Extracorporeal Shock Wave in the Treatment of Trigger Finger

NCT03928873 | Unknown

• 1 other identifier: N201810059
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Trigger finger (TF) is a condition that causes triggering, snapping, or locking on flexion of the involved finger, with a life- time risk between 2%-3% in the general population. A variety of treatments have been described, but the most effective treatment for this common disorder is still under debate. Recently, extracorporeal shock wave therapy(ESWT) has been advanced as a possible alternative to surgery for the treatment of musculoskeletal disorders in patients recalcitrant to traditional conservative treatment. However, the effectiveness of ESWT on the treatment of TF is still in lack of evidence. The purpose of this study is to conduct a prospective randomized clinical trial to compare the efficacies of ESWT at two different energy flux density with placebo treatment for the management of TF. The investigators intended to enrolled 60 participants randomly allocated to three groups: low energy ESWT (1500 impulses and 0.006mJ/mm2, 3bar, once per week for 4 weeks), high energy ESWT (1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks) or placebo treatment groups. The effectiveness of the treatment will be assessed using cure rates, a visual analogue scale, the frequency of triggering, the severity of triggering, the functional impact of triggering, and the Quick-Disabilities of the Arm, Shoulder, and Hand questionnaire (qDASH) at 1, 3, and 6 months after treatment. An intention-to-treat analysis will be used in this study. The investigators intend to determine the efficacy of ESWT in the treatment of TF and to find out the ideal energy set-up of ESWT for TF treatment.

Conditions

Trigger Finger

Keywords

shock wave; trigger finger

Outcome Measures

Primary Outcomes (1)

• The efficacy of ESWT in the treatment of trigger finger

  Change from baseline the frequency of triggering, the severity of triggering and the functional impact of triggering at 1, 3, 6 months. We used a trigger finger assessment scale which included three 0- to 10- point subscales to determine the frequency, severity and functional impact of triggering to define the efficacy of treatment. In each subscale, the higher score means worse outcome. (Scale reference: Tarbhai K, Hannah S, von Schroeder HP: Trigger finger treatment: a comparison of 2 splint designs. J Hand Surg Am 2012, 37(2):243-249, 249.e241.)

  Baseline and Post-treatment 1, 3, 6 months

Secondary Outcomes (2)

• The change of Function Shoulder, and Hand questionnaire (qDASH)

  Baseline and Post-treatment 1, 3, 6 months

• The change of Pain

  Baseline and Post-treatment 1, 3, 6 months

Study Arms (3)

Low energy ESWT

EXPERIMENTAL

Low energy ESWT (using LITEMED"LM-ESWT-mini System with 1500 impulses and 0.006mJ/mm2, 3bar, once per week for 4 weeks)

Device: Low energy ESWT

High energy ESWT

EXPERIMENTAL

High energy ESWT (using LITEMED"LM-ESWT-mini System with 1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks)

Device: High energy ESWT

Sham treatment

SHAM COMPARATOR

All participants will receive sham treatment using ESWT Probe with only vibration without transferring energy once per week for 4 weeks.

Device: Sham ESWT

Interventions

Low energy ESWT DEVICE

1500 impulses and 0.006mJ/mm2, 3bar, once per week for 4 weeks

Also known as: "LITEMED"LM-ESWT-mini System

Low energy ESWT

High energy ESWT DEVICE

1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks

Also known as: "LITEMED"LM-ESWT-mini System

High energy ESWT

Sham ESWT DEVICE

sham treatment using ESWT Probe with only vibration without transferring energy once per week for 4 weeks

Also known as: "LITEMED"LM-ESWT-mini System

Sham treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 20 years of age
• Grade 2\~3 trigger finger based on the Quinnell classification

You may not qualify if:

• Previous treatment by physical therapy, local corticosteroid injection, or surgical release for trigger finger before the study
• The presence of a musculoskeletal disease or previous nerve injuries at the upper extremities
• Multiple trigger finger; local infection; malignancy; inflammatory arthritis; cardiac arrhythmia or cardiac pacemaker; and pregnancy.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Taipei Medical University WanFang Hospital

Taipei, 116, Taiwan

RECRUITING

Related Publications (15)

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  PMID: 19687073 BACKGROUND

• Strom L. Trigger finger in diabetes. J Med Soc N J. 1977 Nov;74(11):951-4. No abstract available.

  PMID: 269967 BACKGROUND

• Amirfeyz R, McNinch R, Watts A, Rodrigues J, Davis TRC, Glassey N, Bullock J. Evidence-based management of adult trigger digits. J Hand Surg Eur Vol. 2017 Jun;42(5):473-480. doi: 10.1177/1753193416682917. Epub 2016 Dec 21.

  PMID: 28488453 BACKGROUND

• Romeo P, Lavanga V, Pagani D, Sansone V. Extracorporeal shock wave therapy in musculoskeletal disorders: a review. Med Princ Pract. 2014;23(1):7-13. doi: 10.1159/000355472. Epub 2013 Nov 5.

  PMID: 24217134 BACKGROUND

• Yin M, Chen N, Huang Q, Marla AS, Ma J, Ye J, Mo W. New and Accurate Predictive Model for the Efficacy of Extracorporeal Shock Wave Therapy in Managing Patients With Chronic Plantar Fasciitis. Arch Phys Med Rehabil. 2017 Dec;98(12):2371-2377. doi: 10.1016/j.apmr.2017.05.016. Epub 2017 Jun 17.

  PMID: 28634056 BACKGROUND

• Yang TH, Huang YC, Lau YC, Wang LY. Efficacy of Radial Extracorporeal Shock Wave Therapy on Lateral Epicondylosis, and Changes in the Common Extensor Tendon Stiffness with Pretherapy and Posttherapy in Real-Time Sonoelastography: A Randomized Controlled Study. Am J Phys Med Rehabil. 2017 Feb;96(2):93-100. doi: 10.1097/PHM.0000000000000547.

  PMID: 27323324 BACKGROUND

• Arirachakaran A, Boonard M, Yamaphai S, Prommahachai A, Kesprayura S, Kongtharvonskul J. Extracorporeal shock wave therapy, ultrasound-guided percutaneous lavage, corticosteroid injection and combined treatment for the treatment of rotator cuff calcific tendinopathy: a network meta-analysis of RCTs. Eur J Orthop Surg Traumatol. 2017 Apr;27(3):381-390. doi: 10.1007/s00590-016-1839-y. Epub 2016 Aug 23.

  PMID: 27554465 BACKGROUND

• Alkhawashki HM. Shock wave therapy of fracture nonunion. Injury. 2015 Nov;46(11):2248-52. doi: 10.1016/j.injury.2015.06.035. Epub 2015 Jul 3.

  PMID: 26323379 BACKGROUND

• Cacchio A, Giordano L, Colafarina O, Rompe JD, Tavernese E, Ioppolo F, Flamini S, Spacca G, Santilli V. Extracorporeal shock-wave therapy compared with surgery for hypertrophic long-bone nonunions. J Bone Joint Surg Am. 2009 Nov;91(11):2589-97. doi: 10.2106/JBJS.H.00841.

  PMID: 19884432 BACKGROUND

• Hsu RW, Hsu WH, Tai CL, Lee KF. Effect of shock-wave therapy on patellar tendinopathy in a rabbit model. J Orthop Res. 2004 Jan;22(1):221-7. doi: 10.1016/S0736-0266(03)00138-4.

  PMID: 14656684 BACKGROUND

• Orhan Z, Ozturan K, Guven A, Cam K. The effect of extracorporeal shock waves on a rat model of injury to tendo Achillis. A histological and biomechanical study. J Bone Joint Surg Br. 2004 May;86(4):613-8.

  PMID: 15174564 BACKGROUND

• Seok H, Kim SH. The effectiveness of extracorporeal shock wave therapy vs. local steroid injection for management of carpal tunnel syndrome: a randomized controlled trial. Am J Phys Med Rehabil. 2013 Apr;92(4):327-34. doi: 10.1097/PHM.0b013e31826edc7b.

  PMID: 23044704 BACKGROUND

• 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

• Fleisch SB, Spindler KP, Lee DH. Corticosteroid injections in the treatment of trigger finger: a level I and II systematic review. J Am Acad Orthop Surg. 2007 Mar;15(3):166-71. doi: 10.5435/00124635-200703000-00006.

  PMID: 17341673 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 DERIVED

MeSH Terms

Conditions

Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Yu-Pin Chen, M.D.

  Taipei Medical University WanFang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Pin Chen, M.D.

CONTACT

+886-933296411; 99231@w.tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients will be randomized to each group. All participants are blinded to the treatment groups. All of the outcome will be followed by an assistant who is blinded to the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Our pilot experiment on safety and effectiveness of Extracorporeal shock wave therapy (ESWT), we choose the two energy doses of ESWT for experiment: 1. Low energy ESWT (1500 impulses and 0.006mJ/mm2, 3bar, once per week for 4 weeks) 2. High energy ESWT (1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks) In order to realize the effectiveness of ESWT on trigger finger, we will enroll a placebo group in which all participants will receive ESWT probe treatment with only vibration without transferring energy once per week for 4 weeks.

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: April 26, 2019
• Study Start: February 20, 2019
• Primary Completion: November 22, 2019
• Study Completion: November 22, 2019
• Last Updated: April 26, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: starting 6 months after publication; ending 36 months after publication
• Access Criteria: With whom: For investigators whose proposed use of the data has been approved by an independent committee For what type of analysis: For individual participants meta-analysis For what mechanism: To gain access, data requestor should sign a data access agreement. Data are available for 3 years at third party website.

Locations

TW (1)