Photobiomodulation Therapy for Pain Control in Post-Operative Total Knee Arthroplasty Patients: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- Reduction in pain in patients discharged same day from an ASC after a TKA as measured by the PROMIS NRS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 >
- •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:
研究组 & 干预措施
PBMT Treatment
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.
干预措施: LightForce XLI (Device)
结局指标
主要结局
Reduction in pain in patients discharged same day from an ASC after a TKA as measured by the PROMIS NRS
时间窗: Each participant will complete all visits by 90 days from the date of surgery.
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).
次要结局
未报告次要终点
研究者
Mohammad Burney, MD
Medical Director
North Texas Medical Research Institute, PLLC