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

2026年4月28日 更新者: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.

調査の概要

研究の種類

介入

入学 (推定)

46

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

      • Bologna、イタリア、40136
        • IRCCS Istituto Ortopedico Rizzoli

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

偽コンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Visual Analogue Scale
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Visual Analogue Scale
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2027年9月1日

研究の完了 (推定)

2028年9月1日

試験登録日

最初に提出

2026年4月28日

QC基準を満たした最初の提出物

2026年4月28日

最初の投稿 (実際)

2026年5月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月5日

QC基準を満たした最後の更新が送信されました

2026年4月28日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

痛み、術後の臨床試験

High level laser therapyの臨床試験

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