Comparing the Effects of Extracorporeal Shockwave Therapy and Splinting in the Treatment of Trigger Finger

NCT ID: NCT06746974

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Trigger Finger Shockwave Therapy

Keywords

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trigger finger shockwave

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Shockwave

Group Type EXPERIMENTAL

Shockwave

Intervention Type DEVICE

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.

Splint

Group Type ACTIVE_COMPARATOR

Splint

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Apisara Keesukphan, M.D., MS.c.,

Role: CONTACT

Phone: 6622011154

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 26763271 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37870373 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30030005 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34029555 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32210646 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32732655 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22189188 (View on PubMed)

Other Identifiers

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MURA2024/819

Identifier Type: -

Identifier Source: org_study_id