Extracorporeal Shock Wave Versus Local Corticosteroid Injection for Carpal Tunnel Syndrome

Chinese Medical Association

Status and phase: Completed; Phase 4

Conditions: Shock Wave; Carpal Tunnel Syndrome

Treatments: Device: Extracorporeal shock wave

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04767724

LH2017-012

Details and patient eligibility

About

This RCT is to investigate the clinical effect of extracorporeal shock wave therapy (ESWT) compared to the local corticosteroid injection (LCI) in managing mild to moderate carpal tunnel syndrome (CTS).

Full description

To investigate the effect of extracorporeal shock wave therapy (ESWT) compared to the local corticosteroid injection (LCI) in managing mild to moderate carpal tunnel syndrome (CTS). About 50-60 patients with mild to moderate CTS are supposed to be randomly allocated into either ESWT group or LCI group. The outcomes include the visual analog scale (VAS), the Boston Carpal Tunnel Questionnaire (BCTQ), and nerve conduction study at baseline and at 3 weeks, 9 weeks, 12 weeks, 6 months, and 12 months after the treatments.

Enrollment: 55 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The patients aged ≥18 years

1. Should present a new episode of CTS with symptoms lasting for ≥ six weeks
2. Symptoms include wrist pain, numbness, and paraesthesia on the hands
3. Tested postive by the Phalen test and Tinel test
4. Electrodiagnostically diagnosed with mild to moderate CTS

Exclusion criteria

1. A lack of consent information
2. A history of a CTS surgery or LCI in the carpal tunnel
3. Asystemic disease that may interfere with the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 2 patient groups

Extracorporeal shock wave

Experimental group

Description:

Participants received three ESWT sessions once per week for three consecutive weeks. The probe of the ESWT machine (FT-174; Swiss Dolor Class; Switzerland) was placed perpendicularly on the patient's palm over the median nerve on the carpal tunnel after application of the ultrasound gel as a coupling agent. Afterward, the ESWT was administered with 1000 shots, 1.5 bar of pressure, and a frequency of 6 Hz

Treatment:

Device: Extracorporeal shock wave

Local corticosteroid injection

Active Comparator group

Description:

A single injection of one mL (40 mg) of betamethasone into the region surrounding the median nerve.

Treatment:

Device: Extracorporeal shock wave