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

NCT07568262 | Not Yet Recruiting

• 1 other identifier: LASER_KNEE
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthroplasty Complications; Pain, Postoperative

Keywords

Total knee arthroplasty; High-level laser therapy; Laser therapy; Post-operative pain; Rehabilitation; Physical therapy

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  The VAS consists of a 100-mm horizontal line anchored by two descriptors: "no pain" (0 mm) and "worst imaginable pain" (100 mm). Participants will be asked to mark a point on the line corresponding to their perceived level of pain. The score will be determined by measuring the distance in millimeters from the left end of the line to the patient's mark, with higher scores indicating greater pain intensity.

  after 3 weeks

Secondary Outcomes (5)

• Visual Analogue Scale

  Baseline, after 1 week, after 2 weeks, after 4 months follow-up

• Range of Motion

  Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up

• Swelling

  Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up

• Lower limb muscle strength

  Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up

• Western Ontario and McMaster Universities Osteoarthritis Index

  Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up

Study Arms (2)

High level laser therapy group

EXPERIMENTAL

High-intensity laser therapy (HILT) will be delivered using the HIRO TT device (ASA S.r.l.), which employs a patented pulsed laser system (FDA-approved in 2003) based on a solid-state Nd:YAG source emitting near-infrared (NIR) radiation at a wavelength of 1064 nm. The device operates with a mean power of 10.5 W and a peak power of 3 kW. Three treatment areas (each measuring 15 × 10 cm) will be targeted: two longitudinal areas over the quadriceps muscle and one transverse area over the knee joint. The treatment will be delivered at a frequency of 15 Hz, with a total energy dose of 2000 J, corresponding to an energy density of 4.5 J/cm². The total treatment time will be 14 minutes and 30 seconds.

Device: High level laser therapy

Sham laser therapy group

SHAM COMPARATOR

The sham laser intervention will be delivered using the same HIRO TT device and identical treatment procedures as the active HILT group. The same anatomical areas (two longitudinal areas over the quadriceps muscle and one transverse area over the knee joint) will be targeted, with identical session duration and positioning. During sham treatment, the device will remain switched on; however, no therapeutic laser emission will be delivered. This approach is intended to ensure participant blinding by replicating the visual and procedural aspects of the active intervention without providing any active therapeutic effect.

Other: Sham laser therapy

Interventions

High level laser therapy DEVICE

High-intensity laser therapy (HILT) will be delivered using the HIRO TT device (ASA S.r.l.), which employs a patented pulsed laser system (FDA-approved in 2003) based on a solid-state Nd:YAG source emitting near-infrared (NIR) radiation at a wavelength of 1064 nm. The device operates with a mean power of 10.5 W and a peak power of 3 kW. Three treatment areas (each measuring 15 × 10 cm) will be targeted: two longitudinal areas over the quadriceps muscle and one transverse area over the knee joint. The treatment will be delivered at a frequency of 15 Hz, with a total energy dose of 2000 J, corresponding to an energy density of 4.5 J/cm². The total treatment time will be 14 minutes and 30 seconds.

High level laser therapy group

Sham laser therapy OTHER

The sham laser intervention will be delivered using the same HIRO TT device and identical treatment procedures as the active HILT group. The same anatomical areas (two longitudinal areas over the quadriceps muscle and one transverse area over the knee joint) will be targeted, with identical session duration and positioning. During sham treatment, the device will remain switched on; however, no therapeutic laser emission will be delivered. This approach is intended to ensure participant blinding by replicating the visual and procedural aspects of the active intervention without providing any active therapeutic effect.

Sham laser therapy group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Lisa Berti, MD

CONTACT

0516366197; lisa.berti@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 5, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

IT (1)