Opioid Sparing Potential of Light-Induced Analgesia

NCT03890419 | Completed Results

• 1 other identifier: Pro00102106
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

Acute Pain; Chronic Pain; Opioid Use; Pain

Outcome Measures

Primary Outcomes (2)

• Change in Pain Level

  Pain level assessed using the Numeric Rating Scale. In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'. Primary assessment is day 1 compared to end of study assessment (week 2 in chronic pain and 48 hours in acute pain). The end of study values were averaged with standard deviation for all patients at their end of study assessment.

  Baseline to end of study

• Change in Opioid Dose Used for Pain

  Change in amount of opioid medication used for pain relief measured in oral morphine equivalents. Primary assessment is day 1 compared to end of study assessment (week 2 in chronic pain and 48 hours in acute pain). The end of study values were averaged with standard deviation for all patients at their end of study assessment.

  Baseline to end of study

Study Arms (3)

Control Group

ACTIVE COMPARATOR

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

Device: Clear light

Green light Group

EXPERIMENTAL

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

Device: Green light

Blue light Group

EXPERIMENTAL

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

Device: Blue Light

Interventions

Green light DEVICE

Green light exposure

Green light Group

Clear light DEVICE

Full spectrum light exposure

Control Group

Blue Light DEVICE

Blue light exposure

Blue light Group

Eligibility Criteria

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

You may qualify if:

• 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)
• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health Systems

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Pain; Acute Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Padma Gulur
• Organization: Duke University

padma.gulur@duke.edu

919-681-4660

Study Officials

• Padma Gulur, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 26, 2019
• Study Start: June 17, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: October 13, 2021
• Results First Posted: October 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)