Extracorporeal Shock Wave Versus Local Corticosteroid Injection for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

A Prospective Randomized Controlled Clinical Trial Comparing the Extracorporeal Shock Wave and Local Corticosteroid Injection for Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04767724
• Other study ID #: LH2017-012
• Status: Completed
• Phase: Phase 4
• Start date: April 10, 2018
• Est. completion date: April 10, 2020

Study information

• Verified date: February 2021
• Source: Chinese Medical Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 10, 2020
• Est. primary completion date: August 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Shock
• Shock Wave
• Syndrome

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Ningbo Medical Center Lihuili Hospital	Ningbo	Zhejiang ZJ

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Medical Association

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	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.	At baseline (before the treatment)
Primary	Visual Analog Scale (VAS)	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.	At 6 months after the treatments
Primary	Visual Analog Scale (VAS)	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.	At 12 months after the treatments
Primary	Boston Carpal Tunnel Questionnaire (BCTQ)	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.	At baseline (before the treatment)
Primary	Boston Carpal Tunnel Questionnaire (BCTQ)	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.	At 6 months after the treatments
Primary	Boston Carpal Tunnel Questionnaire (BCTQ)	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.	At 12 months after the treatments
Primary	The peak latency of the median sensory nerve action potential (SNAP)	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.	At baseline (before the treatment)
Primary	The peak latency of the median sensory nerve action potential (SNAP)	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.	At 6 months after the treatments
Primary	The peak latency of the median sensory nerve action potential (SNAP)	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.	At 12 months after the treatments
Primary	The amplitude of the median sensory nerve action potential	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.	At baseline (before the treatment)
Primary	The amplitude of the median sensory nerve action potential	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.	At 6 months after the treatments
Primary	The amplitude of the median sensory nerve action potential	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.	At 12 months after the treatments
Primary	The distal latency of the median compound motor action potential (CMAP)	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.	At baseline (before the treatment)
Primary	The distal latency of the median compound motor action potential (CMAP)	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.	At 6 months after the treatments
Primary	The distal latency of the median compound motor action potential (CMAP)	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.	At 12 months after the treatments
Primary	The amplitude of the median compound motor action potential	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.	At baseline (before the treatment)
Primary	The amplitude of the median compound motor action potential	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.	At 6 months after the treatments
Primary	The amplitude of the median compound motor action potential	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.	At 12 months after the treatments