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

NCT03187132 | Completed Results FDA Device

• 1 other identifier: Pro00049015
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Pain, Chronic

Keywords

virtual reality; transcutaneous electrical nerve stimulation; analgesia

Outcome Measures

Primary Outcomes (1)

• 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.

  60 days

Secondary Outcomes (4)

• PROMIS - Pain Interference Short Form 8a

  60 days

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

  60 days

• Patient Satisfaction Questionnaire (PSQ) 18

  60 days

• Binary, Self-reported Opioid Use

  60 days

Study Arms (2)

Digital Pain Reduction Kit

EXPERIMENTAL

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

Active Control

ACTIVE COMPARATOR

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

Interventions

Digital Pain Reduction Kit DEVICE

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.

Digital Pain Reduction Kit

Active Control DEVICE

An active control TENS unit used to reduce acute localized pain.

Active Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Travelers: collaborator
• Samsung: collaborator
• AppliedVR Inc.: collaborator
• Bayer: collaborator
• Hollywog: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Acute Pain; Chronic Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: R. Brennan Spiegel
• Organization: CedarsSinaiMC

Brennan.Spiegel@cshs.org

310-423-6784

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Health Services Research

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 14, 2017
• Study Start: April 3, 2018
• Primary Completion: May 20, 2020
• Study Completion: May 20, 2020
• Last Updated: August 5, 2021
• Results First Posted: August 5, 2021

Record last verified: 2021-07

Locations

US (1)