Effectiveness of Conservative Interventions in the Treatment of Trigger Finger
- Conditions
- Trigger FingerStenosing Tenosynovitis
- Interventions
- Other: Extracorporeal Shock Wave Therapy+ Trigger Finger SplintOther: Trigger Finger Splint
- Registration Number
- NCT06296017
- Lead Sponsor
- Hacettepe University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 54
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Extracorporeal Shock Wave Therapy+Trigger Finger Splint Extracorporeal Shock Wave Therapy+ Trigger Finger Splint 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. Trigger Finger Splint 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.
- Primary Outcome Measures
Name Time Method Visual analog scale pre-treatment and post-treatment at 8 week 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').
- Secondary Outcome Measures
Name Time Method Functional assessment pre-treatment and post-treatment at 8 weeks 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.
Treatment satisfaction pre-treatment and post-treatment at 8 weeks 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.
1. Excellent: I have no pain, I can do my movements and activities fully, I benefited from the treatment.
2. Good: I have some discomfort, but I can do my movements and activities fully, my complaints have decreased after the treatment.
3. 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.
4. Bad: I cannot do activities due to my pain, I did not benefit from the treatment.Number of trigger pre-treatment and post-treatment at 8 weeks 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.
Grip and pinch strength pre-treatment and post-treatment at 8 weeks 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.
Trial Locations
- Locations (1)
Feray Karademir
🇹🇷Ankara, Turkey