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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06382623
Other study ID # 43
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date June 30, 2023

Study information

Verified date June 2024
Source Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to compare the effectiveness of peritendinous steroid injection under ultrasound guidance and percutaneous A1 pulley release procedures in terms of disease stage, pain, and severity of locking in patients with trigger finger.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
The percutaneous A1 pulley release
Ultrasound-guided percutaneous pulley release is a procedure aimed at loosening the pulley using various cutting instruments or hypodermic needles under ultrasound guidance.
Other:
The peritendinous Betamethasone group
USG-guided injection of corticosteroid between the A1 pulley and the flexor tendon sheath.

Locations

Country Name City State
Turkey Gaziler Physical Medicine and Rehabilitation Education and Research Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stage of the disease Modified Quinnel classification Stage 1: Normal movement, no pain.
Stage 2: Normal movement, occasional pain.
Stage 3: Irregular movement (catching without crepitus or locking).
Stage 4: Locking present, actively correctable.
Stage 5: Locking present, passively correctable.
first week, first mount, third month
Secondary Pain intensity 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. first week, first month, third month
Secondary severity of triggering 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. first week, first month, third month
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