Development and Validation of a Digital Pain-Reduction Kit for Musculoskeletal Injuries
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|ClinicalTrials.gov Identifier: NCT03187132|
Recruitment Status : Completed
First Posted : June 14, 2017
Last Update Posted : July 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pain, Acute Pain, Chronic||Device: Digital Pain Reduction Kit Device: Active Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||245 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development and Validation of a Digital Pain-Reduction Kit for Musculoskeletal Injuries|
|Actual Study Start Date :||April 3, 2018|
|Actual Primary Completion Date :||May 20, 2020|
|Actual Study Completion Date :||May 20, 2020|
Experimental: 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.
Device: 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 Comparator: 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.
Device: Active Control
An active control TENS unit used to reduce acute localized pain.
- Physical Function [ Time Frame: 60 days ]Participants will complete weekly surveys (PROMIS® PF short-form) of self-reported physical function.
- Pain Interference [ Time Frame: 60 days ]Participants will complete weekly surveys (PROMIS® Pain Interference) of self-reported pain interference.
- Work Productivity [ Time Frame: 60 days ]Participants will complete the WPAI:LB assessing work absenteeism and presenteeism.
- Satisfaction with Pain Treatment and Healthcare [ Time Frame: 60 days ]Investigators will assess satisfaction with healthcare in participants using a validated instruments.
- Opioid Use [ Time Frame: 60 days ]Investigators will examine pre and post prescription history for opioids using 90 Morphine Milligram Equivalents.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187132
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|