Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

28 kwietnia 2026 zaktualizowane przez: Istituto Ortopedico Rizzoli

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.

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.

Przegląd badań

Typ studiów

Interwencyjne

Zapisy (Szacowany)

46

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

      • Bologna, Włochy, 40136
        • IRCCS Istituto Ortopedico Rizzoli

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: High level laser therapy group

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-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.

Pozorny komparator: Sham laser therapy group

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.

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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Visual Analogue Scale
Ramy czasowe: 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.
after 3 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Visual Analogue Scale
Ramy czasowe: Baseline, after 1 week, after 2 weeks, after 4 months follow-up
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.
Baseline, after 1 week, after 2 weeks, after 4 months follow-up
Range of Motion
Ramy czasowe: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up

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.

Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Swelling
Ramy czasowe: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up

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.

Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Lower limb muscle strength
Ramy czasowe: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up

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.

Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up
Western Ontario and McMaster Universities Osteoarthritis Index
Ramy czasowe: Baseline, after 1 week, after 2 weeks, after 3 weeks, after 4 months follow-up

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.

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 września 2027

Ukończenie studiów (Szacowany)

1 września 2028

Daty rejestracji na studia

Pierwszy przesłany

28 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

28 kwietnia 2026

Pierwszy wysłany (Rzeczywisty)

5 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

28 kwietnia 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Ból, pooperacyjny

Badania kliniczne na High level laser therapy

Subskrybuj