NCT03187132

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

Completed NA Results posted Last updated 5 August 2021

What this trial tests

NA trial testing Digital Pain Reduction Kit in Pain, Acute in 245 participants. Completed in 20 May 2020.

Timeline

3 April 2018

Primary endpoint
20 May 2020

20 May 2020

Quick facts

Lead sponsor	Cedars-Sinai Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	245
Start date	3 April 2018
Primary completion	20 May 2020
Estimated completion	20 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Digital Pain Reduction Kit
• Active Control — full drug profile →

Conditions studied

• Pain, Acute — all drugs for Pain, Acute →
• Pain, Chronic — all drugs for Pain, Chronic →

Sponsor

Cedars-Sinai Medical Center

Who can join

18 and older, any sex, with Pain, Acute or Pain, Chronic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

PROMIS - Physical Function Short Form 8b Primary · 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.

Group	Value	95% CI
Digital Pain Reduction Kit	34.5	± 6.5
Active Control	38.6	± 6.3

PROMIS - Pain Interference Short Form 8a Secondary · 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.

Group	Value	95% CI
Digital Pain Reduction Kit	64.8	± 7.4
Active Control	63.2	± 7.2

Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0) Secondary · 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 impairme

WPAI: Presenteism (%hours)

Group	Value	95% CI
Digital Pain Reduction Kit	26.9	± 22.6
Active Control	26.4	± 16.8

WPAI: Productivity

Group	Value	95% CI
Digital Pain Reduction Kit	7.3	± 2.3
Active Control	7.1	± 1.9

WPAI: Activity Impairment

Group	Value	95% CI
Digital Pain Reduction Kit	7.1	± 2.8
Active Control	7.0	± 2.5

Patient Satisfaction Questionnaire (PSQ) 18 Secondary · 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.

PSQ General Satisfaction

Group	Value	95% CI
Digital Pain Reduction Kit	3.25	± .15
Active Control	3.49	± .12

PSQ Communication

Group	Value	95% CI
Digital Pain Reduction Kit	3.55	± 1.02
Active Control	3.84	± .80

PSQ Access

Group	Value	95% CI
Digital Pain Reduction Kit	3.2	± .85
Active Control	3.52	± .10

Binary, Self-reported Opioid Use Secondary · 60 days

Investigators will examine opioid utilization using binary self-reported opioid use (e.g. 0=did not use opioidss;1=used opioids).

Group	Value	95% CI
Digital Pain Reduction Kit	11
Active Control	15

Adverse events — posted to ClinicalTrials.gov

Time frame: 10 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Digital Pain Reduction Kit

Serious: 0/103 (0%)

Deaths: 0/103

Active Control

Serious: 0/142 (0%)

Deaths: 0/142

Other adverse events (2 terms — click to expand)

Reaction	System	Digital Pain Reduction Kit	Active Control
Pain when using device	Product Issues	—	—
Random discharge & subsequent cramping	Product Issues	—	—

Data from ClinicalTrials.gov NCT03187132 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.