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Extracorporeal Shock Wave Versus Local Corticosteroid Injection for Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome, Shock Wave

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Extracorporeal shock wave
Sponsored by
Chinese Medical Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Ningbo Medical Center Lihuili Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Extracorporeal shock wave

Local corticosteroid injection

Arm 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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 10, 2021
Last Updated
February 25, 2021
Sponsor
Chinese Medical Association
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1. Study Identification

Unique Protocol Identification Number
NCT04767724
Brief Title
Extracorporeal Shock Wave Versus Local Corticosteroid Injection for Carpal Tunnel Syndrome
Official Title
A Prospective Randomized Controlled Clinical Trial Comparing the Extracorporeal Shock Wave and Local Corticosteroid Injection for Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 10, 2018 (Actual)
Primary Completion Date
August 2, 2019 (Actual)
Study Completion Date
April 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chinese Medical Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Shock Wave

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extracorporeal shock wave
Arm Type
Experimental
Arm 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
Arm Title
Local corticosteroid injection
Arm Type
Active Comparator
Arm Description
A single injection of one mL (40 mg) of betamethasone into the region surrounding the median nerve.
Intervention Type
Device
Intervention Name(s)
Extracorporeal shock wave
Other Intervention Name(s)
Local corticosteroid injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
At baseline (before the treatment)
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
At 6 months after the treatments
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
At 12 months after the treatments
Title
Boston Carpal Tunnel Questionnaire (BCTQ)
Description
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.
Time Frame
At baseline (before the treatment)
Title
Boston Carpal Tunnel Questionnaire (BCTQ)
Description
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.
Time Frame
At 6 months after the treatments
Title
Boston Carpal Tunnel Questionnaire (BCTQ)
Description
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.
Time Frame
At 12 months after the treatments
Title
The peak latency of the median sensory nerve action potential (SNAP)
Description
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.
Time Frame
At baseline (before the treatment)
Title
The peak latency of the median sensory nerve action potential (SNAP)
Description
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.
Time Frame
At 6 months after the treatments
Title
The peak latency of the median sensory nerve action potential (SNAP)
Description
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.
Time Frame
At 12 months after the treatments
Title
The amplitude of the median sensory nerve action potential
Description
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.
Time Frame
At baseline (before the treatment)
Title
The amplitude of the median sensory nerve action potential
Description
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.
Time Frame
At 6 months after the treatments
Title
The amplitude of the median sensory nerve action potential
Description
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.
Time Frame
At 12 months after the treatments
Title
The distal latency of the median compound motor action potential (CMAP)
Description
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.
Time Frame
At baseline (before the treatment)
Title
The distal latency of the median compound motor action potential (CMAP)
Description
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.
Time Frame
At 6 months after the treatments
Title
The distal latency of the median compound motor action potential (CMAP)
Description
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.
Time Frame
At 12 months after the treatments
Title
The amplitude of the median compound motor action potential
Description
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.
Time Frame
At baseline (before the treatment)
Title
The amplitude of the median compound motor action potential
Description
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.
Time Frame
At 6 months after the treatments
Title
The amplitude of the median compound motor action potential
Description
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.
Time Frame
At 12 months after the treatments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patients aged ≥18 years Should present a new episode of CTS with symptoms lasting for ≥ six weeks Symptoms include wrist pain, numbness, and paraesthesia on the hands Tested postive by the Phalen test and Tinel test Electrodiagnostically diagnosed with mild to moderate CTS Exclusion Criteria: A lack of consent information A history of a CTS surgery or LCI in the carpal tunnel Asystemic disease that may interfere with the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Li, MD
Organizational Affiliation
Ningbo Medical Center Lihuili Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ningbo Medical Center Lihuili Hospital
City
Ningbo
State/Province
Zhejiang ZJ
ZIP/Postal Code
315000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Details of interventions, data of the results
IPD Sharing Time Frame
Starts on Aug 30, 2019, and will last for 3 years.

Learn more about this trial

Extracorporeal Shock Wave Versus Local Corticosteroid Injection for Carpal Tunnel Syndrome

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