Light Therapy for Postoperative Pain

Overseen By Mohab Ibrahim, PhD, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Must not be taking: Chronic opioids

Disqualifiers: Severe psychological conditions, colorblindness, others

Compensation: Varies

Number of Visits: 1

70 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on chronic opioids equal to or greater than 90 Morphine Milligram Equivalent (MME) per day, you would not be eligible to participate.

Is light therapy safe for humans?

The research articles provided do not contain specific safety data on light therapy, including Green or White LED light therapy, for postoperative pain or other conditions. ^{1 2 3 4 5}

How does light therapy differ from other treatments for postoperative pain?

Light therapy is unique because it uses light to reduce pain, which is different from traditional methods like drugs or physical techniques. This approach may offer a non-invasive option with potentially fewer side effects compared to standard pain medications. ^{6 7 8 9 10}

What is the purpose of this trial?

This is a prospective randomized clinical trial study to investigate two main aspects. The first aspect is to investigate the efficacy exposure to green light emitting diode (GLED) in reducing postoperative opioid medications requirements by 20% as the primary outcome amongst patients scheduled for elective total knee replacement surgery (knee arthroplasty). The second aspect is to reduce postoperative pain by 30%, improve preoperative anxiety by 30%, and improve the quality of sleep pre and postoperatively by 30%. Seventy participants scheduled for elective unilateral primary total knee arthroplasty (total knee replacement) will be recruited from the pain clinic or from the orthopedic surgery clinics at Banner-University Medical Center by the pain or orthopedic physicians who are key personnel of this study. Once a participant is identified, he/she will meet with one of the research team members to explain the nature of the clinical trial and undergo a standard of care medical history gathering and baseline physical examinations. If the participant meets all the inclusion and have no exclusion criteria, he/she will be presented with a written consent in English to explain all the risk and benefits of this clinical trial. Once a participant signs a consent, he or she will be randomized by the study statistician, in a 1:1 ratio to either a GLED group (treatment) or white light-emitting diode (WLED) group (control). The participant will be trained on how to use the light device by one of the research team members. All participants will be exposed to either GLED or WLED for 8 weeks prior to surgery and two additional weeks after surgery.

Research Team

Mohab Ibrahim, PhD, MD

Principal Investigator

University of Arizona

Eligibility Criteria

This trial is for adults over 18 who can read and write English, scheduled for elective knee replacement surgery. It's not suitable for those with colorblindness, severe mental health issues, chronic pain requiring high-dose opioids, or involved in legal cases related to injury compensation.

Inclusion Criteria

I am scheduled for my first knee replacement surgery.

Able to understand, read, and write English

Exclusion Criteria

I have been taking opioids equal to or more than 90 MME/day for chronic pain.

You have color vision deficiency.

My surgery cannot be delayed more than 8 weeks from joining the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-Surgery Treatment

Participants are exposed to either Green LED or White LED light for 8 weeks prior to surgery

8 weeks

Home-based exposure

Post-Surgery Treatment

Participants continue light exposure for 2 weeks after surgery, either at home or in the hospital

2 weeks

Home-based or hospital-based exposure

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Green LED light therapy
• White LED light therapy

Trial Overview The study tests if green LED light therapy (GLED) reduces the need for opioid painkillers by 20% after knee surgery. It also aims to cut post-surgery pain by 30%, lessen pre-surgery anxiety by the same amount, and improve sleep quality before and after the operation.

Participant Groups

Group I: Active Treatment Group (Green LED) Experimental Treatment 1 Intervention

Subjects will be exposed to a Green LED light for 8 weeks prior to surgery, during their hospital stay and for an additional 2 weeks after hospital discharge.

Group II: Control Group (White LED) Placebo Group 1 Intervention

Subjects will be exposed to a White LED light for 8 weeks prior to surgery, during their hospital stay and for an additional 2 weeks after hospital discharge.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Pain therapy to reduce perioperative complications. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

[The legal obligation for postoperative pain therapy]. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

[Implementation of standardized postoperative pain therapy for orthopaedic patients. Comparison between unsystematic and standardized pain therapy]. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The Effect of Nitroglycerine Infusion on Postoperative Pain in Lower Limb Surgery: A Clinical Double-Blind Study. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

[The Helsinki Declaration for Patient Safety in Anaesthesiology - Post operative care including pain management]. [2015]

6. Serbia pubmed.ncbi.nlm.nih.gov

[Postoperative pain as the fifth vital parameter]. [2009]

7. Germany pubmed.ncbi.nlm.nih.gov

[Progressive muscle relaxation in postoperative pain therapy]. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[Acute pain management after orthopaedic surgery]. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

[Post-operative pain management in orthopaedic surgery and traumatology]. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

[The effects of setting a standard in the acute pain therapy on a ward : Parameters for patient and provider satisfaction and cost structure (STANDAKU)]. [2022]