Extracorporeal Shock Wave Versus Local Corticosteroid Injection for Carpal Tunnel Syndrome

Phase 4

Completed

• Conditions: Shock Wave; Carpal Tunnel Syndrome
• Interventions: Device: Extracorporeal shock wave

• Registration Number: NCT04767724
• Lead Sponsor: Chinese Medical Association

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.

Study Timeline

• Study Start: 2018-04-10
• Primary Completion: 2019-08-02
• Study Completion: 2020-04-10
• Status Verified: 2021-02
• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-02-21
• Study First Posted: 2021-02-23
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local corticosteroid injection	Extracorporeal shock wave	A single injection of one mL (40 mg) of betamethasone into the region surrounding the median nerve.
Extracorporeal shock wave	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

Primary Outcome Measures

Name	Time	Method
Boston Carpal Tunnel Questionnaire (BCTQ)	At 12 months after the treatments	Boston Carpal Tunnel Questionnaire (BCTQ) is the most widely used self-administered outcome scale in patients with carpal tunnel syndrome (CTS) for assessing patients' perceived symptom severity and functional status. The score ranges from 19 to 95. The higher score means a worse status of CTS.
The distal latency of the median compound motor action potential (CMAP)	At 12 months after the treatments	The distal latency of the median compound motor action potential (CMAP) is used to assess the function status of the median compound motor nerve. The value ranges from 0 ms. The less value means the quicker conduction of the action potential and the better function status of the nerve.
The amplitude of the median compound motor action potential	At 12 months after the treatments	The amplitude of the median compound motor action potential is used to assess the function status of the median compound motor nerve. The value ranges from 0 mV. The higher value means the better function status of the nerve.
Visual Analog Scale (VAS)	At 12 months after the treatments	The Visual Analog Scale (VAS) is frequently used as a tool to measure the degree of the pain felt by the participants. The score ranges from 0 to 10. The higher score means a higher degree of the pain.
The peak latency of the median sensory nerve action potential (SNAP)	At 12 months after the treatments	The peak latency of the median sensory nerve action potential (SNAP) is used to assess the function status of the median sensory nerve. The value ranges from 0 ms. The less value means the quicker conduction of the action potential and the better function status of the nerve.
The amplitude of the median sensory nerve action potential	At 12 months after the treatments	The amplitude of the median sensory nerve action potential is used to assess the function status of the median sensory nerve. The value ranges from 0 μV. The higher value means the better function status of the nerve.

Trial Locations

Locations (1)

Ningbo Medical Center Lihuili Hospital; 🇨🇳 Ningbo, Zhejiang ZJ, China