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Development and Validation of a Digital Pain-Reduction Kit for Musculoskeletal Injuries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03187132
Recruitment Status : Completed
First Posted : June 14, 2017
Results First Posted : August 5, 2021
Last Update Posted : August 5, 2021
Sponsor:
Collaborators:
Travelers
Samsung
AppliedVR Inc.
Bayer
Hollywog, LLC
Information provided by (Responsible Party):
Brennan Spiegel, Cedars-Sinai Medical Center

Study Description
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Brief Summary:
This study will test the effectiveness of an evidence-based, multi-modal, "digital pain-reduction kit" as a non-pharmacological supplement to managing patients with pain due to musculoskeletal injuries. Outpatients will be randomized to receive either the pain reduction kit or active control. The kit will contain a virtual reality (VR) headset, therapeutic VR visualization software, and a low-cost wearable transcutaneous electrical nerve stimulation (TENS) unit. Clinical staff will monitor progress and provide scheduled coaching and outreach to patients in the intervention group. The control group will receive the low-cost wearable transcutaneous electrical nerve stimulation (TENS) unit alone; they will not receive VR or remote coaching. Study devices will be delivered to the patient's home with instructions for use; patients will receive remote clinical and technical support. Patients will be followed for 60 days and monitored for functional status, pain levels, use of pain medications (including opioids), satisfaction with care, and time to returning to work.

Condition or disease Intervention/treatment Phase
Pain, Acute Pain, Chronic Device: Digital Pain Reduction Kit Device: Active Control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. PROMIS - Physical Function Short Form 8b [ Time Frame: 60 days ]
    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.


Secondary Outcome Measures :
  1. PROMIS - Pain Interference Short Form 8a [ Time Frame: 60 days ]
    PROMIS - 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.

  2. Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0) [ Time Frame: 60 days ]
    The 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.

  3. Patient Satisfaction Questionnaire (PSQ) 18 [ Time Frame: 60 days ]
    Patient 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.

  4. Binary, Self-reported Opioid Use [ Time Frame: 60 days ]
    Investigators will examine opioid utilization using binary self-reported opioid use (e.g. 0=did not use opioidss;1=used opioids).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, age 18 or older
  4. Seeking care for a musculoskeletal injury
  5. Experiencing pain greater than 3 out of 10 on a visual analog scale
  6. English or Spanish speaking
  7. Owns a compatible Android or iOS smartphone device (excluding tablets)

Exclusion Criteria:

  1. Unable to understand the goals of the study due to cognitive difficulty
  2. Use of a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device or high-frequency surgical equipment. (contraindication for TENS units)
  3. Pregnant (contraindication for TENS unit)
  4. Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware or software
  5. Hypersensitivity to flashing light or motion
  6. Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of other study hardware (e.g., open sores, wounds, or skin rash on face)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Travelers
Samsung
AppliedVR Inc.
Bayer
Hollywog, LLC
  Study Documents (Full-Text)

Documents provided by Brennan Spiegel, Cedars-Sinai Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] August 30, 2019
Informed Consent Form  [PDF] December 10, 2019

More Information
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Responsible Party: Brennan Spiegel, Director, Health Services Research, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03187132    
Other Study ID Numbers: Pro00049015
First Posted: June 14, 2017    Key Record Dates
Results First Posted: August 5, 2021
Last Update Posted: August 5, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Brennan Spiegel, Cedars-Sinai Medical Center:
virtual reality
transcutaneous electrical nerve stimulation
analgesia
Additional relevant MeSH terms:
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Acute Pain
Chronic Pain
Pain
Neurologic Manifestations