- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07681804
Betamethasone vs Dextrose Injections in Trigger Finger
Comparison of Ultrasound-Guided Betamethasone and Dextrose Injections in the Treatment of Trigger Finger: A Randomized Controlled Trial
This study aims to compare the effectiveness of ultrasound-guided betamethasone and dextrose injections in patients with trigger finger.
Trigger finger is a common hand condition characterized by pain, clicking, and locking of the finger due to tendon entrapment at the A1 pulley. Corticosteroid injections are widely used as a first-line treatment; however, they may be associated with potential side effects.
Dextrose injection is an alternative treatment that may promote tissue healing through regenerative mechanisms. However, there is limited high-quality evidence regarding its effectiveness in trigger finger.
In this randomized controlled trial, patients will be assigned to receive either betamethasone or dextrose injection under ultrasound guidance. The primary outcome will be pain intensity measured by the Numeric Rating Scale (NRS). Secondary outcomes will include triggering severity, hand function, grip and pinch strength, and fine motor skills evaluated over a 12-week follow-up period.
The results of this study may help determine whether dextrose injection is a safe and effective alternative to corticosteroid treatment in trigger finger.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Trigger finger, also known as stenosing tenosynovitis, is a common hand disorder characterized by pain, catching, and locking of the affected digit due to impaired gliding of the flexor tendon at the A1 pulley. It can significantly impair hand function and quality of life.
Corticosteroid injections are widely accepted as an effective first-line treatment for trigger finger. However, potential adverse effects such as skin atrophy, tendon rupture, and systemic effects, particularly in patients with metabolic disorders, have led to increasing interest in alternative treatment options.
Dextrose injection has emerged as a potential alternative treatment modality in musculoskeletal disorders. However, there is limited high-quality evidence evaluating its effectiveness in trigger finger.
The aim of this prospective, randomized controlled trial is to compare the clinical effectiveness of ultrasound-guided betamethasone injection and dextrose injection in patients with trigger finger.
Eligible participants aged 18 to 75 years with clinically diagnosed trigger finger of at least 4 weeks' duration will be enrolled. Patients will be randomly assigned to one of two groups. One group will receive an ultrasound-guided injection of 1 ml lidocaine and 1 ml betamethasone, while the other group will receive an ultrasound-guided injection of 1 ml lidocaine and 1 ml 30% dextrose solution (resulting in a final concentration of 15% dextrose). All injections will be performed under sterile conditions at the A1 pulley level.
The study is designed as a randomized, participant-, injector-, and assessor-blinded trial. The injector will be blinded to the injectate using opaque-covered syringes. Randomization will be performed by an independent researcher who will not be involved in outcome assessment.
The primary outcome of the study is the change in pain intensity, assessed using the Numeric Rating Scale (NRS).
Secondary outcomes include triggering severity assessed using the Modified Quinnell classification, functional status assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire, grip and pinch strength, and fine motor skills evaluated with the Purdue Pegboard test.
Outcome assessments will be conducted at baseline, 1 hour, 2 weeks, 4 weeks, and 12 weeks after injection, according to the predefined schedule of each outcome measure.
This study is expected to provide high-quality evidence regarding the effectiveness of dextrose injection as a potential alternative to corticosteroid treatment in trigger finger.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Merve Yıldız, MD
- Numero di telefono: +905350229993
- Email: merveyildizdr@gmail.com
Luoghi di studio
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Istanbul, Turchia (Türkiye), 34098
- Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine
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Contatto:
- Merve Yıldız, MD
- Numero di telefono: +905350229993
- Email: merveyildizdr@gmail.com
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Investigatore principale:
- Merve Yıldız, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Age between 18 and 75 years
- Clinical diagnosis of trigger finger
- Presence of symptoms for at least 4 weeks
Exclusion Criteria:
- Previous surgery on the affected finger
- Injection treatment to the affected finger within the previous 3 months
- Active local or systemic infection
- Active malignancy
- Active inflammatory rheumatic disease (e.g., rheumatoid arthritis, ankylosing spondylitis, polymyalgia rheumatica, vasculitis)
- Uncontrolled diabetes mellitus and/or uncontrolled hypertension
- Autoimmune connective tissue diseases (e.g., systemic lupus erythematosus, antiphospholipid syndrome, systemic sclerosis, Sjögren syndrome, polymyositis, dermatomyositis, adult-onset Still's disease)
- Coagulopathy that increases the risk of injection procedures
- Pregnancy
- Known allergy or hypersensitivity to lidocaine, betamethasone, or dextrose
- Mental impairment or severe psychiatric disorder that may interfere with study participation or informed consent
Piano di studio
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 |
|---|---|
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Comparatore attivo: Betamethasone Injection
Participants in this arm will receive an ultrasound-guided injection of 1 ml lidocaine combined with 1 ml betamethasone at the A1 pulley level for the treatment of trigger finger.
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Ultrasound-guided injection of 1 ml lidocaine combined with 1 ml betamethasone administered at the A1 pulley level for the treatment of trigger finger.
Altri nomi:
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Comparatore attivo: Dextrose Injection
Participants in this arm will receive an ultrasound-guided injection of 1 ml lidocaine combined with 1 ml 30% dextrose solution (final concentration 15%) at the A1 pulley level for the treatment of trigger finger.
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Ultrasound-guided injection of 1 ml lidocaine combined with 1 ml 30% dextrose solution resulting in a final concentration of 15% dextrose, administered at the A1 pulley level for the treatment of trigger finger.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in pain intensity assessed by Numeric Rating Scale (NRS)
Lasso di tempo: Baseline, 1 hour, 2 weeks, 4 weeks, and 12 weeks
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Pain intensity will be evaluated using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates worst imaginable pain.
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Baseline, 1 hour, 2 weeks, 4 weeks, and 12 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in triggering severity assessed by Modified Quinnell classification
Lasso di tempo: Baseline, 2 weeks, 4 weeks, and 12 weeks
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Triggering severity will be evaluated using the Modified Quinnell classification system.
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Baseline, 2 weeks, 4 weeks, and 12 weeks
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Change in hand function assessed by QuickDASH
Lasso di tempo: Baseline, 2 weeks, 4 weeks, and 12 weeks
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Functional status will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire.
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Baseline, 2 weeks, 4 weeks, and 12 weeks
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Change in grip strength
Lasso di tempo: Baseline, 2 weeks, 4 weeks, and 12 weeks
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Grip strength will be measured using a hand dynamometer.
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Baseline, 2 weeks, 4 weeks, and 12 weeks
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Change in pinch strength
Lasso di tempo: Baseline, 2 weeks, 4 weeks, and 12 weeks
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Pinch strength will be measured using a pinch meter.
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Baseline, 2 weeks, 4 weeks, and 12 weeks
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Change in fine motor skills assessed by Purdue Pegboard test
Lasso di tempo: Baseline, 4 weeks, and 12 weeks
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Fine motor skills and manual dexterity will be evaluated using the Purdue Pegboard test.
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Baseline, 4 weeks, and 12 weeks
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- Liu DH, Tsai MW, Lin SH, Chou CL, Chiu JW, Chiang CC, Kao CL. Ultrasound-Guided Hyaluronic Acid Injections for Trigger Finger: A Double-Blinded, Randomized Controlled Trial. Arch Phys Med Rehabil. 2015 Dec;96(12):2120-7. doi: 10.1016/j.apmr.2015.08.421. Epub 2015 Sep 1.
- Rahman AN, Herman H, Bujangga KG, Sugiarto J. Grade III bilateral trigger thumbs treated by prolotherapy: a case report. World Journal of Current Medical and Pharmaceutical Research. 2022;4(6):143-146.
- Yoon Y, Hwang JH, Lee J, Suryadi T, Suhaimi A, Shim J, Lam KHS. Unusual Triggering of the Finger Caused by Distal Flexor Tendinopathy: Successful Treatment With Ultrasound-Guided Prolotherapy. Cureus. 2025 Dec 19;17(12):e99605. doi: 10.7759/cureus.99605. eCollection 2025 Dec.
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie muscoloscheletriche
- Malattie muscolari
- Tendinopatia
- Disturbo del dito a scatto
- Intrappolamento del tendine
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Carboidrati
- Composti policiclici
- Incinta
- In gravidanza
- Steroidi
- Composti anelli fusi
- Steroidi, fluorurati
- Incintadienetrioli
- Zuccheri
- Esosi
- Monosaccaridi
- Betametasone
- Glucosio
- Ormoni della corteccia surrenale
Altri numeri di identificazione dello studio
- TF-Dextrose-2026
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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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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