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NOT YET RECRUITING

NCT07750912

Photobiomodulation Therapy for Pain Control in Post-Operative Total Knee Arthroplasty Patients: A Pilot Study

Sponsor: Mohammad Burney, MD

View on ClinicalTrials.gov

Summary

A pilot study to assess the efficacy and feasibility of PBMT for pain control in patients undergoing a TKA and are discharged the same day from an ambulatory surgery center.

Key Details

Gender

All

Age Range

30 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-08

Completion Date

2028-07

Last Updated

2026-08-06

Healthy Volunteers

Conditions

Pain Management TKA Post Operative Analgesia Low Level Laser Therapy

Interventions

DEVICE

LightForce XLI

The LightForce XLi laser is FDA cleared to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle. The specific use of this device to decrease post-operative pain and improve function may be considered an off-label use. However, it is important to note that the off-label use of this device in the context of this study does not alter the fundamental safety or performance profile of the device in participants. This device (and other substantially equivalent devices) is commonly used in clinical practice in a rehabilitation setting to treat post-operative conditions and several studies have demonstrated safety and efficacy in post-operative use.

Inclusion Criteria: BMI less than or equal to 45 Currently set up for an elective primary total knee arthroplasty due to primary osteoarthritis Ability to provide informed consent to participate in the clinical trial Ability to understand and communicate in English Willingness to comply with all study procedures Exclusion Criteria: * poorly controlled comorbidities that would not allow surgical intervention such as poorly controlled diabetes (HbA1C \> 8.0) renal insufficiency (eGFR \<60) poorly controlled CV disease such as CHF that is NYHA class 3 and 4 * inability to receive the intervention including contraindications and/or known photosensitivity. * patients with history of total joint infection ever or any infection in the last 6 months * ASA score \>3 and Outpatient Arthroplasty Risk Assessment (OARA; medical risk stratification scoring system to help determine day surgery vs inpatient)1 score \> 80. * previous PBMT treatment within 3 months from the start of the study for the participant. * utilization of supplemental/holistic methods specifically for pain control (e.g. cannabidiol). This will be discontinued 30 days prior to TKA and will not be used during the duration of study participation. This will be evaluated by the Principal Investigator and study team prior to consent. * significant anti-coagulation usage (other than aspirin) 7 days prior to treatment * CV surgery within the last 6 months * significant neurologic compromise (acquired or congenital/genetic) of the lower extremity to be operated on or underlying neurologic condition that would confound results in the opinion of the investigator such as a previous brachial plexus injury after a motor vehicle accident or myasthenia gravis * regular opioid use prior to surgical intervention as defined as \>20 MME per day for 30 days prior to enrollment. * Intolerance/allergy to hydrocodone or codeine * significant physical deformity of the planned operative extremity that would confound the results in the opinion of the investigator(s) * Immunocompromised patients, that in the opinion of the investigators, would confound the patient's ability to heal such as rheumatoid arthritis patient taking immunosuppressants. * females who are pregnant or who are expecting to be pregnant for the duration of the study * any tattoos or other permanent markings located on the treatment area Male patients or female who are not pregnant and do not plan on future pregnancy during trial participation, between 30-65 years of age Exclusion Criteria: \-