Back to resultsDevelopment and Validation of a Digital Pain-Reduction Kit for Musculoskeletal Injuries
Primary Purpose
Pain, Acute, Pain, Chronic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital Pain Reduction Kit
Active Control
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Acute focused on measuring virtual reality, transcutaneous electrical nerve stimulation, analgesia
Eligibility Criteria
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, age 18 or older
- Seeking care for a musculoskeletal injury
- Experiencing pain greater than 3 out of 10 on a visual analog scale
- English or Spanish speaking
- Owns a compatible Android or iOS smartphone device (excluding tablets)
Exclusion Criteria:
- Unable to understand the goals of the study due to cognitive difficulty
- Use of a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device or high-frequency surgical equipment. (contraindication for TENS units)
- Pregnant (contraindication for TENS unit)
- Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware or software
- Hypersensitivity to flashing light or motion
- 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)
Sites / Locations
- Cedars-Sinai Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Digital Pain Reduction Kit
Active Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
PROMIS - Physical Function Short Form 8b
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
PROMIS - Pain Interference Short Form 8a
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.
Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0)
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.
Patient Satisfaction Questionnaire (PSQ) 18
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.
Binary, Self-reported Opioid Use
Investigators will examine opioid utilization using binary self-reported opioid use (e.g. 0=did not use opioidss;1=used opioids).
Full Information
NCT ID
NCT03187132
First Posted
June 12, 2017
Last Updated
July 13, 2021
Sponsor
Cedars-Sinai Medical Center
Collaborators
Travelers, Samsung, AppliedVR Inc., Bayer, Hollywog, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03187132
Brief Title
Development and Validation of a Digital Pain-Reduction Kit for Musculoskeletal Injuries
Official Title
Development and Validation of a Digital Pain-Reduction Kit for Musculoskeletal Injuries
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 3, 2018 (Actual)
Primary Completion Date
May 20, 2020 (Actual)
Study Completion Date
May 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
Collaborators
Travelers, Samsung, AppliedVR Inc., Bayer, Hollywog, LLC
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Pain, Chronic
Keywords
virtual reality, transcutaneous electrical nerve stimulation, analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
245 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Digital Pain Reduction Kit
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Digital Pain Reduction Kit
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Active Control
Intervention Description
An active control TENS unit used to reduce acute localized pain.
Primary Outcome Measure Information:
Title
PROMIS - Physical Function Short Form 8b
Description
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.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
PROMIS - Pain Interference Short Form 8a
Description
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.
Time Frame
60 days
Title
Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0)
Description
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.
Time Frame
60 days
Title
Patient Satisfaction Questionnaire (PSQ) 18
Description
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.
Time Frame
60 days
Title
Binary, Self-reported Opioid Use
Description
Investigators will examine opioid utilization using binary self-reported opioid use (e.g. 0=did not use opioidss;1=used opioids).
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, age 18 or older
Seeking care for a musculoskeletal injury
Experiencing pain greater than 3 out of 10 on a visual analog scale
English or Spanish speaking
Owns a compatible Android or iOS smartphone device (excluding tablets)
Exclusion Criteria:
Unable to understand the goals of the study due to cognitive difficulty
Use of a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device or high-frequency surgical equipment. (contraindication for TENS units)
Pregnant (contraindication for TENS unit)
Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware or software
Hypersensitivity to flashing light or motion
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)
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
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Development and Validation of a Digital Pain-Reduction Kit for Musculoskeletal Injuries
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