- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06382623
Efficacies of Different Managements in Patients With Trigger Finger
Comparing the Effectiveness of Peritendinous Steroid Injection Under Ultrasound Guidance With Percutaneous A1 Pulley Release in Trigger Finger Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was designed as a randomized, controlled, prospective study. Patients who had been experiencing trigger finger symptoms for at least one month and who presented to the Gaziler Physical Medicine and Rehabilitation Training and Research Hospital, affiliated with the Health Sciences University Faculty of Medicine
Patients were randomly divided into two groups: the peritendinous steroid group (n=15) and the percutaneous pulley release group (n=15). In the first group, under ultrasound guidance, a mixture of 1 ml corticosteroid (2 mg+5 mg/ml betamethasone) and 1 ml local anesthetic (20 ml 2% prilocaine) was injected peritendinously between the A1 pulley and the flexor tendon sheath. In the second group, a percutaneous A1 pulley release procedure was performed under ultrasound guidance using a 20 G needle, followed by peritendinous injection of the same mixture of corticosteroid and local anesthetic.
Patients were evaluated four times: before treatment, at 1 week, 1 month, and 3 months after treatment. Modified Quinnel classification, VAS (Visual Analog Scale), and severity of locking scales were used as outcome measures in the study.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being over 18 years of age
- Having had trigger finger complaints for more than 1 month
- Not having received any injections for trigger finger diagnosis within the last 1 month
- Signing the informed consent form indicating willingness to participate in the study
Exclusion Criteria:
- Refusing to participate in the study
- Presence of partial or complete tendon rupture in the relevant tendon of the finger to be treated
- Presence of wounds and infection in the area where the procedure will be performed
- Pregnancy status
- History of allergy to the injected medications (local anesthetic, steroid)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
The peritendinous steroid group
A 1 ml mixture of corticosteroid (2 mg + 5 mg/ml betamethasone) and 1 ml of local anesthetic agent (20 ml 2% prilocaine) was injected peritendinously between the A1 pulley and the flexor tendon sheath at the metacarpophalangeal joint level under ultrasound guidance.
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USG-guided injection of corticosteroid between the A1 pulley and the flexor tendon sheath.
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The percutaneous A1 pulley release group
In the A1 pulley release group, 1 ml of local anesthetic agent (20 ml 2% prilocaine) was injected into the pulley-associated subcutaneous tissue using a 27 G needle under ultrasound guidance.
The metacarpophalangeal joint was brought into slight hyperextension.
Subsequently, a 20 G 0.9x38mm needle, modified by bending approximately 40-45 degrees from the proximal 1/3 of the needle with the aid of a cap, was used.
The needle was advanced in-plane from distal to proximal along the midline, with simultaneous movement towards the palmar surface, aiming to cut or loosen the pulley between the tendon and A1 pulley.
The loosening procedure was repeated from the distal to proximal aspect of the pulley until the sensation of resistance at the needle tip disappeared.
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Ultrasound-guided percutaneous pulley release is a procedure aimed at loosening the pulley using various cutting instruments or hypodermic needles under ultrasound guidance.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stage of the disease
Time Frame: first week, first mount, third month
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Modified Quinnel classification Stage 1: Normal movement, no pain.
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first week, first mount, third month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: first week, first month, third month
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The pain associated with movement in the relevant finger was evaluated using the Visual Analog Scale (VAS).
Patients were explained that "0" represented no pain at all, "10" represented the most severe pain they had ever experienced in their life, and "5" represented moderate pain.
They were asked to indicate a number between 0 and 10 that corresponded to the intensity of pain they were feeling.
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first week, first month, third month
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severity of triggering
Time Frame: first week, first month, third month
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The severity of catching in patients was assessed using a Numeric Rating Scale (NRS) ranging from 0 to 10. Patients were explained that "0" represents no catching at all, while "10" represents catching requiring passive correction of the finger.
They were asked to mark a number between 0 and 10 corresponding to the severity of catching they experienced.
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first week, first month, third month
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Collaborators and Investigators
Investigators
- Principal Investigator: zeliha gizem mac, MD, university of health sciences, Department of PM&R
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 43
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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