Extracorporeal Shock Wave Versus Local Corticosteroid Injection for Carpal Tunnel Syndrome

NCT ID: NCT04767724

Last Updated: 2021-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-10
• Study Completion Date: 2020-04-10

Brief Summary

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).

Detailed 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.

Conditions

Carpal Tunnel Syndrome; Shock Wave

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Extracorporeal shock wave

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

Group Type: EXPERIMENTAL

Extracorporeal shock wave

Intervention Type: DEVICE

Participants received 3 ESWT sessions once per week for 3 consecutive weeks or a single injection of one mL (40 mg) of betamethasone into the region surrounding the median nerve.

Local corticosteroid injection

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

Group Type: ACTIVE_COMPARATOR

Extracorporeal shock wave

Intervention Type: DEVICE

Participants received 3 ESWT sessions once per week for 3 consecutive weeks or a single injection of one mL (40 mg) of betamethasone into the region surrounding the median nerve.

Interventions

Extracorporeal shock wave

Participants received 3 ESWT sessions once per week for 3 consecutive weeks or a single injection of one mL (40 mg) of betamethasone into the region surrounding the median nerve.

Intervention Type: DEVICE

Other Intervention Names

Local corticosteroid injection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Medical Association

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jin Li, MD

Role: STUDY_CHAIR

Ningbo Medical Center Lihuili Hospital

Locations

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang ZJ, China

Countries

China

Other Identifiers

LH2017-012

Identifier Type: -

Identifier Source: org_study_id