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

Not Applicable

Completed

Conditions: Pain, Acute
Pain, Chronic

Interventions: Device: Digital Pain Reduction Kit
Device: Active Control

Registration Number: NCT03187132

Lead Sponsor: Cedars-Sinai Medical Center

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 245

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital Pain Reduction Kit	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.
Active Control	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.

Primary Outcome Measures

Name	Time	Method
PROMIS - Physical Function Short Form 8b	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

Name	Time	Method
PROMIS - Pain Interference Short Form 8a	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.
Patient Satisfaction Questionnaire (PSQ) 18	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.
Binary, Self-reported Opioid Use	60 days	Investigators will examine opioid utilization using binary self-reported opioid use (e.g. 0=did not use opioidss;1=used opioids).
Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0)	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.