- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Merve Yıldız, MD
- Phone Number: +905350229993
- Email: merveyildizdr@gmail.com
Study Locations
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Istanbul, Turkey (Türkiye), 34098
- Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine
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Contact:
- Merve Yıldız, MD
- Phone Number: +905350229993
- Email: merveyildizdr@gmail.com
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Principal Investigator:
- Merve Yıldız, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: 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.
Other Names:
|
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Active Comparator: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in pain intensity assessed by Numeric Rating Scale (NRS)
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in triggering severity assessed by Modified Quinnell classification
Time Frame: Baseline, 2 weeks, 4 weeks, and 12 weeks
|
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Muscular Diseases
- Tendinopathy
- Trigger Finger Disorder
- Tendon Entrapment
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Carbohydrates
- Polycyclic Compounds
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Steroids, Fluorinated
- Pregnadienetriols
- Sugars
- Hexoses
- Monosaccharides
- Betamethasone
- Glucose
- Adrenal Cortex Hormones
Other Study ID Numbers
- TF-Dextrose-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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