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- Ensaio Clínico NCT07753460
Low-Level Laser Therapy in the Treatment of Trigger Finger
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Gözde Kırım Kaya, MD
- Número de telefone: +902324123951
- E-mail: gozde.kirimkaya@deu.edu.tr
Estude backup de contato
- Nome: Nihan Erdinç Gündüz, Ass. Prof. MD
- Número de telefone: +902324123952
- E-mail: nihan.erdincgunduz@deu.edu.tr
Locais de estudo
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Balçova
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Izmir, Balçova, Turquia (Türkiye), 35330
- Recrutamento
- Dokuz Eylul University
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Contato:
- Gözde Kırım Kaya, MD
- E-mail: gozde.kirimkaya@deu.edu.tr
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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.
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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.
Outros nomes:
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Comparador Falso: 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.
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Visual Analog Scale
Prazo: 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.
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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.
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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.
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Quinnell Classification
Prazo: 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.
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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.
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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.
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Trigger Finger Assessment Scale
Prazo: 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.
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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.
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Number of Triggering Events During 10 Active Full Fist Movements
Prazo: 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.
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The number of triggering events during 10 consecutive active full fist movements will be recorded (0-10).
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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.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Prazo: All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment
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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.
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All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment
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Hand Grip Strength
Prazo: All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment.
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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.
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All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment.
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A1 Pulley Thickness
Prazo: All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment
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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.
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All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment
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Flexor Tendon Thickness
Prazo: All participants will be assessed at three time points: at baseline, immediately after completion of treatment, and 1 month after treatment.
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Flexor tendon thickness will be measured using ultrasonography in the longitudinal plane at three points:
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.
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Patient Satisfaction
Prazo: All participants will be assessed at three time points: immediately after completion of treatment, 1 month after treatment, and 3 months after treatment.
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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.
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All participants will be assessed at three time points: immediately after completion of treatment, 1 month after treatment, and 3 months after treatment.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Elif Akalın, Prof, MD, Dokuz Eylul University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
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Outros números de identificação do estudo
- 2025/12-03
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