Clinical trial NCT06296017: Effectiveness of Conservative Interventions in the Treatment of Trigger Finger
Official title: Effectiveness of Conservative Interventions in the Treatment of Trigger Finger
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trigger Finger
Stenosing Tenosynovitis
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual analog scale
timeFrame: pre-treatment and post-treatment at 8 week
Secondary outcomes:
measure: Grip and pinch strength
timeFrame: pre-treatment and post-treatment at 8 weeks
measure: Number of trigger
timeFrame: pre-treatment and post-treatment at 8 weeks
measure: Functional assessment
timeFrame: pre-treatment and post-treatment at 8 weeks
measure: Treatment satisfaction
timeFrame: pre-treatment and post-treatment at 8 weeks
measure: Functional assessment
timeFrame: pre-treatment and post-treatment at 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Feray Karademir
Study officials:
affiliation: Etlik Şehir Hastanesi
name: Kadir ÇEVİK
role: STUDY_DIRECTOR
References:
citation: Bonnici AV, Spencer JD. A survey of 'trigger finger' in adults. J Hand Surg Br. 1988 May;13(2):202-3. doi: 10.1016/0266-7681_88_90139-8.
citation: Sampson SP, Badalamente MA, Hurst LC, Seidman J. Pathobiology of the human A1 pulley in trigger finger. J Hand Surg Am. 1991 Jul;16(4):714-21. doi: 10.1016/0363-5023(91)90200-u.
citation: Makkouk AH, Oetgen ME, Swigart CR, Dodds SD. Trigger finger: etiology, evaluation, and treatment. Curr Rev Musculoskelet Med. 2008 Jun;1(2):92-6. doi: 10.1007/s12178-007-9012-1.
citation: Flatt AE. Notta's nodules and trigger digits. Proc (Bayl Univ Med Cent). 2007 Apr;20(2):143-5. doi: 10.1080/08998280.2007.11928272. No abstract available.
citation: Froimson A. Tenosynovitis and tennis elbow. Operative hand surgery. 1993:1989-2006.
citation: Alsancak S, Güner S, Bilgin S. Efficacy of splinting variations in two different treatment protocols in trigger thumb. JPO: Journal of Prosthetics and Orthotics. 2015;27(1):17-22.
citation: Yildirim P, Gultekin A, Yildirim A, Karahan AY, Tok F. Extracorporeal shock wave therapy versus corticosteroid injection in the treatment of trigger finger: a randomized controlled study. J Hand Surg Eur Vol. 2016 Nov;41(9):977-983. doi: 10.1177/1753193415622733. Epub 2016 Sep 28.