Trial Outcomes & Findings for Development and Validation of a Digital Pain-Reduction Kit for Musculoskeletal Injuries (NCT NCT03187132)
NCT ID: NCT03187132
Last Updated: 2021-08-05
Results Overview
PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. A single Physical Function capability score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Physical Function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
COMPLETED
NA
245 participants
60 days
2021-08-05
Participant Flow
Initial Deployment: Inpatient trauma only, in-person recruitment of CSMC trauma patients with no opioid prescription. 3/28/2018 - 10/31/2018 Inpatient trauma + Pain Clinic. In-person recruitment of cLBP patients without opioid prescription at single CSMC pain specialty clinic. 11/1/2018 - 12/31/2018 Revised: Inpatient Trauma + Pain Clinic. Patients with opioid prescription allowed to participate. 1/1/2019 - 4/23/2019 Revised: Pain Clinic only, recruitment fully remote. 4/23/2019 - End
Of 1156 patients assessed for eligibility, 245 met criteria and were randomized.
Participant milestones
| Measure |
Digital Pain Reduction Kit
Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians.
Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain.
|
Active Control
Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit.
Active Control: An active control TENS unit used to reduce acute localized pain.
|
|---|---|---|
|
Inpatient Trauma Only
STARTED
|
12
|
12
|
|
Inpatient Trauma Only
COMPLETED
|
8
|
0
|
|
Inpatient Trauma Only
NOT COMPLETED
|
4
|
12
|
|
Inpatient Trauma+Pain Clinic, no Opioid
STARTED
|
4
|
5
|
|
Inpatient Trauma+Pain Clinic, no Opioid
COMPLETED
|
3
|
0
|
|
Inpatient Trauma+Pain Clinic, no Opioid
NOT COMPLETED
|
1
|
5
|
|
Inpatient Trauma+Pain Clinic
STARTED
|
11
|
7
|
|
Inpatient Trauma+Pain Clinic
COMPLETED
|
8
|
0
|
|
Inpatient Trauma+Pain Clinic
NOT COMPLETED
|
3
|
7
|
|
Pain Clinic Only, Fully Remote
STARTED
|
76
|
118
|
|
Pain Clinic Only, Fully Remote
COMPLETED
|
43
|
64
|
|
Pain Clinic Only, Fully Remote
NOT COMPLETED
|
33
|
54
|
Reasons for withdrawal
| Measure |
Digital Pain Reduction Kit
Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians.
Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain.
|
Active Control
Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit.
Active Control: An active control TENS unit used to reduce acute localized pain.
|
|---|---|---|
|
Inpatient Trauma Only
Lost to Follow-up
|
3
|
12
|
|
Inpatient Trauma Only
socioeconomic burden
|
1
|
0
|
|
Inpatient Trauma+Pain Clinic, no Opioid
Lost to Follow-up
|
0
|
5
|
|
Inpatient Trauma+Pain Clinic, no Opioid
Disease burden
|
1
|
0
|
|
Inpatient Trauma+Pain Clinic
Lost to Follow-up
|
2
|
5
|
|
Inpatient Trauma+Pain Clinic
Disease burden
|
1
|
0
|
|
Inpatient Trauma+Pain Clinic
Unhappy with allocation
|
0
|
2
|
|
Pain Clinic Only, Fully Remote
Lost to Follow-up
|
27
|
47
|
|
Pain Clinic Only, Fully Remote
Disease burden
|
6
|
5
|
|
Pain Clinic Only, Fully Remote
Language barrier
|
0
|
1
|
|
Pain Clinic Only, Fully Remote
EMR
|
0
|
1
|
Baseline Characteristics
Development and Validation of a Digital Pain-Reduction Kit for Musculoskeletal Injuries
Baseline characteristics by cohort
| Measure |
Digital Pain Reduction Kit
n=67 Participants
Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians.
Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain.
|
Active Control
n=69 Participants
Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit.
Active Control: An active control TENS unit used to reduce acute localized pain.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
64 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
PROMIS - Physical Function Short Form 8b
|
34.5 units on a scale
STANDARD_DEVIATION 6.5 • n=5 Participants
|
38.6 units on a scale
STANDARD_DEVIATION 6.3 • n=7 Participants
|
36.60 units on a scale
STANDARD_DEVIATION 6.69 • n=5 Participants
|
PRIMARY outcome
Timeframe: 60 daysPopulation: Participants with a week 1 response.
PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. A single Physical Function capability score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Physical Function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
Outcome measures
| Measure |
Digital Pain Reduction Kit
n=67 Participants
Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians.
Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain.
|
Active Control
n=69 Participants
Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit.
Active Control: An active control TENS unit used to reduce acute localized pain.
|
|---|---|---|
|
PROMIS - Physical Function Short Form 8b
|
34.5 units on a scale
Standard Deviation 6.5
|
38.6 units on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: 60 daysPROMIS - Pain Interference instruments assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. A single Pain interference score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Pain Interference, a T-score of 60 is one SD higher pain than average. By comparison, a Pain Interference T-score of 40 is one SD lower pain than average.
Outcome measures
| Measure |
Digital Pain Reduction Kit
n=64 Participants
Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians.
Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain.
|
Active Control
n=69 Participants
Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit.
Active Control: An active control TENS unit used to reduce acute localized pain.
|
|---|---|---|
|
PROMIS - Pain Interference Short Form 8a
|
64.8 score on a scale
Standard Deviation 7.4
|
63.2 score on a scale
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: 60 daysThe WPAI:LBP was created as a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to Lower Back Pain. The WPAI:LBP productivity loss subscale consists of a single item ("During the past seven days, how much did your pain affect your productivity while you were working?") with a 0-10 response scale where 0 indicates pain had no effect, and 10 indicates pain completely prevented work. The presenteeism sub-scale consists of a comparison two items, yielding percent of hours missed due to pain. Finally, the activity impairment subscale consists of one item("During the past seven days, how much did your pain affect your ability to do your regular daily activities, other than work at a job?") with a 0-10 response scale where 0 indicated pain had no effect, and 10 indicated pain completely prevented daily activities.
Outcome measures
| Measure |
Digital Pain Reduction Kit
n=39 Participants
Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians.
Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain.
|
Active Control
n=46 Participants
Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit.
Active Control: An active control TENS unit used to reduce acute localized pain.
|
|---|---|---|
|
Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0)
WPAI: Presenteism (%hours)
|
26.9 score on a scale
Standard Deviation 22.6
|
26.4 score on a scale
Standard Deviation 16.8
|
|
Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0)
WPAI: Productivity
|
7.3 score on a scale
Standard Deviation 2.3
|
7.1 score on a scale
Standard Deviation 1.9
|
|
Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0)
WPAI: Activity Impairment
|
7.1 score on a scale
Standard Deviation 2.8
|
7.0 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 60 daysPatient Satisfaction Questionnaire (PSQ) 18 which includes questions in 3 relevant domains: general satisfaction, communication, and accessibility of care. All subscales are scored so that high scores reflect satisfaction with medical care. Each domain averages responses to items with a range of 1-5, with 5 indicating the highest satisfaction.
Outcome measures
| Measure |
Digital Pain Reduction Kit
n=50 Participants
Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians.
Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain.
|
Active Control
n=65 Participants
Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit.
Active Control: An active control TENS unit used to reduce acute localized pain.
|
|---|---|---|
|
Patient Satisfaction Questionnaire (PSQ) 18
PSQ General Satisfaction
|
3.25 score on a scale
Standard Deviation .15
|
3.49 score on a scale
Standard Deviation .12
|
|
Patient Satisfaction Questionnaire (PSQ) 18
PSQ Communication
|
3.55 score on a scale
Standard Deviation 1.02
|
3.84 score on a scale
Standard Deviation .80
|
|
Patient Satisfaction Questionnaire (PSQ) 18
PSQ Access
|
3.2 score on a scale
Standard Deviation .85
|
3.52 score on a scale
Standard Deviation .10
|
SECONDARY outcome
Timeframe: 60 daysPopulation: Includes all respondents to both primary outcome week 1 and opioid surveys.
Investigators will examine opioid utilization using binary self-reported opioid use (e.g. 0=did not use opioidss;1=used opioids).
Outcome measures
| Measure |
Digital Pain Reduction Kit
n=53 Participants
Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians.
Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain.
|
Active Control
n=66 Participants
Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit.
Active Control: An active control TENS unit used to reduce acute localized pain.
|
|---|---|---|
|
Binary, Self-reported Opioid Use
|
11 Participants
|
15 Participants
|
Adverse Events
Digital Pain Reduction Kit
Active Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Digital Pain Reduction Kit
n=103 participants at risk
Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians.
Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain.
|
Active Control
n=142 participants at risk
Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit.
Active Control: An active control TENS unit used to reduce acute localized pain.
|
|---|---|---|
|
Product Issues
Pain when using device
|
0.00%
0/103 • 10 weeks
|
0.70%
1/142 • Number of events 1 • 10 weeks
|
|
Product Issues
Random discharge & subsequent cramping
|
0.00%
0/103 • 10 weeks
|
0.70%
1/142 • Number of events 1 • 10 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place