An observational study in Chronic Pain, sponsored by Purdue Pharma LP. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Purdue Pharma LP (part of Knoa Pharma) · Observational
This is a proof of concept study to measure the effect of Wearable Health Technology (WHT), including the Apple Watch, iPhone, Pain App and Provider Dashboards on important clinical outcomes in patients treated for chronic pain. WHT will be tested in a group of chronic pain patients treated at a specialty pain clinic, the Geisinger Multidisciplinary Pain Program (MPP). Primary and secondary outcomes include pain, physical function, depression, pain medicine use, amount of sleep, activity levels, healthcare resource utilization and cost. The WHT will collect self-reported data on pain, pain management therapies, and medication utilization, and passively collected data on subject activity levels and sleep. Additional data will be collected on device utilization by patients and health care professionals.
This is a prospective, non-randomized, non-blinded trial with historic and concurrent controls to assess the effect of the addition of WHT on patient and health system outcomes. WHT used in this study are the Apple Watch and iPhone, a pain application (Pain App) designed specifically for this study to be used with the watch and phone, and physician and patient dashboards also designed for this study to provide subjects and health care providers data displays of information captured by the WHT.
The WHT will consist of:
Subjects will use the WHT 20 hours per day, every day for a period of 12 months.
Subjects will attend study visits at baseline and months 2, 4, 6, 8, 10 and 12.
Outcome data for control groups will be collected retrospectively from the electronic health record (EHR). Assessments will have occurred as part of their standard of care.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's enrollment of 420 is above the median of 120 across 753 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →Purdue Pharma LP is the lead sponsor of 58 studies on the registry; none are open to participants now.
First submitted before Purdue Pharma LP became part of Knoa Pharma.
Counted across the registry records on this site, refreshed daily.
Geisinger chronic pain patients, currently or previously enrolled in the MPP or currently receiving treatment in the MPM program.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The WHT group includes only patients newly enrolled in the Geisinger MPP program who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up.
Other: WHT
Patients who were enrolled in the MPP in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment.
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
Incorporating WHT into treatment for chronic pain. WHT includes patient and provider tracking of patient-reported pain, pain management, medication usage, functionality, depression, activity and sleep (measured by 3 axis actigraph); as well as prompts to subjects to engage in self-care, including non-pharmaceutical pain management therapies consistent with MPP training.
Numerical Pain Score (NPS)
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).
Time frame: Baseline, 12-month follow-up
Patient Health Questionnaire (PHQ-9)
self 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).
Time frame: Baseline, 12-month follow-up
Mean Daily Morphine Equivalents (MEQs)
calculated from health records, average amount of daily pain medication \[as measured by the daily milligrams of morphine equivalents (MME)\].
Time frame: Baseline, 12-month follow-up
Oswestry Disability Index (ODI)
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.
Time frame: Baseline, 12-month follow-up
Activity Levels (WHT Group Only)
number of daily steps as measured by WHT application. Insufficient data collected for analysis of this outcome measure.
Time frame: 12 months
Sleep (WHT Group Only)
quantity (hours) and quality as measured by WHT application. Insufficient data collected for analysis of this outcome measure.
Time frame: 12 months
| Milestone | Wearable Health Tracker (WHT) | Historic Control (MPP) | Concurrent Control (MPM) |
|---|---|---|---|
| Started | 113 | 146 | 161 |
| Completed | 105 | 146 | 161 |
| Not completed | 8 | 0 | 0 |
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).
| score on a scale | Wearable Health Tracker (WHT) | Historic Control (MPP) | Concurrent Control (MPM) |
|---|---|---|---|
| Baseline | 5.48 ± 1.50 | 6.50 ± 1.57 | 6.48 ± 1.70 |
| 12-month follow-up | 5.22 ± 1.53 | 6.10 ± 1.36 | 6.15 ± 1.54 |
self 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).
| score on a scale | Wearable Health Tracker (WHT) | Historic Control (MPP) | Concurrent Control (MPM) |
|---|---|---|---|
| Baseline | 14.07 ± 5.65 | 15.19 ± 6.34 | 14.63 ± 4.90 |
| 12-month follow-up | 11.78 ± 6.18 | 12.89 ± 6.25 | 11.31 ± 5.73 |
calculated from health records, average amount of daily pain medication \[as measured by the daily milligrams of morphine equivalents (MME)\].
| MME | Wearable Health Tracker (WHT) | Historic Control (MPP) | Concurrent Control (MPM) |
|---|---|---|---|
| Baseline | 51.38 ± 44.84 | 56.83 ± 76.30 | 43.42 ± 68.62 |
| 12-month follow-up | 38.36 ± 34.88 | 54.46 ± 66.51 | 43.69 ± 51.39 |
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.
| score on a scale | Wearable Health Tracker (WHT) | Historic Control (MPP) | Concurrent Control (MPM) |
|---|---|---|---|
| ODI (Back) Baseline | 47.67 ± 13.54 | 55.05 ± 12.43 | 51.20 ± 11.78 |
| ODI (Back) 12-month follow-up | 45.46 ± 14.38 | 53.99 ± 12.99 | 46.28 ± 16.74 |
| ODI (Neck) Baseline | 50.07 ± 14.51 | 59.23 ± 13.96 | 53.10 ± 13.70 |
| ODI (Neck) 12-month follow-up | 51.03 ± 14.50 | 59.59 ± 13.79 | 51.40 ± 17.27 |
number of daily steps as measured by WHT application. Insufficient data collected for analysis of this outcome measure.
Results for this outcome have not been posted.
quantity (hours) and quality as measured by WHT application. Insufficient data collected for analysis of this outcome measure.
Results for this outcome have not been posted.
Collected over Adverse events were collected up to 12 months for participants in the WHT group. Up to a 12-month retrospective review of AE data was performed for the patients in the MPP and MPM control groups.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Wearable Health Tracker (WHT) | 0/113 (0%) | 0/113 (0%) | 0/113 (0%) |
| Historic Control (MPP) | 0/146 (0%) | 0/146 (0%) | 0/146 (0%) |
| Concurrent Control (MPM) | 0/161 (0%) | 0/161 (0%) | 0/161 (0%) |
| Age, Continuous(years) | Wearable Health Tracker (WHT) | Historic Control (MPP) | Concurrent Control (MPM) | Total |
|---|---|---|---|---|
| Mean | 50.1 ± 12.8 | 50.4 ± 11.8 | 47.1 ± 12.5 | 49.0 ± 12.4 |
| Sex: Female, Male(Participants) | Wearable Health Tracker (WHT) | Historic Control (MPP) | Concurrent Control (MPM) | Total |
|---|---|---|---|---|
| Female | 81 | 93 | 110 | 284 |
| Male | 24 | 53 | 51 | 128 |
| Ethnicity (NIH/OMB)(Participants) | Wearable Health Tracker (WHT) | Historic Control (MPP) | Concurrent Control (MPM) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 3 | 4 | 8 | 15 |
| Not Hispanic or Latino | 102 | 142 | 153 | 397 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Wearable Health Tracker (WHT) | Historic Control (MPP) | Concurrent Control (MPM) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 1 |
| Asian | 0 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 5 | 9 | 17 |
| White | 102 | 139 | 151 | 392 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
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