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

NCT ID: NCT03187132

Last Updated: 2021-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-03
• Study Completion Date: 2020-05-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Digital Pain Reduction Kit

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Active Control

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Active Control

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

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Travelers

INDUSTRY

Sponsor Role: collaborator

Samsung

INDUSTRY

Sponsor Role: collaborator

AppliedVR Inc.

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: collaborator

Hollywog

INDUSTRY

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Brennan Spiegel

Director, Health Services Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00049015

Identifier Type: -

Identifier Source: org_study_id