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Completed

NCT Number: NCT04767724

Extracorporeal Shock Wave Versus Local Corticosteroid Injection for Carpal Tunnel Syndrome

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).

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Shock Wave Sprains and Strains Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang ZJ, 315000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Local corticosteroid injection

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

Sponsors and collaborators

Lead sponsor

Chinese Medical Association

Network

Registry information

Official study title

A Prospective Randomized Controlled Clinical Trial Comparing the Extracorporeal Shock Wave and Local Corticosteroid Injection for Carpal Tunnel Syndrome

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 23, 2021
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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