Development and Validation of a Digital Pain-reduction Kit for Orthopedic Injuries
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 12/6/2018 |
| Start Date: | April 3, 2018 |
| End Date: | September 5, 2019 |
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 acute pain
due to orthopedic injuries. Outpatients will be randomized to receive either the pain
reduction kit or an active control. The kit will contain a virtual reality (VR) headset,
therapeutic VR visualization software, a low-cost wearable transcutaneous electrical nerve
stimulation (TENS) unit, and a remote activity monitor. Clinical staff will monitor progress
and provide scheduled coaching and outreach to patients in the intervention group. The
control group will receive a remote activity monitor alone; they will not receive VR, TENS,
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.
pain-reduction kit" as a non-pharmacological supplement to managing patients with acute pain
due to orthopedic injuries. Outpatients will be randomized to receive either the pain
reduction kit or an active control. The kit will contain a virtual reality (VR) headset,
therapeutic VR visualization software, a low-cost wearable transcutaneous electrical nerve
stimulation (TENS) unit, and a remote activity monitor. Clinical staff will monitor progress
and provide scheduled coaching and outreach to patients in the intervention group. The
control group will receive a remote activity monitor alone; they will not receive VR, TENS,
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.
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, aged 18-65
4. Actively employed
5. Seeking care for acute or semi-acute orthopedic injury occurring within the past 6
weeks prior to the visit
6. Experiencing pain greater than 3 out of 10 on a visual analog scale
7. English or Spanish speaking
Exclusion Criteria:
1. Unable to understand the goals of the study due to cognitive difficulty
2. Current or recent (less than 6 months) use of opioids
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)
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Brennan Spiegel, MD
Phone: 310-423-5434
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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