このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Low-Level Laser Therapy in the Treatment of Trigger Finger

2026年8月4日 更新者:Nihan ERDINC GUNDUZ、Dokuz Eylul University

Effectiveness of Low-Level Laser Therapy for Trigger Finger: A Randomized Double-Blind Sham-Controlled Trial

Trigger finger, also known as stenosing tenosynovitis, is one of the most common disorders affecting the hand. Its lifetime prevalence is 2-3%. Patients typically present with locking of the affected finger during flexion and painful catching during extension. In mild cases, pain, swelling, and morning stiffness may be present without triggering. In more severe cases, the affected finger may become locked in flexion.

Conservative treatment methods, corticosteroid injections, and surgical interventions can be used in the treatment of trigger finger. Conservative treatment options include activity modification, splint immobilization, exercise programs, massage, physical therapy modalities including extracorporeal shock wave therapy and therapeutic ultrasound, and nonsteroidal anti-inflammatory drugs (NSAIDs). Splinting is an inexpensive and effective treatment option for trigger finger.

Low-level laser therapy (LLLT) is a treatment modality based on photobiomodulation, which leads to biological changes in living organisms through the interaction of photons with atoms or molecules. LLLT is used to promote wound healing and tissue repair, prevent tissue damage, reduce inflammation and edema, and provide analgesia. Several studies have demonstrated the effectiveness of LLLT in the treatment of various musculoskeletal disorders.

This study aims to investigate the effects of adding active LLLT to splint treatment in patients with trigger finger. Patients receiving active LLLT plus splint treatment will be compared with those receiving sham LLLT plus splint treatment in terms of clinical and ultrasonographic outcomes.

調査の概要

詳細な説明

Trigger finger develops as a result of a size mismatch between the flexor tendon or tendon sheath and the first annular (A1) pulley at the level of the metacarpal head. Although the A1 pulley is the most commonly affected site, triggering may also occur at the second and third annular pulleys (A2 and A3). The diagnosis of trigger finger is made clinically. Musculoskeletal ultrasonography is an adjunctive imaging modality that is increasingly used in the diagnosis of trigger finger. The ultrasonographic findings of trigger finger may include diffuse or nodular hypoechoic thickening of the A1 pulley and increased flexor tendon thickness.

Low-level laser therapy (LLLT) has been shown to be an effective, noninvasive treatment modality for pain reduction in various musculoskeletal disorders. Studies have investigated its effectiveness in the treatment of de Quervain's tenosynovitis, flexor tendon injuries, carpal tunnel syndrome, lateral epicondylitis, plantar fasciitis, and adhesive capsulitis. However, evidence evaluating the effectiveness of LLLT for the treatment of trigger finger remains limited. The literature includes a small, non-randomized, uncontrolled clinical study involving five patients. In addition, a case report described the application of a combination of LLLT, specific hand massage, and hand exercises in a patient with chronic trigger fingers and bilateral carpal tunnel syndrome. Although these studies reported favorable outcomes, high-quality evidence remains limited. To the best of our knowledge, no randomized controlled trials evaluating the use of LLLT for the treatment of trigger finger have been reported in the literature.

This study is a prospective, randomized, double-blind, sham-controlled clinical trial designed to investigate the effects of LLLT on clinical and ultrasonographic outcomes in patients with trigger finger. Adults with a clinical diagnosis of trigger finger who meet the eligibility criteria and provide written informed consent will be enrolled. Following randomization, participants will be assigned to either the active LLLT group or the sham LLLT group. Both groups will receive the same splint treatment during the intervention period. LLLT will be administered three times per week for 4 weeks, for a total of 12 treatment sessions, using a wavelength of 830 nm, an output power of 50 mW, continuous mode, and an energy density of 4 J/cm². Participants in the sham group will undergo the same treatment schedule, with the laser device remaining switched off throughout each session. To maintain participant blinding, participants in both groups will wear headphones and an eye mask during each treatment session. All participants will be provided with a metacarpophalangeal (MCP) joint blocking splint. The splint will block the MCP joint of the affected finger at 0° while allowing unrestricted movement of the interphalangeal joints. Participants will be instructed to wear the splint continuously for 4 weeks and to remove it only for personal hygiene. Compliance with splint use will be monitored using a daily diary in which participants will record the number of hours they wear the splint each day. The average daily wearing time will be calculated at the end of the treatment period. Participants will be allowed to continue their usual daily and work-related activities while avoiding movements that aggravate triggering symptoms or excessive use of the affected hand. Paracetamol will be permitted as rescue medication if needed, and its use will be recorded throughout the study.

Before treatment, demographic and clinical information, including age, sex, body mass index, affected hand, affected finger, symptom duration, and previous history of trigger finger, will be documented. Outcome measures will include pain intensity assessed with the Visual Analog Scale (VAS), triggering severity assessed with the Quinnell Classification, triggering frequency determined by the number of triggering events during 10 consecutive active full-fist movements, the Trigger Finger Assessment Scale (TFAS), the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire, hand grip strength, patient satisfaction, and ultrasonographic measurements of A1 pulley thickness and flexor tendon thickness. Ultrasonographic assessments will be performed by a single experienced investigator, who will be blinded to treatment allocation. All clinical outcome assessments will also be conducted by an investigator blinded to treatment allocation.

研究の種類

介入

入学 (推定)

91

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

研究連絡先のバックアップ

研究場所

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:

  • Applying to the outpatient clinic of the Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Dokuz Eylül University
  • A clinical diagnosis of trigger finger based on typical pain and tenderness over the A1 pulley accompanied by triggering of the affected finger
  • Willingness to participate in the study

Exclusion Criteria:

  • Multiple trigger fingers in the same hand
  • Fixed deformity (Quinnell grade 4)
  • Splint treatment, physical therapy, or steroid injection for the affected trigger finger within the previous 6 months
  • Previous surgery for the affected trigger finger
  • Musculoskeletal disorders or peripheral nerve injury involving the ipsilateral upper extremity
  • Rheumatoid arthritis, carpal tunnel syndrome, Dupuytren disease, amyloidosis, or mucopolysaccharidosis
  • Active infection, bleeding, skin lesions, or an implant at the treatment site
  • Radiotherapy within the previous 6 months
  • Photodermatosis, photosensitivity, or systemic lupus erythematosus
  • Pregnancy, epilepsy, coagulopathy, active malignancy, or the presence of a cardiac pacemaker
  • Cognitive impairment that precludes understanding of the study questionnaires.

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:ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的:Low Level Laser Therapy
Low-level laser therapy will be administered three times per week for 4 weeks using a BTL-4000 Smart laser therapy device and the following treatment parameters: a wavelength of 830 nm, an output power of 50 mW, continuous mode, and an energy density of 4 J/cm².

Low-level laser therapy will be administered three times per week for 4 weeks using a BTL-4000 Smart laser therapy device and the following treatment parameters: a wavelength of 830 nm, an output power of 50 mW, continuous mode, and an energy density of 4 J/cm².

All participants will also receive a metacarpophalangeal joint blocking splint for 4 weeks.

他の名前:
  • Low Level Laser Treatment
偽コンパレータ:Sham Low Level Laser Therapy
Sham low-level laser therapy will be administered three times per week for 4 weeks, for a total of 12 sessions, using a BTL-4000 Smart laser therapy device that will remain switched off throughout each session.

Sham low-level laser therapy will be administered three times per week for 4 weeks, for a total of 12 sessions, using a BTL-4000 Smart laser therapy device that will remain switched off throughout each session. To maintain participant blinding, participants in both groups will wear headphones and an eye mask during each treatment session.

All participants will also receive a metacarpophalangeal joint blocking splint for 4 weeks.

他の名前:
  • Sham Low Level Laser Treatment

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 Analog Scale
時間枠:All participants will be assessed at four time points: at baseline, immediately after completion of treatment, 1 month after treatment, and 3 months after treatment.
Changes in trigger finger pain will be assessed using the Visual Analog Scale. Scores range from 0 to 10 cm, with higher scores indicating greater pain intensity.
All participants will be assessed at four time points: at baseline, immediately after completion of treatment, 1 month after treatment, and 3 months after treatment.
Quinnell Classification
時間枠:All participants will be assessed at four time points: at baseline, immediately after completion of treatment, 1 month after treatment, and 3 months after treatment.
The severity of triggering will be assessed using the Quinnell Classification: Grade 0, normal movement of the digit; Grade 1, uneven movement; Grade 2, actively correctable locking of the digit; Grade 3, passively correctable locking; and Grade 4, fixed deformity. Higher grades indicate greater triggering severity.
All participants will be assessed at four time points: at baseline, immediately after completion of treatment, 1 month after treatment, and 3 months after treatment.
Trigger Finger Assessment Scale
時間枠:All participants will be assessed at four time points: at baseline, immediately after completion of treatment, 1 month after treatment, and 3 months after treatment.

The Trigger Finger Assessment Scale consists of three separate 0-to-10-point scales that assess the frequency, severity, and functional impact of triggering. Higher scores on each scale indicate more frequent or severe triggering or greater functional impact.

Scale reference: Tarbhai K, Hannah S, von Schroeder HP. Trigger finger treatment: a comparison of 2 splint designs. J Hand Surg Am. 2012;37(2):243-249.

All participants will be assessed at four time points: at baseline, immediately after completion of treatment, 1 month after treatment, and 3 months after treatment.
Number of Triggering Events During 10 Active Full Fist Movements
時間枠:All participants will be assessed at four time points: at baseline, immediately after completion of treatment, 1 month after treatment, and 3 months after treatment.
The number of triggering events during 10 consecutive active full fist movements will be recorded (0-10).
All participants will be assessed at four time points: at baseline, immediately after completion of treatment, 1 month after treatment, and 3 months after treatment.

二次結果の測定

結果測定
メジャーの説明
時間枠
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
時間枠:All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment
The QuickDASH is an 11-item questionnaire used to assess physical function and symptoms. Each item is scored on a 5-point Likert scale, and the total score ranges from 0 to 100, with higher scores indicating greater disability.
All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment
Hand Grip Strength
時間枠:All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment.
Hand grip strength will be assessed using a Jamar hydraulic hand dynamometer. Three measurements will be performed on the affected hand, with a 1-minute rest interval between each measurement, and the mean of the three measurements will be recorded.
All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment.
A1 Pulley Thickness
時間枠:All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment
A1 pulley thickness will be measured using ultrasonography in the longitudinal plane. The measurement will be taken at the thickest part of the A1 pulley.
All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment
Flexor Tendon Thickness
時間枠:All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment.

Flexor tendon thickness will be measured using ultrasonography in the longitudinal plane at three points:

  • A1 pulley tunnel inlet: metacarpal head-neck junction.
  • A1 pulley tunnel outlet: proximal phalangeal base-shaft junction.
  • A1 pulley tunnel (interpulley): middle of inlet and outlet.

Reference: Chiang CH, Kuo LC, Kuo YL, Wu KC, Shao CJ, Chern TC, Jou IM. The value of high-frequency ultrasonographic imaging for quantifying trigger digits: a correlative study with clinical findings in patients with different severity grading. Ultrasound Med Biol. 2013;39(6):967-974.

All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment.
Patient Satisfaction
時間枠:All participants will be assessed at three time points: immediately after completion of treatment, 1 month after treatment, and 3 months after treatment.
Patient satisfaction will be assessed using a 5-point scale with the following response options: completely satisfied, almost satisfied, moderately satisfied, somewhat satisfied, and dissatisfied.
All participants will be assessed at three time points: immediately after completion of treatment, 1 month after treatment, and 3 months after treatment.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディチェア:Elif Akalın, Prof, MD、Dokuz Eylul University

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 (実際)

2025年8月7日

一次修了 (推定)

2026年8月1日

研究の完了 (推定)

2026年12月1日

試験登録日

最初に提出

2026年8月4日

QC基準を満たした最初の提出物

2026年8月4日

最初の投稿 (実際)

2026年8月7日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月7日

QC基準を満たした最後の更新が送信されました

2026年8月4日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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。

購読する