Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06296017
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-02-14
Brief Title:
Effectiveness of Conservative Interventions in the Treatment of Trigger Finger
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
Effectiveness of Conservative Interventions in the Treatment of Trigger Finger
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Randomorg 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 20 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None