Extracorporeal Shock Wave Versus Local Corticosteroid Injection for Carpal Tunnel Syndrome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Shock Wave, Carpal Tunnel Syndrome

Intervention / Treatment
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* Device: Extracorporeal shock wave


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extracorporeal shock wave<br>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 | Device: Extracorporeal shock wave<br>* 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.<br>* Other names: Local corticosteroid injection;|
| Active Comparator: Local corticosteroid injection<br>A single injection of one mL (40 mg) of betamethasone into the region surrounding the median nerve. | Device: Extracorporeal shock wave<br>* 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.<br>* Other names: Local corticosteroid injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 
| 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 |