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NCT07750912
Photobiomodulation Therapy for Pain Control in Post-Operative Total Knee Arthroplasty Patients: A Pilot Study
Conditions: Pain Management, TKA, Post Operative Analgesia, Low Level Laser Therapy
Sex: All
Ages: 30 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 15
Sponsor: Mohammad Burney, MD
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.
Eligibility Criteria
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 \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:
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Source: ClinicalTrials.gov (NCT07750912). StuddyBuddy aggregates publicly available trial information.