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Effectiveness of Conservative Interventions in the Treatment of Trigger Finger

H

Hacettepe University

Status

Enrolling

Conditions

Trigger Finger
Stenosing Tenosynovitis

Treatments

Other: Extracorporeal Shock Wave Therapy+ Trigger Finger Splint
Other: Experimental: Extracorporeal Shock Wave Therapy
Other: Trigger Finger Splint

Study type

Interventional

Funder types

Other

Identifiers

NCT06296017
AEŞH- EK1- 2023-115

Details and patient eligibility

About

There is no study in the literature comparing the effectiveness of ESWT and splint therapy, which are the most commonly used approaches in the treatment of Trigger Finger (TF). The aim in this study is to investigate the effectiveness of ESWT and splint therapy used in the treatment of TF.

Full description

Volunteer patients who were clinically diagnosed with trigger finger by consulting a doctor at Etlik City Hospital, Hand Surgery Clinic will be included in the randomized controlled prospective study. Patients will be randomly divided into three groups using the 'Random Sequence Generator tab' on Random.org, a randomization website, and different treatment programs will be applied. ESWT application to a group; splint treatment with ESWT to the second group; The third group will receive only splint treatment. ESWT application will be performed on A1 puley at 15 Hz, 1000 shock wave impuls and 2.0 bar level, for a total of 5 sessions, one week apart. In addition to ESWT with the same parameters, a trigger finger splint that immobilizes the MCP joint will be recommended to the ESWT and splint treatment group. The patient will be asked to use this splint throughout the day for 8 weeks. The Splint Group will be offered the same trigger finger splint and will be asked to use it throughout the day for 8 weeks. Evaluation and measurements will be repeated for all three groups before treatment, immediately after treatment (8th week) and 4 weeks after the end of treatment (12th week). The number of individuals to participate in the study was calculated as 54 in total, with 18 people in each group (ESWT Group, ESWT+ Splint Group and Splint Group), according to the power and sample size analysis based on 80% power and 5% Type 1 error rate. Power analysis was performed based on pain intensity as the clinical endpoint.

Enrollment

54 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Volunteering
  • Being between the ages of 18-65
  • Being diagnosed with stage 1 or stage 2 (according to the Froimson classification) trigger finger
  • Having the language and cognitive skills to answer the questionnaires used in the evaluation

Exclusion criteria

  • Being pregnant
  • Having an inflammatory disorder
  • Having had surgery on the hand/wrist
  • Having a neurological disease
  • NSAIDs, painkillers, etc. being on medication
  • De Quervain's tenosynovitis, carpal tunnel syndrome

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54 participants in 3 patient groups

Extracorporeal Shock Wave Therapy
Experimental group
Description:
Extracorporeal Shock Wave Therapy (ESWT for short) application will be performed on A1 pulley at 15 Hz, 1000 shock wave impulses, and 2.0 bar level, for a total of 5 sessions, one week apart.
Treatment:
Other: Experimental: Extracorporeal Shock Wave Therapy
Trigger Finger Splint
Experimental group
Description:
A trigger finger splint that immobilizes the MCF joint will be recommended for the splint treatment group. The patient will be asked to use this splint throughout the day for 8 weeks.
Treatment:
Other: Trigger Finger Splint
Extracorporeal Shock Wave Therapy+Trigger Finger Splint
Experimental group
Description:
Splint treatment will be applied together with ESWT. ESWT application will be performed on A1 pulley at 15 Hz, 1000 shock wave impulses, and 2.0 bar level, in a total of 5 sessions, one week apart. A trigger finger splint that immobilizes the MCF joint will be recommended for the splint treatment group. The patient will be asked to use this splint throughout the day for 8 weeks.
Treatment:
Other: Extracorporeal Shock Wave Therapy+ Trigger Finger Splint

Trial contacts and locations

1

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Central trial contact

Feray Karademir; Tüzün Fırat

Data sourced from clinicaltrials.gov

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