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

Обзор

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.

Подробное описание

Total knee arthroplasty (TKA) is one of the most frequently performed orthopedic surgeries in the United States, with the volume of procedures steadily rising due to an aging population and the growing prevalence of osteoarthritis. Given the shift toward outpatient settings and same-day discharges, effective postoperative pain management has become increasingly crucial for successful recovery in TKA patients.

Traditional pain management strategies in TKA, including nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids, often begin perioperatively as part of a multimodal approach. Although NSAIDs and opioids can effectively reduce pain, they carry significant risks. Opioids are associated with dependency, respiratory depression, and other adverse effects, while NSAIDs pose risks of gastrointestinal bleeding, renal impairment, and cardiovascular complications. This creates a pressing need for alternative, non-pharmacological methods of pain management, particularly for patients discharged on the same day who must manage pain effectively without excessive reliance on opioids.

PBMT has emerged as a promising adjunct in managing postoperative pain. PBMT involves applying light in the red to near-infrared spectrum, which penetrates tissue, stimulating cellular processes that can reduce inflammation and promote healing. Mechanistically, PBMT enhances mitochondrial activity, increasing adenosine triphosphate (ATP) production, modulating reactive oxygen species (ROS), and upregulating transcription factors related to anti-inflammatory effects. This non-invasive therapy has shown efficacy in reducing pain and inflammation in various musculoskeletal and postoperative contexts.

Although PBMT has been widely applied in managing chronic pain and inflammation, its use in immediate postoperative care for patients undergoing same-day discharge TKA has not been evaluated. Given its potential to reduce pain without the risks associated with pharmacologic therapies, PBMT may provide a valuable addition to pain management protocols in TKA.

The primary aim of this clinical trial is to evaluate the feasibility and effectiveness of PBMT in managing postoperative pain for patients undergoing TKA with same-day discharge. Pain will be assessed through PROMIS pain measures, opioid usage in morphine milligram equivalents (MME), and additional parameters related to recovery and function, including the Knee Osteoarthritis Outcome Score (KOOS) and range of motion (ROM). The trial will explore whether PBMT can decrease reliance on opioids, improve functional outcomes, and offer a safer, more sustainable pain management strategy for TKA patients in outpatient settings.

Вмешательства

• Устройство 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

Первичные конечные точки

• Reduction in pain in patients discharged same day from an ASC after a TKA as measured by the PROMIS NRS [Срок оценки: Each participant will complete all visits by 90 days from the date of surgery.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии исключения

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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
• 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
• Langella F, et al. Photobiomodulation after joint arthroplasty reduces pain and opioid use. Lasers in Medical Science. 2018.
• Huang Z, et al. Photobiomodulation improves functional recovery after joint arthroplasty. Clinical Rehabilitation. 2022
• Bjordal JM, et al. A systematic review of low-level laser therapy for musculoskeletal pain. BMJ. 2006;332(7547):912-916
• 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
• 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

Идентификаторы

NCT: NCT07750912 · 84391

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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