Focused Extracorporeal Shock Wave Therapy (ESWT) Versus Traditional Physiotherapy in the Treatment of Trigger Finger

NCT04855942 | Withdrawn

• 1 other identifier: (811)109A-50
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Trigger Finger; Stenosing Tenosynovitis

Keywords

extracorporeal shock wave; trigger finger; stenosing tenosynovitis

Outcome Measures

Primary Outcomes (5)

• Quinnell stages of triggering

  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).

  15 weeks

• 11-point numeric scale of pain

  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.

  15 weeks

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

  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.

  15 weeks

• strength of hand grip

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

  15 weeks

• sonographic image

  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.

  15 weeks

Study Arms (2)

Focused Extracorporeal Shock Wave Therapy (ESWT)

EXPERIMENTAL

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

Device: Focused Extracorporeal Shock Wave Therapy (ESWT)

Physiotherapy

ACTIVE COMPARATOR

therapeutic ultrasound, 12 times in 3 weeks

Device: physiotherapy

Interventions

Focused Extracorporeal Shock Wave Therapy (ESWT) DEVICE

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

Focused Extracorporeal Shock Wave Therapy (ESWT)

physiotherapy DEVICE

therapeutic ultrasound, 12 times in 3 weeks

Physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cheng-Hsin General Hospital: lead

MeSH Terms

Conditions

Trigger Finger Disorder; Tendon Entrapment

Interventions

Extracorporeal Shockwave Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Rehabilitation

Study Design

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

Model Details: Our study design is mainly to compare the therapeutic effect to trigger finger between extracorporeal shock wave (PiezoWave2 ECO, produced by Richard Wolf) and traditional physiotherapy.

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: April 22, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: August 31, 2022
• Last Updated: July 25, 2022

Record last verified: 2022-07