Trial Outcomes & Findings for Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System (NCT NCT03299556)
NCT ID: NCT03299556
Last Updated: 2024-09-19
Results Overview
self reported 11-point pain scale. The numeric pain score (NPS) is self-reported by the patient on a scale of 0 to 10, with the following scale labels: no pain (0), mild pain (2), moderate pain (4), severe pain (6), very severe pain (8), and worst pain possible (10).
Recruitment status
COMPLETED
Target enrollment
420 participants
Primary outcome timeframe
Baseline, 12-month follow-up
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Wearable Health Tracker (WHT)
The WHT group includes only patients newly enrolled in the Geisinger Multidisciplinary Pain Program (MPP) who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up.
|
Historic Control (MPP)
Patients who were enrolled in the Multidisciplinary Pain Program (MPP) in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment.
|
Concurrent Control (MPM)
Patients being treated for chronic pain in the Geisinger Medical Pain Management (MPM) program over the same time period as the WHT group. These subjects do not receive the MPP educational program nor use WHT as part of their treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
113
|
146
|
161
|
|
Overall Study
COMPLETED
|
105
|
146
|
161
|
|
Overall Study
NOT COMPLETED
|
8
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System
Baseline characteristics by cohort
| Measure |
Wearable Health Tracker (WHT)
n=105 Participants
The WHT group includes only patients newly enrolled in the Geisinger Multidisciplinary Pain Program (MPP) who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up.
|
Historic Control (MPP)
n=146 Participants
Patients who were enrolled in the Multidisciplinary Pain Program (MPP) in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment.
|
Concurrent Control (MPM)
n=161 Participants
Patients being treated for chronic pain in the Geisinger Medical Pain Management (MPM) program over the same time period as the WHT group. These subjects do not receive the MPP educational program nor use WHT as part of their treatment.
|
Total
n=412 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.1 years
STANDARD_DEVIATION 12.8 • n=99 Participants
|
50.4 years
STANDARD_DEVIATION 11.8 • n=107 Participants
|
47.1 years
STANDARD_DEVIATION 12.5 • n=206 Participants
|
49.0 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
284 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
128 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
102 Participants
n=99 Participants
|
142 Participants
n=107 Participants
|
153 Participants
n=206 Participants
|
397 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
102 Participants
n=99 Participants
|
139 Participants
n=107 Participants
|
151 Participants
n=206 Participants
|
392 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12-month follow-upself reported 11-point pain scale. The numeric pain score (NPS) is self-reported by the patient on a scale of 0 to 10, with the following scale labels: no pain (0), mild pain (2), moderate pain (4), severe pain (6), very severe pain (8), and worst pain possible (10).
Outcome measures
| Measure |
Wearable Health Tracker (WHT)
n=79 Participants
The WHT group includes only patients newly enrolled in the Geisinger Multidisciplinary Pain Program (MPP) who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up.
|
Historic Control (MPP)
n=135 Participants
Patients who were enrolled in the Multidisciplinary Pain Program (MPP) in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment.
|
Concurrent Control (MPM)
n=139 Participants
Patients being treated for chronic pain in the Geisinger Medical Pain Management (MPM) program over the same time period as the WHT group. These subjects do not receive the MPP educational program nor use WHT as part of their treatment.
|
|---|---|---|---|
|
Numerical Pain Score (NPS)
Baseline
|
5.48 score on a scale
Standard Deviation 1.50
|
6.50 score on a scale
Standard Deviation 1.57
|
6.48 score on a scale
Standard Deviation 1.70
|
|
Numerical Pain Score (NPS)
12-month follow-up
|
5.22 score on a scale
Standard Deviation 1.53
|
6.10 score on a scale
Standard Deviation 1.36
|
6.15 score on a scale
Standard Deviation 1.54
|
PRIMARY outcome
Timeframe: Baseline, 12-month follow-upself reported measurement of depression. The scale ranges from 0 to 27, indicating the following levels of depression severity: none (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).
Outcome measures
| Measure |
Wearable Health Tracker (WHT)
n=33 Participants
The WHT group includes only patients newly enrolled in the Geisinger Multidisciplinary Pain Program (MPP) who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up.
|
Historic Control (MPP)
n=75 Participants
Patients who were enrolled in the Multidisciplinary Pain Program (MPP) in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment.
|
Concurrent Control (MPM)
n=31 Participants
Patients being treated for chronic pain in the Geisinger Medical Pain Management (MPM) program over the same time period as the WHT group. These subjects do not receive the MPP educational program nor use WHT as part of their treatment.
|
|---|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
Baseline
|
14.07 score on a scale
Standard Deviation 5.65
|
15.19 score on a scale
Standard Deviation 6.34
|
14.63 score on a scale
Standard Deviation 4.90
|
|
Patient Health Questionnaire (PHQ-9)
12-month follow-up
|
11.78 score on a scale
Standard Deviation 6.18
|
12.89 score on a scale
Standard Deviation 6.25
|
11.31 score on a scale
Standard Deviation 5.73
|
PRIMARY outcome
Timeframe: Baseline, 12-month follow-upcalculated from health records, average amount of daily pain medication \[as measured by the daily milligrams of morphine equivalents (MME)\].
Outcome measures
| Measure |
Wearable Health Tracker (WHT)
n=39 Participants
The WHT group includes only patients newly enrolled in the Geisinger Multidisciplinary Pain Program (MPP) who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up.
|
Historic Control (MPP)
n=74 Participants
Patients who were enrolled in the Multidisciplinary Pain Program (MPP) in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment.
|
Concurrent Control (MPM)
n=84 Participants
Patients being treated for chronic pain in the Geisinger Medical Pain Management (MPM) program over the same time period as the WHT group. These subjects do not receive the MPP educational program nor use WHT as part of their treatment.
|
|---|---|---|---|
|
Mean Daily Morphine Equivalents (MEQs)
Baseline
|
51.38 MME
Standard Deviation 44.84
|
56.83 MME
Standard Deviation 76.30
|
43.42 MME
Standard Deviation 68.62
|
|
Mean Daily Morphine Equivalents (MEQs)
12-month follow-up
|
38.36 MME
Standard Deviation 34.88
|
54.46 MME
Standard Deviation 66.51
|
43.69 MME
Standard Deviation 51.39
|
SECONDARY outcome
Timeframe: Baseline, 12-month follow-upPopulation: The numbers analyzed differ because two different measures were used - the ODI Back was administered only to patients with back pain, the ODI Neck was administered only to patients with neck pain.
self reported measure of functionality, related to back and neck pain. The ODI is a self-administered questionnaire assessing symptoms and severity of back or neck pain on a scale from 0 to 100. This measurement evaluates the loss of function in activities of daily living. Two ODI questionnaires were used in this study, one for neck pain and one for back pain. Interpretation of ODI scoring is as follows: minimal disability (0-20), moderate disability (21-40), severe disability (41-60), and crippled (61-80). Scores over 80 suggest the patient may be bedbound or exaggerating their symptoms and careful evaluation is recommended.
Outcome measures
| Measure |
Wearable Health Tracker (WHT)
n=54 Participants
The WHT group includes only patients newly enrolled in the Geisinger Multidisciplinary Pain Program (MPP) who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up.
|
Historic Control (MPP)
n=80 Participants
Patients who were enrolled in the Multidisciplinary Pain Program (MPP) in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment.
|
Concurrent Control (MPM)
n=36 Participants
Patients being treated for chronic pain in the Geisinger Medical Pain Management (MPM) program over the same time period as the WHT group. These subjects do not receive the MPP educational program nor use WHT as part of their treatment.
|
|---|---|---|---|
|
Oswestry Disability Index (ODI)
ODI (Neck) Baseline
|
50.07 score on a scale
Standard Deviation 14.51
|
59.23 score on a scale
Standard Deviation 13.96
|
53.10 score on a scale
Standard Deviation 13.70
|
|
Oswestry Disability Index (ODI)
ODI (Back) Baseline
|
47.67 score on a scale
Standard Deviation 13.54
|
55.05 score on a scale
Standard Deviation 12.43
|
51.20 score on a scale
Standard Deviation 11.78
|
|
Oswestry Disability Index (ODI)
ODI (Back) 12-month follow-up
|
45.46 score on a scale
Standard Deviation 14.38
|
53.99 score on a scale
Standard Deviation 12.99
|
46.28 score on a scale
Standard Deviation 16.74
|
|
Oswestry Disability Index (ODI)
ODI (Neck) 12-month follow-up
|
51.03 score on a scale
Standard Deviation 14.50
|
59.59 score on a scale
Standard Deviation 13.79
|
51.40 score on a scale
Standard Deviation 17.27
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsnumber of daily steps as measured by WHT application. Insufficient data collected for analysis of this outcome measure.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsquantity (hours) and quality as measured by WHT application. Insufficient data collected for analysis of this outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
Wearable Health Tracker (WHT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Historic Control (MPP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Concurrent Control (MPM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas Alfieri, PhD - Director, Medical Affairs Strategic Research
Purdue Pharma L.P.
Phone: (475) 299-6085
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place