 days and the range is 6 -30 with higher scores indicating more sleep disturbances.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 12 weeksThe Patients' Reaction Assessment has a 5-item subscale used to measure perceived ability to communicate with providers. The sub scale on perceived ability to communicate with providers can have scores ranging from 0-35 with higher scores indicating higher perceived ability to communicate.
Outcome measures
| Measure |
Intervention Group
n=4 Participants
Individuals randomized to this group will start the intervention immediately and have outcomes measured at three time points.
|
Wait List Control Group
n=5 Participants
This group will be randomized to wait list control. They will serve as a control for the intervention at time points 1 and 2. However after a 2-3 month period they will receive the intervention.
|
|---|---|---|
|
Communication With Health Care Providers- Patient Reaction Assessment
Baseline
|
5.61 score on a scale
Standard Deviation 0.51
|
3.96 score on a scale
Standard Deviation 0.25
|
|
Communication With Health Care Providers- Patient Reaction Assessment
12 weeks
|
5.36 score on a scale
Standard Deviation 0.35
|
4.61 score on a scale
Standard Deviation 0.35
|
Adverse Events
Wait List Control Group
Intervention Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place