Clinical trial NCT04767724: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carpal Tunnel Syndrome
Shock Wave
Lead sponsor: Chinese Medical Association
Sponsor class: NETWORK
First posted: 2021-02-23
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: At baseline (before the treatment)
measure: Visual Analog Scale (VAS)
timeFrame: At 6 months after the treatments
measure: Visual Analog Scale (VAS)
timeFrame: At 12 months after the treatments
measure: Boston Carpal Tunnel Questionnaire (BCTQ)
timeFrame: At baseline (before the treatment)
measure: Boston Carpal Tunnel Questionnaire (BCTQ)
timeFrame: At 6 months after the treatments
measure: Boston Carpal Tunnel Questionnaire (BCTQ)
timeFrame: At 12 months after the treatments
measure: The peak latency of the median sensory nerve action potential (SNAP)
timeFrame: At baseline (before the treatment)
measure: The peak latency of the median sensory nerve action potential (SNAP)
timeFrame: At 6 months after the treatments
measure: The peak latency of the median sensory nerve action potential (SNAP)
timeFrame: At 12 months after the treatments
measure: The amplitude of the median sensory nerve action potential
timeFrame: At baseline (before the treatment)
measure: The amplitude of the median sensory nerve action potential
timeFrame: At 6 months after the treatments
measure: The amplitude of the median sensory nerve action potential
timeFrame: At 12 months after the treatments
measure: The distal latency of the median compound motor action potential (CMAP)
timeFrame: At baseline (before the treatment)
measure: The distal latency of the median compound motor action potential (CMAP)
timeFrame: At 6 months after the treatments
measure: The distal latency of the median compound motor action potential (CMAP)
timeFrame: At 12 months after the treatments
measure: The amplitude of the median compound motor action potential
timeFrame: At baseline (before the treatment)
measure: The amplitude of the median compound motor action potential
timeFrame: At 6 months after the treatments
measure: The amplitude of the median compound motor action potential
timeFrame: At 12 months after the treatments
Secondary outcomes:
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital
state: Zhejiang ZJ
Study officials:
affiliation: Ningbo Medical Center Lihuili Hospital
name: Jin Li, MD
role: STUDY_CHAIR
References: