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

ConditionsPain Management TKA Post Operative Analgesia Low Level Laser Therapy

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age30-65

SponsorMohammad Burney, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

LightForce XLI
Device
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.

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: PBMT TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Reduction in pain in patients discharged same day from an ASC after a TKA as measured by the PROMIS NRS

In this pilot trial, the primary objective is to assess the efficacy of PBMT as an adjunct in a post-operative pain regiment utilized after a total knee arthroplasty in patients that are discharged the same day compared to matched historical control patients who also received a TKA and were discharged the same day as measured by the PROMIS NRS. Scale of 0 (no pain) - 10 (worst pain imaginable).

Time frame

Each participant will complete all visits by 90 days from the date of surgery.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mohammad Burney, MD

Lead sponsor

North Texas Medical Research Institute, PLLC

Sponsor institution

Enovis

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: