Extracorporeal Shock Wave Versus Local Corticosteroid Injection for Carpal Tunnel Syndrome

Overview

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).

Full Title of Study: “A Prospective Randomized Controlled Clinical Trial Comparing the Extracorporeal Shock Wave and Local Corticosteroid Injection for Carpal Tunnel Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 2, 2019

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

  • Device: Extracorporeal shock wave
    • 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.

Arms, Groups and Cohorts

  • Experimental: 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
  • Active Comparator: Local corticosteroid injection
    • A single injection of one mL (40 mg) of betamethasone into the region surrounding the median nerve.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • 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.
  • 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 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 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.
  • 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 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.
  • 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 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 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.
  • 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.

Participating in This Clinical Trial

Inclusion Criteria

The patients aged ≥18 years and presented a new episode of CTS with symptoms lasting for ≥ six weeks, including wrist pain, numbness, and paraesthesia on the hands were examined by the Phalen test and Tinel test, and the ones who tested positive were referred to a physical medicine specialist for electrodiagnostic evaluation. The patients 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; and (3) a systemic disease that may interfere with the study.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese Medical Association
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jin Li, MD, Study Chair, Ningbo Medical Center Lihuili Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.