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

NCT07750912 | Not Yet Recruiting DMC

• 1 other identifier: 84391
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

TKA; Low Level Laser Therapy; Pain Management; Post Operative Analgesia

Keywords

Low Level Laser Therapy; Post operative pain control; TKA

Outcome Measures

Primary Outcomes (1)

• 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).

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

Study Arms (1)

PBMT Treatment

EXPERIMENTAL

first treatment (day of surgery in the PACU prior to discharge/transfer) and the treatments given in the first week, use 6 J/cm2, 6 W. For the second week of treatments, use 6 J/cm2, 15 W.

Device: LightForce XLI

Interventions

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.

Also known as: LTS-1000, LTS-1500, LTS-2500, LTS-4000

PBMT Treatment

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mohammad Burney, MD: lead
• Enovis: collaborator

Related Publications (7)

• Looney AL, Huntingford JL, Blaeser LL, Mann S. A randomized blind placebo-controlled trial investigating the effects of photobiomodulation therapy (PBMT) on canine elbow osteoarthritis. Can Vet J. 2018 Sep;59(9):959-966.

  PMID: 30197438 BACKGROUND

• Tumilty S, Mani R, Baxter GD. Photobiomodulation and eccentric exercise for Achilles tendinopathy: a randomized controlled trial. Lasers Med Sci. 2016 Jan;31(1):127-35. doi: 10.1007/s10103-015-1840-4. Epub 2015 Nov 26.

  PMID: 26610637 BACKGROUND

• Langella F, et al. Photobiomodulation after joint arthroplasty reduces pain and opioid use. Lasers in Medical Science. 2018.

  BACKGROUND

• Huang Z, et al. Photobiomodulation improves functional recovery after joint arthroplasty. Clinical Rehabilitation. 2022

  BACKGROUND

• Bjordal JM, et al. A systematic review of low-level laser therapy for musculoskeletal pain. BMJ. 2006;332(7547):912-916

  BACKGROUND

• Bahrami H, Moharrami A, Mirghaderi P, Mortazavi SMJ. Low-Level Laser and Light Therapy After Total Knee Arthroplasty Improves Postoperative Pain and Functional Outcomes: A Three-Arm Randomized Clinical Trial. Arthroplast Today. 2022 Dec 5;19:101066. doi: 10.1016/j.artd.2022.10.016. eCollection 2023 Feb.

  PMID: 36507283 BACKGROUND

• Ahmad MA, A Hamid MS, Yusof A. Effects of low-level and high-intensity laser therapy as adjunctive to rehabilitation exercise on pain, stiffness and function in knee osteoarthritis: a systematic review and meta-analysis. Physiotherapy. 2022 Mar;114:85-95. doi: 10.1016/j.physio.2021.03.011. Epub 2021 Mar 26.

  PMID: 34654554 BACKGROUND

Related Links

• Ahmad MA, Hamid MSA, Yusof A. Effects of low-level and high-intensity laser therapy as adjunctive to rehabilitation exercise on pain, stiffness and function in knee osteoarthritis: a systematic review and meta-analysis.
• Low-level laser and light therapy after total knee arthroplasty improves postoperative pain and functional outcomes: a three-arm randomized clinical trial. Arthroplasty Today
• Looney AL, Huntingford JL, Blaeser LL, Mann S. A randomized blind placebo-controlled trial investigating the effects of photobiomodulation therapy (PBMT) on canine elbow osteoarthritis.
• Tumilty S, Mani R, Baxter GD. Photobiomodulation and eccentric exercise for Achilles tendinopathy: a randomized controlled trial.

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammed U Burney, MD

  North Texas Medical Research Institute, PLLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Neumann, Certified Physician Assistant

CONTACT

972-503-9495; jsn.ntmri@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director

Model Details: To minimize bias when using historical controls, patients will be carefully matched on age, BMI, comorbidity profile, and surgical technique. Historical data will be abstracted using standardized chart review forms by blinded assessors, and sensitivity analyses will be conducted to confirm comparability. For our statistical plan, descriptive measures will initially be performed: categorical variables will be summarized by frequency counts along with associated percentages. Continuous variables will be summarized descriptively using number of subjects, mean, standard deviation, minimum, median, and maximum. Considering this a pilot trial we will not run a power analysis and no hypothesis testing will be performed. We estimate based on previous studies that a total intervention population of 15 patients compared to 15 patients matched by the historical patient population (total of 30 patients for this clinical trial) should be adequate to assess descriptive statistics.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: August 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: When the study is completed, access to study data will be provided through a secured database with the principal investigator.
• Access Criteria: After the study is completed, the de-identified, archived data will be transmitted to and stored for use by other researchers including those outside of the study. Permission to perform future analyses will be included in the informed consent. During the conduct of the study, an individual participant can choose to withdraw consent to have their de-identified data stored and utilized for future research. When the study is completed, access to study data will be provided through a secured database with the principal investigator.