A Prospective Randomized Controlled Clinical Trial Comparing the Extracorporeal Shock Wave and Local Corticosteroid Injection for Carpal Tunnel Syndrome
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Chinese Medical Association
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- The amplitude of the median sensory nerve action potential
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Extracorporeal shock wave (Device)
Local corticosteroid injection
A single injection of one mL (40 mg) of betamethasone into the region surrounding the median nerve.
Intervention: Extracorporeal shock wave (Device)
Outcomes
Primary Outcomes
The amplitude of the median sensory nerve action potential
Time Frame: 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.
Boston Carpal Tunnel Questionnaire (BCTQ)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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.
Visual Analog Scale (VAS)
Time Frame: At baseline (before the treatment)
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)
Time Frame: At 6 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.
Boston Carpal Tunnel Questionnaire (BCTQ)
Time Frame: At baseline (before the treatment)
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)
Time Frame: At 6 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 peak latency of the median sensory nerve action potential (SNAP)
Time Frame: At baseline (before the treatment)
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)
Time Frame: At 6 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
Time Frame: At baseline (before the treatment)
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
Time Frame: At 6 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.
The distal latency of the median compound motor action potential (CMAP)
Time Frame: At baseline (before the treatment)
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)
Time Frame: At 6 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
Time Frame: At baseline (before the treatment)
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
Time Frame: At 6 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.
Secondary Outcomes
No secondary outcomes reported