CClinicalTrials.gg
WithdrawnNCT03671473Updated Oct 13, 2021

Comparison of Focused and Radial Extracorporeal Shock Wave for Carpal Tunnel Syndrome

An interventional study of Extracorporeal shock wave in Carpal Tunnel Syndrome, sponsored by Tri-Service General Hospital. Withdrawn at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-10-13.

Sponsored by Tri-Service General Hospital · Not applicable, Interventional, and Treatment

Why this study was withdrawn
It is difficult to enroll patients
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
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Study summary

Extracorporeal shock wave is a novel treatment for peripheral nerve entrapment. This study was designed to compare the efficacy of focused and radial extracorporeal shock wave for carpal tunnel syndrome.

Read the detailed description

Both focused and radial extracorporeal shock wave had been proved to treat carpal tunnel syndrome by several studies. However, there was no study comparing these two methods. Considering different mechanisms and costs, this randomized comparative trial would be conducted to compare the efficacy of focused and radial extracorporeal shock wave for carpal tunnel syndrome.

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Conditions studied

  • Carpal Tunnel Syndrome

Keywords

  • Carpal Tunnel Syndrome
  • Extracorporeal shock wave
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In context

Carpal Tunnel Syndrome

589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

Tri-Service General Hospital is the lead sponsor of 109 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical and electrophysiological diagnosis of CTS

Exclusion criteria

Exclusion Criteria:

  • Cervical radiculopathy
  • Polyneuropathy
  • Brachial plexopathy
  • Thoracic outlet syndrome
  • Previous wrist surgery or steroid injection for CTS
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Focused

    fESWT (0.05-0.29 mJ/mm2, 2000 shocks, 5 Hz)

    Device: Extracorporeal shock wave

  • Active comparator
    Radial

    rESWT (2000shocks, 4 Bar, 5Hz)

    Device: Extracorporeal shock wave

Interventions

  • DeviceExtracorporeal shock wave

    Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (\< 10 ns) and short duration (10 μs). Different studies and clinical experiments have demonstrated the efficacy of shock waves in the treatment of musculoskeletal system such as chronic tendinopathies or hypertrophic pseudoarthrosis.

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What researchers measure

Primary outcomes

  1. Change from baseline of Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) at 24th weeks after treatment

    Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of carpal tunnel syndrome which encompasses two components. eleven questions and eight items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Each question or item ranges from 1 to 5 with a higher score indicating severer symptom or a higher degree of disability. Total score of SSS ranges from 11-55 and FSS from 8-40. The mean of total SSS and FSS divided with each item score were used for further analysis.

    Time frame: Change of the mean of total SSS and FSS from baseline at 24th weeks after treatment

Secondary outcomes

  1. Visual analogue scale (VAS)

    Digital pain severity or paresthesia/dysthesia within 1 week prior to evaluation was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.

    Time frame: Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment

  2. Nerve conduction velocity

    Change from baseline in conduction velocity of median nerve on 2nd, 4th, 8th,12th and 24th weeks after treatment.

    Time frame: Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment

  3. Cross-sectional area (CSA) of the median nerve

    Change from baseline in cross-sectional area of the median nerve on 2nd, 4th, 8th, 12th and 24th weeks after treatment.

    Time frame: Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment

  4. Nerve conduction amplitude

    Change from baseline in conduction amplitude of median nerve on 2nd, 4th, 8th,12th and 24th weeks after treatment.

    Time frame: Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment

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Study locations

1 site
  • Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
    Taipei, Neihu District 886, Taiwan
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References and documents

Publications

  • Wu YT, Ke MJ, Chou YC, Chang CY, Lin CY, Li TY, Shih FM, Chen LC. Effect of radial shock wave therapy for carpal tunnel syndrome: A prospective randomized, double-blind, placebo-controlled trial. J Orthop Res. 2016 Jun;34(6):977-84. doi: 10.1002/jor.23113. Epub 2015 Dec 10. PubMed 26610183 ↗
  • Ke MJ, Chen LC, Chou YC, Li TY, Chu HY, Tsai CK, Wu YT. The dose-dependent efficiency of radial shock wave therapy for patients with carpal tunnel syndrome: a prospective, randomized, single-blind, placebo-controlled trial. Sci Rep. 2016 Dec 2;6:38344. doi: 10.1038/srep38344. PubMed 27910920 ↗
  • Paoloni M, Tavernese E, Cacchio A, D'orazi V, Ioppolo F, Fini M, Santilli V, Mangone M. Extracorporeal shock wave therapy and ultrasound therapy improve pain and function in patients with carpal tunnel syndrome. A randomized controlled trial. Eur J Phys Rehabil Med. 2015 Oct;51(5):521-8. Epub 2015 Feb 20. PubMed 25697763 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03671473
Lead sponsor
Tri-Service General Hospital
Responsible party
Yung-Tsan Wu (Principal Investigator, Tri-Service General Hospital) — Principal investigator
First posted
Sep 14, 2018
Start date
Jan 1, 2019
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Oct 13, 2021

Study contacts

Yung-Tsan Wu, MD
principal investigator · Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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