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Terapia laser ad alto e basso livello nella tenosinovite di De Quervain

4 novembre 2026 aggiornato da: Sevda Adar, Afyonkarahisar Health Sciences University

Comparison of the Efficacy of High and Low Level Laser Therapy in the Treatment of De Quervain's Tenosynovitis: A Randomized Controlled Trial

The aim in this study was to compare the effects of high and low power laser treatments in the treatment of de Quervein tenosynovitis clinically and ultrasonographically.

Panoramica dello studio

Stato

Iscrizione su invito

Intervento / Trattamento

Descrizione dettagliata

De Quervain's tenosynovitis is tenosynovitis of the abductor pollicis longus (APL) and extensor pollicis brevis (EPB) tendons. Conservative management includes nonsteroidal anti-inflammatory drugs, wrist and thumb immobilization, ultrasound, and low-level laser therapy (LLLT). According to early literature, low-level laser therapy and ultrasound therapy appear to produce similar biological effects in reducing inflammation and promoting tissue healing.

In a study low-power laser therapy was found to be effective compared to placebo in de Quervain's tenosynovitis.

In a study of 35 female patients, low-power laser therapy (LLLT) combined with a thumb-supported splint was not superior to splint alone in patients with de Quervain's tenosynovitis.

In a more recent study low-power laser therapy was found to be similarly effective to ultrasound therapy.

The investigators found no studies in the literature on the effect of high-power laser therapy. The aim in this study was to compare the effects of high and low power laser treatments in the treatment of de Quervein tenosynovitis clinically and ultrasonographically.

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Afyonkarahisar, Turchia (Türkiye)
        • Afyonkarahisar Health Sciences University Health Application and Research Center Physical Medicine and Rehabilitation Clinic

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Between18-65 years of age
  • Wrist pain for more than 3 weeks
  • Finkelstein test positive
  • Ability to understand commands

Exclusion Criteria:

  • Physical therapy, injections, or surgery in the upper extremity in the last 3 months
  • Fracture or trauma in the upper extremity in the last 6 months
  • Radiating pain due to cervical discopathy
  • Infection, loss of sensation, metal implant in the treatment area
  • Inflammatory rheumatic diseases
  • NSAID use
  • Pregnancy or planning pregnancy during treatment
  • Malignancy
  • Pathology in the wrist on radiograph

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: HILT Group

Patients will receive pulsed laser therapy using the HIRO 3 device (ASA Laser, Arcugnano, Italy) five times a week for 3 weeks, one session per day for a total of 15 sessions. The HILT device offers pulsed emission (1064 nm), very high peak power (3 kW), high fluence (energy density 360-1780 mJ/cm2), short duration (120-150 μs), average power of 10.5 W, low frequency (10-40 Hz), duty cycle of approximately 0.1%, a 0.5 cm diameter probe and a spot size of 0.2 cm. A standard handpiece equipped with fixed spacers is used to maintain the same distance from the skin. The 3-stage treatment program is planned to be applied to the 1st CMC joint area in each session.

Patients will do hand-wrist joint range of motion, stretching and strengthening exercises for 20 minutes once a day, under the supervision of the same physiotherapist.

Comparatore attivo: LLLT Group

The MLS Multiwave Locked System laser device will be used for the treatment (low level laser). The laser probe (1 cm in diameter) will be applied directly and perpendicularly and lightly in contact with the skin. LLLT for de quatrein will be applied twice per session. Once the probe will be held in contact with the skin (at the radial styloid) and the second time in scanning mode (approximately 1 inch long along the tendon sheath). The area to be treated will be divided into 1 cm square areas and the optimum anti-inflammatory dosage (3 J/cm) continuous output mode will be used

Patients will do hand-wrist joint range of motion, stretching and strengthening exercises for 20 minutes once a day, under the supervision of the same physiotherapist.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Visual Pain Scale (VAS)
Lasso di tempo: Before treatment (T0), After tratment (3. week) (T1)

Visual Pain Scale (VAS), which is easy to understand, apply and interpret, and provides valid and reliable data in a short time, is the most commonly used method in clinics. With a 100 mm visual linear scale, the patient is told that there is no pain at point 0, and that the most severe pain they have ever felt at point 100, and the patient is asked to put a mark on the point corresponding to their pain.

Before treatment (T0), After tratment (3. week) (T1)
Ritchie Articular Index
Lasso di tempo: Before treatment (T0), After tratment (3. week) (T1)

It is an index developed for the numerical measurement of joint tenderness in patients with rheumatoid arthritis. It is the quantitative evaluation number of the patient's response to the discomfort experienced by the joint when exposed to pressure during passive movement of the joint. It is a 4-point scale; if there is no tenderness (0), the patient complains of pain (1), the patient complains of pain and is accompanied by patient irritation (2), and the patient withdraws with pain and irritation (3). As a result, the total score obtained by summing the clinical evaluation index items made with joint tenderness is recorded.

Before treatment (T0), After tratment (3. week) (T1)
Finkelstein test
Lasso di tempo: Before treatment (T0), After tratment (3. week) (T1)

The Finkelstein test is the occurrence of wrist pain at the level of the radial styloid during ulnar deviation of the wrist with the thumb flexed into the palm and covered with the remaining fingers.

Before treatment (T0), After tratment (3. week) (T1)
Jamar Dynamometer
Lasso di tempo: Before treatment (T0), After tratment (3. week) (T1)

Measurements will be made by sitting with the shoulder adducted and neutrally rotated, adjacent to the body, elbow 90 degrees flexed, wrist 0-30 degrees dorsiflexed and 0-15 degrees ulnar deviation, thumb up. Measurements will be repeated three times with 5-second intervals on the affected hand and the average of the three measurements will be recorded in kilograms. Finger grip strength will be assessed with the 'Jamar digital pinchmeter'.

Before treatment (T0), After tratment (3. week) (T1)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Disabilities of the Arm, Shoulder and Hand Questionnaire (QUICK DASH)
Lasso di tempo: Before treatment (T0), After tratment (3. week) (T1)

It is used to measure physical function and symptoms in patients with upper extremity musculoskeletal disorders.The questionnaire consists of a disability/symptom scale (11 items) and two optional scales: work (four items) and sports/performing arts (four items). Each item on the disability/symptom scale asks about pain intensity, activity-related pain, tingling, weakness and stiffness, difficulty moving, physical activity due to upper extremity problems, and the impact of upper extremity problems on social activities, work and sleep. Responses are given on a one-to-five scale, with each question scored from 1 to 5. From the item scores, scale scores are calculated, ranging from 0 (no disability) to 100 (most severe disability).

Before treatment (T0), After tratment (3. week) (T1)
Ultrasonographic evaluation
Lasso di tempo: Before treatment (T0), After tratment (3. week) (T1)

Ultrasonographic evaluation for both wrists will be performed by the same physiatrist who is unaware of the participant's clinical data and group distribution using the Esaote My Lab 70 Vision USG device with a 7.5 MHz linear probe. The combined thickness of the APL and EPB sheaths will be measured. In addition, the presence of fluid and Doppler activity around the tendon will be assessed. Patients are assessed in a sitting position with both forearms placed on the patient's lap/thigh in a mid-prone position. The scanned area will extend from a few centimeters proximal to the radial styloid to the insertion of the tendons of the first compartment (distal end of the proximal phalanx). Transverse scans will be obtained for measurement of the tendon sheath at the level of the radial styloid.

Before treatment (T0), After tratment (3. week) (T1)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: SEVDA ADAR, Ass. Prof., Afyonkarahisar Health Sciences University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 dicembre 2024

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 gennaio 2027

Date di iscrizione allo studio

Primo inviato

15 novembre 2024

Primo inviato che soddisfa i criteri di controllo qualità

15 novembre 2024

Primo Inserito (Effettivo)

18 novembre 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 novembre 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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