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

NCT06746974 | Not Yet Recruiting

• 1 other identifier: MURA2024/819
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Trigger Finger; Shockwave Therapy

Keywords

trigger finger; shockwave

Outcome Measures

Primary Outcomes (1)

• 100-mm. horizontal VAS score

  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 Outcomes (2)

• QuickDASH score

  at enrollment, fourth week, and sixth week after first intervention

• Number of triggering

  at enrollment, fourth week, and sixth week after first intervention

Study Arms (2)

Shockwave

EXPERIMENTAL

Device: Shockwave

Splint

ACTIVE COMPARATOR

Device: Splint

Interventions

Shockwave 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.

Shockwave

Splint 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.

Splint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Trigger thumb
• The patients who had received previous treatment (steroid injection, ESWT or surgical release)
• Patients with local infections, malignancies, severe coagulopathy and pregnancy

Sponsors & Collaborators

• Mahidol University: lead

Related Publications (7)

• 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.

  PMID: 26763271 BACKGROUND

• 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.

  PMID: 37870373 BACKGROUND

• 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.

  PMID: 30030005 BACKGROUND

• 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.

  PMID: 34029555 BACKGROUND

• 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.

  PMID: 32210646 BACKGROUND

• 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.

  PMID: 32732655 BACKGROUND

• 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.

  PMID: 22189188 BACKGROUND

MeSH Terms

Conditions

Trigger Finger Disorder

Interventions

Splints

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Central Study Contacts

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

CONTACT

6622011154; apisara.kee@mahidol.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share