- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Merve Yıldız, MD
- Numer telefonu: +905350229993
- E-mail: merveyildizdr@gmail.com
Lokalizacje studiów
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Istanbul, Turcja (Türkiye), 34098
- Rekrutacyjny
- Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine
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Kontakt:
- Merve Yıldız, MD
- Numer telefonu: +905350229993
- E-mail: merveyildizdr@gmail.com
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Główny śledczy:
- Merve Yıldız, MD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: 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.
Inne nazwy:
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Aktywny komparator: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in pain intensity assessed by Numeric Rating Scale (NRS)
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in triggering severity assessed by Modified Quinnell classification
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby układu mięśniowo-szkieletowego
- Choroby mięśni
- Tendinopatia
- Zaburzenie palca spustowego
- Uwięzienie ścięgna
- Hormony
- Hormony, substytuty hormonów i antagoniści hormonów
- Węglowodany
- Związki policykliczne
- Ciąży
- Ciężarne
- Steroidy
- Związki sterownika
- Sterydy, fluorowane
- Ciąży
- Cukry
- Heksozy
- Monosacharydy
- Betametazon
- Glukoza
- Hormony kory nadnerczy
Inne numery identyfikacyjne badania
- TF-Dextrose-2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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