Effectiveness of Conservative Interventions in the Treatment of Trigger Finger

Trigger Finger Clinical Trial

Official title:

Effectiveness of Conservative Interventions in the Treatment of Trigger Finger

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06296017
• Other study ID #: AESH- EK1- 2023-115
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Hacettepe University
• Contact: Feray Karademir
• Phone: +90 505 313 75 82
• Email: karademirferay[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Stenosing Tenosynovitis
• Tendon Entrapment
• Tenosynovitis
• Trigger Finger
• Trigger Finger Disorder

Intervention

Other:
• Experimental: Extracorporeal Shock Wave Therapy
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.
• Trigger Finger Splint
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.
• Extracorporeal Shock Wave Therapy+ Trigger Finger Splint
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. Also, A trigger finger splint that immobilizes the MCF joint will be recommended.

Locations

Country	Name	City	State
Turkey	Feray Karademir	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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.

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. — View 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. — View Citation

Froimson A. Tenosynovitis and tennis elbow. Operative hand surgery. 1993:1989-2006.

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale	The severity of pain felt by individuals at rest and during challenging activities will be evaluated using the Visual Analog Scale (VAS). The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').	pre-treatment and post-treatment at 8 week
Secondary	Grip and pinch strength	Grip Strength Measurement: Standard, tip, lateral and tripod grip strengths will be performed in the test position standardized by the American Association of Hand Therapists. Jamar hand dynamometer and pinchmeter (Pro Med Products, Atlanta, GA, USA) will be used for evaluation. Grip strength will be measured at the 2nd position of the dynamometer. The evaluation will be made three times for each measurement and the average will be recorded in kg.	pre-treatment and post-treatment at 8 weeks
Secondary	Number of trigger	Patients will be asked to open and close their hand ten times and the number of triggers will be recorded out of 10. If the patient's finger becomes locked at any time while making a full fist, they will be asked to stop and a score of 10/10 will be given.	pre-treatment and post-treatment at 8 weeks
Secondary	Functional assessment	The Disabilities of the Arm, Shoulder and Hand Questionnaire: DASH contains thirty items regarding symptoms and activities of daily living. The total score is 100, with higher scores indicating more apology.	pre-treatment and post-treatment at 8 weeks
Secondary	Treatment satisfaction	Roles and Maudsley Score is used to score treatment satisfaction level. The patient is asked to compare his/her pain level before and after treatment and to indicate whether he or she has benefited.; Excellent: I have no pain, I can do my movements and activities fully, I benefited from the treatment.; Good: I have some discomfort, but I can do my movements and activities fully, my complaints have decreased after the treatment.; Acceptable: My pain level has decreased compared to before the treatment, but I feel discomfort after long-term activities. I received little benefit from the treatment.; Bad: I cannot do activities due to my pain, I did not benefit from the treatment.	pre-treatment and post-treatment at 8 weeks
Secondary	Functional assessment	Michigan Hand Outcomes Questionnaire: It consists of six subheadings: general hand function, ADL (unilateral and bilateral), work, pain, aesthetics and satisfaction. Subheadings are filled separately for right and left hands. The score for each title is calculated separately. It is normalized by calculating the percentage of raw scores obtained by summing the scores (0 to 100) given to each question. Higher scores indicate better functional level.	pre-treatment and post-treatment at 8 weeks