N/A
N=94
Opioid Sparing Potential of Light-Induced Analgesia
Pain
Bottom Line
View on ClinicalTrials.gov: NCT03890419 ↗Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Change in Pain Level — 1.15; -0.04; 1.07 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Green light (Device); Clear light (Device); Blue Light (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Level |
1.15; -0.04; 1.07 | — |
| PRIMARY Change in Opioid Dose Used for Pain |
37.36; 37.38; 56.20 | — |
Summary
This is a pilot trial testing the potential opioid-sparing analgesic effect of a novel non-pharmacological treatment using visualized light spectrums. Preclinical findings have shown such treatments to alter pain perception.
Eligibility Criteria
Inclusion Criteria
- Scheduled for thoracic surgery for which post-operative opioid PCA is anticipated (Acute Pain group) OR currently treated with opioid therapy for fibromyalgia (Chronic Pain group)
- 18 years of age and older
- Able to wear study eyeglasses for at least 4 hours per day
- Agree to participate and provide written informed consent and HIPAA authorization
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT03890419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.