The Effectiveness of High-intensity Laser Therapy on Post-surgical Rehabilitation After Total Kne… (NCT07568262) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effectiveness of High-intensity Laser Therapy on Post-surgical Rehabilitation After Total Knee Arthroplasty
Italy46 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Psychiatric disorders
* Cognitive impairments
* Previous major trauma or surgery involving the affected knee
* Rheumatic diseases or fibromyalgia
* Vascular diseases
* Neoplastic diseases
* Infectious diseases
* Neurological disorders
* Hemophilia or bleeding disorders
* Current anticoagulant therapy
* Presence of a pacemaker
* History of epileptic seizures
* Known hypersensitivity or contraindication to laser therapy
* Suspected conditions in which tissue heating is contraindicated
* Use of photosensitizing medications or known photosensitivity
* Skin lesions or abrasions at the treatment site
* Tattoos in the treatment area
* Intra-articular steroid injections in the target knee within the previous 2-3 weeks
* Recent significant trauma or injury
* Use of anti-inflammatory or analgesic medications or other pain-relieving treatments (if not controlled or standardized)
* Pregnancy or breastfeeding
* Positive status for human immunodeficiency virus
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.