Extracorporeal Shock Wave in the Treatment of Trigger Finger

April 23, 2019 updated by: Taipei Medical University WanFang Hospital

Extracorporeal Shock Wave Therapy Versus Placebo in the Treatment of Trigger Finger: a Randomized Controlled Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Trigger finger (TF) (also known as stenosing tenovaginitis) is characteristic of triggering, snapping, or locking on flexion of the involved metacarpophalangeal joint of finger, with incidence of 2%-3% in the general population and approximately 10% in diabetic patients. A variety of treatments have been described, including activity restriction, stretching exercise, splitting, non-steroid anti-inflammatory drugs, steroid injection, percutaneous or open release. However, none of the above-mentioned treatments is absolutely better than the others. The most effective treatment for this common disorder is still under debate.

Recently, extracorporeal shock wave therapy (ESWT) is getting popular as an alternative to surgery for the treatment of musculoskeletal disorders in patients recalcitrant to traditional conservative treatment. ESWT has been reported to effectively treat orthopedic disorders, such as plantar fasciitis, lateral epicondylitis of the elbow, calcific tendinopathies of the shoulder, and the non-union of long bone fractures. Biologically, ESWT is believed to result in a mechanosensitive feedback between the acoustic impulse and the stimulated cells, involving specific transduction pathways and gene expression. Furthermore, previous studies have shown that increased angiogenetic growth factors with ESWT are causally related to enhanced neovascularization and blood supply in the tendinopathy area of the tendon. ESWT can also induce the repair of the inflamed tissues by tissue regeneration and stimulates nitric oxide synthase, leading to suppression of ongoing inflammation in the soft tissues. However, there are still few clinical evidence on ESWT in treatment of TF in the literature.

One randomized control study reported the efficacy of ESWT in treatment of TF in 2016, and claimed that ESWT was as effective as steroid injection in treatment of TF. However, this clinical study was limited to the lack of control group with placebo treatment, since steroid injection for TF is reported to be with short-term effect and only effective in 57% of patients. Further evidence on the efficacy of ESWT in treatment of TF is needed to be clarified. In addition, the ideal energy set-up and protocol for ESWT are still left to be proven.

Considering the noninvasive advantage and potentially biological effect on the thickening of the flexor tendon and its sheath, the investigators hypothesize ESWT is effective on relieving the symptoms of TF. 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 determine the efficacy of ESWT in the treatment of TF and to find out the ideal energy set-up of ESWT for TF treatment.

Study Type

Interventional

Enrollment (Anticipated)

60

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

Study Locations

  • Taiwan
      • Taipei, Taiwan, 116
        • Recruiting
        • Taipei Medical University WanFang Hospital
        • Contact:
          • Yu-pin Chen, MD
          • Phone Number: +886933296411

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Previous treatment by physical therapy, local corticosteroid injection, or surgical release for trigger finger before the study
  2. The presence of a musculoskeletal disease or previous nerve injuries at the upper extremities
  3. Multiple trigger finger; local infection; malignancy; inflammatory arthritis; cardiac arrhythmia or cardiac pacemaker; 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
Experimental: Low energy ESWT
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
1500 impulses and 0.006mJ/mm2, 3bar, once per week for 4 weeks
Other Names:
  • "LITEMED"LM-ESWT-mini System
Experimental: High energy ESWT
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
1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks
Other Names:
  • "LITEMED"LM-ESWT-mini System
Sham Comparator: Sham treatment
All participants will receive sham treatment using ESWT Probe with only vibration without transferring energy once per week for 4 weeks.
Device: Sham ESWT
sham treatment using ESWT Probe with only vibration without transferring energy once per week for 4 weeks
Other Names:
  • "LITEMED"LM-ESWT-mini System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficacy of ESWT in the treatment of trigger finger
Time Frame: Baseline and Post-treatment 1, 3, 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of Function Shoulder, and Hand questionnaire (qDASH)
Time Frame: Baseline and Post-treatment 1, 3, 6 months
Functional evaluation utilizing the Quick-Disabilities of the Arm (q-DASH). The QuickDASH uses 11 items (scored 1-5) to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. A higher score means worse disability.
Baseline and Post-treatment 1, 3, 6 months
The change of Pain
Time Frame: Baseline and Post-treatment 1, 3, 6 months
evaluation utilizing Visual analogue scale (VAS). The visual analog scale (VAS) is an instrument regularly used to measure pain intensity based on a 0-10 cm. In the present trial, the researcher asked the patients: "Based on VAS, how much pain are you in/ experiencing?". The higher score means the more severe pain.
Baseline and Post-treatment 1, 3, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University WanFang Hospital

Investigators

  • Principal Investigator: Yu-Pin Chen, M.D., Taipei Medical University WanFang Hospital

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

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 (Actual)

February 20, 2019

Primary Completion (Anticipated)

November 22, 2019

Study Completion (Anticipated)

November 22, 2019

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

April 23, 2019

First Posted (Actual)

April 26, 2019

Study Record Updates

Last Update Posted (Actual)

April 26, 2019

Last Update Submitted That Met QC Criteria

April 23, 2019

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N201810059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all collected IPD, all IPD that underlie results in a publication

IPD Sharing Time Frame

starting 6 months after publication; ending 36 months after publication

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

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.

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