Arthroplasty ComplicationsNCT07568262
The Effectiveness of High-intensity Laser Therapy on Post-surgical Rehabilitation After Total Knee Arthroplasty
A study testing High level laser therapy in people with Arthroplasty Complications and Pain, Postoperative, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Arthroplasty Complications, Pain, Postoperative
- What is being tested?
- High level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Psychiatric disorders
- Cognitive impairments
- Previous major trauma or surgery involving the affected knee
- Rheumatic diseases or fibromyalgia
- Vascular diseases
- Neoplastic diseases
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effectiveness of High-intensity Laser Therapy on Post-surgical Rehabilitation: a Randomized Controlled 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.
Read more
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
- Being tested
- High level laser therapy, Sham laser therapy
- Keywords
- Total knee arthroplasty, High-level laser therapy, Laser therapy, Post-operative pain, Rehabilitation, Physical therapy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High level laser therapyDevice
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.
Sham laser therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 3 weeks
Secondary outcomes (5)
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.
Measured: Baseline, after 1 week, after 2 weeks, after 4 months follow-up
Range of Motion
Knee range of motion (ROM) will be assessed bilaterally, both actively and passively, including maximum flexion and full extension.
Measurements will be obtained using a digital goniometer. The axis of rotation will be aligned with the lateral femoral condyle. The stationary arm will be aligned with the longitudinal axis of the femur, using the greater trochanter as a proximal reference point, while the movable arm will be aligned with the longitudinal axis of the fibula, using the fibular head and lateral malleolus as reference points.
ROM values will be recorded in degrees, with higher flexion values and lower extension deficits indicating better joint mobility.
Measured: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Swelling
Knee swelling will be assessed using circumferential measurements (cm) obtained with a flexible measuring tape.
Measurements will be performed with the participant in the supine position and the lower limbs in full extension. Circumference will be recorded at standardized anatomical landmarks: 1 cm below the inferior pole of the patella (knee joint line), 10 cm and 20 cm above the patellar base, and 5 cm below the patellar apex.
Two measurements will be taken at each site, and the mean value will be used for analysis. Higher circumference values will indicate greater swelling.
Measured: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Lower limb muscle strength
Lower limb muscle strength will be assessed using a handheld dynamometer during isometric knee extension and flexion of the operated limb.
Participants will perform three maximal voluntary isometric contractions for each movement, each lasting 5 seconds, with a 30-second rest interval between repetitions. The mean value of the three trials will be used for analysis.
For knee extension assessment, participants will be seated with the hip and knee flexed at 90°. For knee flexion assessment, participants will be positioned prone with the knee flexed at 90°. In both conditions, limb positioning will be standardized using a digital goniometer and stabilized with a fixation strap.
The dynamometer will be placed at the distal third of the leg, approximately 10 cm proximal to the ankle joint. The device will be manually stabilized by the assessor to ensure consistent positioning and minimize compensatory movements.
Higher values will indicate greater muscle strength.
Measured: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Western Ontario and McMaster Universities Osteoarthritis Index
The WOMAC is a patient-reported outcome measure specifically designed for individuals with knee osteoarthritis. It consists of three subscales assessing pain, stiffness, and physical function. The physical function subscale includes items related to activities of daily living such as walking, stair use, sitting, and standing.
Each item is scored on a Likert scale, and total scores are calculated by summing item responses. Higher scores indicate worse pain, stiffness, and functional limitation.
Measured: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568262
- Sponsor's protocol ID
- LASER_KNEE
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of High-intensity Laser Therapy on Post-surgical Rehabilitation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07568262
- Acronym / sponsor ID
- LASER_KNEE
- Conditions
- Arthroplasty Complications, Pain, Postoperative
- Keywords
- Total knee arthroplasty, High-level laser therapy, Laser therapy, Post-operative pain, Rehabilitation, Physical therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High level laser therapy group | Experimental | Device: High level laser therapyHigh-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. |
| Sham laser therapy group | Sham comparator | Other: Sham laser therapyThe 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (22 listed)
- Psychiatric disorders
- Cognitive impairments
- Previous major trauma or surgery involving the affected knee
- Rheumatic diseases or fibromyalgia
- Vascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High level laser therapyHigh-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 group |
| Sham laser therapyThe 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 group |
Primary outcome
Visual Analogue Scale
Time frame: after 3 weeks
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.
5 secondary outcomes
Visual Analogue Scale
Time frame: Baseline, after 1 week, after 2 weeks, after 4 months follow-up
Range of Motion
Time frame: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Swelling
Time frame: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Lower limb muscle strength
Time frame: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High level laser therapy in people with Arthroplasty Complications and Pain, Postoperative, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Berti, MD (0516366197, lisa.berti@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: after 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.