Extracorporeal Shock Wave Versus Local Corticosteroid Injection for Carpal Tunnel Syndrome

NCT04767724 | Completed Phase 4 DMC

• 1 other identifier: LH2017-012
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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).

Conditions

Carpal Tunnel Syndrome; Shock Wave

Outcome Measures

Primary Outcomes (18)

• 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

Study Arms (2)

Extracorporeal shock wave

EXPERIMENTAL

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

Local corticosteroid injection

ACTIVE COMPARATOR

A single injection of one mL (40 mg) of betamethasone into the region surrounding the median nerve.

Device: Extracorporeal shock wave

Interventions

Extracorporeal shock wave DEVICE

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.

Also known as: Local corticosteroid injection

Extracorporeal shock wave; Local corticosteroid injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Medical Association: lead

Study Sites (1)

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang ZJ, 315000, China

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Jin Li, MD

  Ningbo Medical Center Lihuili Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 23, 2021
• Study Start: April 10, 2018
• Primary Completion: August 2, 2019
• Study Completion: April 10, 2020
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starts on Aug 30, 2019, and will last for 3 years.

Locations

CN (1)