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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorIstituto Ortopedico Rizzoli

About this trial

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.

Eligibility criteria

Qualifiers

Patients undergoing primary unilateral total knee arthroplasty for primary knee osteoarthritis

Age between 50 and 80 years

Pain intensity greater than 30/100 on the Visual Analog Scale (VAS)

Ability and willingness to provide written informed consent

Disqualifiers

Psychiatric disorders

Cognitive impairments

Previous major trauma or surgery involving the affected knee

Rheumatic diseases or fibromyalgia

Trial design

Treatments tested in this trial

  • High level laser therapy
  • Sham laser therapy

Treatment groups

46 Participants
are divided into 2 treatment groups

Sponsors and collaborators