Comparing the Effects of Extracorporeal Shockwave Therapy and Splinting in the Treatment of Trigger Finger
December 18, 2024 updated by: Mahidol University
The goal of this study is to compare the effects of extracorporeal shockwave therapy and splinting in the treatment of trigger finger.
Participants will:
Be randomized into two groups (shockwave group and splint group). Visit the clinic once a week for four weeks for therapy. Keep a diary of their symptoms, which will be reviewed at six weeks.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Apisara Keesukphan, M.D., MS.c.,
- Phone Number: 6622011154
- Email: apisara.kee@mahidol.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients age ≥ 18 years
- Grade I-III trigger finger patients (patients who has the presence of tenderness over the A1 pulley or painful locking or triggering as they fixed and extended the finger)
- Patients who consented to participation in the study
Exclusion Criteria:
- Trigger thumb
- The patients who had received previous treatment (steroid injection, ESWT or surgical release)
- Patients with local infections, malignancies, severe coagulopathy and pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Splint
|
In the splinting group, will be provided a PIP blocking splint at least 8 hours per day for 6 weeks with the sham shockwave (the patients close their eyes, extend their hand through a partition, apply shockwave device head with gel on the patient's finger, and play a mobile phone sound that mimics the sound of a real shockwave machine) once a week for 4 weeks.
|
|
Experimental: Shockwave
|
In the Shockwave group, will be applied focused shockwaves therapy of 1500 impulses at 0.01 mJ/mm2 over the painful area or the pathologic flexor tendon to each participant under the supervision of a physiatrist.
The ESWT will be conducted once weekly for 4 weeks with a sham splint (DIP joint blocking splints) for at least 8 hours per day for 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
100-mm. horizontal VAS score
Time Frame: at enrollment, fourth week, and sixth week after first intervention
|
The VAS or Visual Analog Scale is a scale that is used to evaluate the level of pain.
It is represented by a horizontal line that is 100-mm.
long.
The score is determined by measuring the distance in mm.
A higher score on this scale indicates greater pain intensity.
|
at enrollment, fourth week, and sixth week after first intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
QuickDASH score
Time Frame: at enrollment, fourth week, and sixth week after first intervention
|
The QuickDASH or Quick Disabilities of the Arm, Shoulder and Hand is a questionnaire that is used to evaluate the ability to perform activities of the arm, shoulder, and hand.
It consists of 11 questions that patients are required to answer all of them.
The answers are summarized in a range of 0-100, where a higher score indicates greater disability.
|
at enrollment, fourth week, and sixth week after first intervention
|
|
Number of triggering
Time Frame: at enrollment, fourth week, and sixth week after first intervention
|
The number of triggering events in ten active full fists will be scored out of ten.
If a participant's finger remain locked at any time in making ten active full fists, they will be asked to stop and given a score of 10/10
|
at enrollment, fourth week, and sixth week after first intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tarbhai K, Hannah S, von Schroeder HP. Trigger finger treatment: a comparison of 2 splint designs. J Hand Surg Am. 2012 Feb;37(2):243-9, 249.e1. doi: 10.1016/j.jhsa.2011.10.038. Epub 2011 Dec 20.
- 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.
- Chen YP, Lin CY, Kuo YJ, Lee OK. Extracorporeal Shockwave Therapy in the Treatment of Trigger Finger: A Randomized Controlled Study. Arch Phys Med Rehabil. 2021 Nov;102(11):2083-2090.e1. doi: 10.1016/j.apmr.2021.04.015. Epub 2021 May 21.
- Nadar MS. Orthosis vs. exercise for the treatment of adult idiopathic trigger fingers: A randomized clinical trial. Prosthet Orthot Int. 2024 Dec 1;48(6):713-719. doi: 10.1097/PXR.0000000000000294. Epub 2023 Oct 20.
- Teo SH, Ng DCL, Wong YKY. Effectiveness of proximal interphalangeal joint-blocking orthosis vs metacarpophalangeal joint-blocking orthosis in trigger digit management: A randomized clinical trial. J Hand Ther. 2019 Oct-Dec;32(4):444-451. doi: 10.1016/j.jht.2018.02.007. Epub 2018 Jul 18.
- Vahdatpour B, Momeni F, Tahmasebi A, Taheri P. The Effect of Extracorporeal Shock Wave Therapy in the Treatment of Patients with Trigger Finger. Open Access J Sports Med. 2020 Mar 9;11:85-91. doi: 10.2147/OAJSM.S232727. eCollection 2020.
- Gil JA, Hresko AM, Weiss AC. Current Concepts in the Management of Trigger Finger in Adults. J Am Acad Orthop Surg. 2020 Aug 1;28(15):e642-e650. doi: 10.5435/JAAOS-D-19-00614.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 15, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
November 30, 2026
Study Registration Dates
First Submitted
December 18, 2024
First Submitted That Met QC Criteria
December 18, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 18, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MURA2024/819
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Due to concerns about patient privacy, confidentiality, and ethical obligations
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.