Carpal Tunnel Syndrome, Shock Wave
Conditions
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.
Interventions
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.
Sponsors
Chinese Medical Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | 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. |
| Boston Carpal Tunnel Questionnaire (BCTQ) | 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. |
| The peak latency of the median sensory nerve action potential (SNAP) | 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 amplitude of the median sensory nerve action potential | 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 distal latency of the median compound motor action potential (CMAP) | 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 amplitude of the median compound motor action potential | 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. |
Countries
China
Outcome results
None listed