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Extracorporeal Shock Wave in the Treatment of Trigger Finger

NCT03928873 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-04-26

No results posted yet for this study

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

Interventions

DEVICE

Low energy ESWT

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

DEVICE

High energy ESWT

1500 impulses and 0.01mJ/mm2, 5.8bar, 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

Sponsors & Collaborators

  • Taipei Medical University WanFang Hospital

    lead OTHER

Principal Investigators

  • Yu-Pin Chen, M.D. · Taipei Medical University WanFang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-20
Primary Completion
2019-11-22
Completion
2019-11-22

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03928873 on ClinicalTrials.gov