Opioid Sparing Potential of Light-Induced Analgesia

NCT ID: NCT03890419

Last Updated: 2021-10-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-17

Study Completion Date

2021-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control Group

Control Group participants will be exposed to full spectrum light during the study.

Group Type ACTIVE_COMPARATOR

Clear light

Intervention Type DEVICE

Full spectrum light exposure

Green light Group

Green light Group participants will be exposed to green light during the study.

Group Type EXPERIMENTAL

Green light

Intervention Type DEVICE

Green light exposure

Blue light Group

Blue light Group participants will be exposed to blue light during the study.

Group Type EXPERIMENTAL

Blue Light

Intervention Type DEVICE

Blue light exposure

Interventions

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Green light

Green light exposure

Intervention Type DEVICE

Clear light

Full spectrum light exposure

Intervention Type DEVICE

Blue Light

Blue light exposure

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Padma Gulur, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Health Systems

Durham, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Pro00102106

Identifier Type: -

Identifier Source: org_study_id