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

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.

Study Overview

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

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey
        • Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

older 18 ages

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: first week, first month, third month
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
severity of triggering
Time Frame: first week, first month, third month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: zeliha gizem mac, MD, university of health sciences, Department of PM&R

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 6, 2024

Last Update Submitted That Met QC Criteria

June 5, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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