Clinical Trial

The Effectiveness of High-intensity Laser Therapy on Post-surgical Rehabilitation After Total Knee Arthroplasty

Not Yet Recruiting
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Summary
This randomized controlled trial aims to evaluate the effectiveness of high-intensity laser therapy (HILT) as an adjunct to conventional rehabilitation in patients undergoing total knee arthroplasty (TKA). Persistent pain and functional limitations are common after TKA despite standard rehabilitation, highlighting the need for adjunctive therapies to optimize postoperative recovery. High-intensity laser therapy has been proposed as a non-invasive intervention with potential analgesic and anti-inflammatory effects; however, its effectiveness in this population remains unclear. Participants will be randomly allocated to one of two groups: an experimental group receiving HILT in addition to conventional physiotherapy and a control group receiving sham laser therapy combined with the same rehabilitation program. Both groups will undergo standardized rehabilitation sessions lasting 60 minutes, including 15 minutes of active or sham laser therapy and 45 minutes of conventional physiotherapy. The primary outcome is postoperative pain. Secondary outcomes include joint swelling, range of motion, muscle strength, physical function, and quality of life. Assessments will be conducted at baseline (preoperative), at 1 month after surgery (prior to the start of rehabilitation), during the rehabilitation program (after the fourth, seventh, and tenth physiotherapy sessions), and at 4 months postoperatively (follow-up). A total of 46 participants (23 per group) will be enrolled in the study.
Trial Details
NCT Number NCT07568262
Lead Sponsor Istituto Ortopedico Rizzoli
Conditions Arthroplasty Complications, Pain, Postoperative
Enrollment 46 participants
Start Date 2026-09
Primary Completion 2027-09 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-05-05