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Clinical Trials/NCT04855942
NCT04855942WithdrawnNot Applicable

Focused Extracorporeal Shock Wave Therapy (ESWT) Versus Traditional Physiotherapy in the Treatment of Trigger Finger: a Randomized Controlled Study

Cheng-Hsin General Hospital0 sitesStarted: May 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Primary Endpoint
Chinese quick DASH (disabilities of the Arm, Shoulder, and Hand questionnaire)

Study Overview

Brief Summary

Trigger finger is the common name of stenosing tenosynovitis of fingers, caused by repetitive trauma. Conservative treatment includes NSAIDs or other analgesic agents, activity modification, splint, and physiotherapy. Operation could be considered if conservative treatments fails. With literature reviewed, there is no treatment which is both non-invasive and effective, and also could avoid recurrence well.

Extracorporeal shock wave therapy could induce angiogenesis, anti-inflammatory reaction, and recruitment of fibroblast. Although extracorporeal shock wave has been utilized in musculoskeletal diseases for more than twenty years, there is no well-designed clinical trial to prove the effectiveness of extracorporeal shock wave in treating trigger finger. The purpose of this study is to compare the effectiveness of extracorporeal shock wave therapy with traditional physical therapy for the management of trigger finger.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Quinnel classification grade 2 or 3
  • •who has only one trigger

Exclusion Criteria

  • •who had ever treated the trigger finger
  • •who has other musculoskeletal disease of the upper limb
  • •who has severe coagulopathy disease
  • •who is pregnant
  • •who has arrhythmia or has a pacemaker
  • •there is sensory impairment, scar, edema at the trigger finger
  • •who has cognitive dysfunction

Arms & Interventions

Focused Extracorporeal Shock Wave Therapy (ESWT)

Experimental

2000 impulses of 5 Hz and 0.32 mJ/mm2 , twice per week for 3 weeks

Intervention: Focused Extracorporeal Shock Wave Therapy (ESWT) (Device)

Physiotherapy

Active Comparator

therapeutic ultrasound, 12 times in 3 weeks

Intervention: physiotherapy (Device)

Outcomes

Primary Outcomes

Chinese quick DASH (disabilities of the Arm, Shoulder, and Hand questionnaire)

Time Frame: 15 weeks

This questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The investigators chose the first two components: the disability and symptom section (11 items, scored 1-5). The lower score means better condition of upper limbs, and vice versa.

11-point numeric scale of pain

Time Frame: 15 weeks

The 11-point numeric scale of pain requires the patient to rate their pain on a defined scale. 0 is no pain and 10 is the worst pain imaginable.

Quinnell stages of triggering

Time Frame: 15 weeks

Quinnell stages of triggering classifies the trigger finger using five types during flexion and extension: normal movement (Type 0), uneven movement (Type I), actively correctable (Type II), passively correctable (Type III) and fixed deformity (Type IV).

sonographic image

Time Frame: 15 weeks

The investigators would record the characteristics of acquired sonographic images, such like the thickness of finger flexor tendon and A1 pulley, the presence of tendon sheath effusion, and the presence of increased vascularity by Doppler images.

strength of hand grip

Time Frame: 15 weeks

The strength of hand grip is to measure the maximum isometric strength of the hand and forearm muscles by a electicial grip strength device.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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