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The Dose Effect of Extracorporeal Shock Wave Therapy in Patients With Carpal Tunnel Syndrome

T

Tri-Service General Hospital

Status

Completed

Conditions

Carpal Tunnel Syndrome

Treatments

Device: ESWT

Study type

Interventional

Funder types

Other

Identifiers

NCT02800187
TSGHIRB: 2-105-05-031

Details and patient eligibility

About

The shock wave is a new and potential intervention for the reinnervation of peripheral nerve. The purpose of this study was to assess the dose effect of extracorporeal shock wave therapy on carpal tunnel syndrome.

Full description

The investigator perform a prospective randomized, single-blinded study to investigate the dose effect of ESWT in patients with carpal tunnel syndrome.

The evaluation was performed pretreatment as well as on the 4th, 8th, 12th, 16th and 24 week after the treatment.

Enrollment

69 patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age between 20-80 year-old.
  2. Typical symptoms and signs of CTS, such as positive Tinel's sign or Phalen's test, numbness/tingling in at least two of the first, second, or third digits, and in whom the diagnosis was confirmed using an electrophysiological study.

Exclusion criteria

  1. Cancer
  2. Coagulopathy
  3. Pregnancy
  4. Inflammation status
  5. Patients who had conditions mimicking CTS, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for CTS.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

69 participants in 3 patient groups

three-sessions of ESWT
Experimental group
Description:
Active three-sessions of ESWT ( once a week for 3 weeks) was given.
Treatment:
Device: ESWT
one-session of ESWT
Active Comparator group
Description:
One-session of ESWTactive ESWT was given.
Treatment:
Device: ESWT
Night splint
Active Comparator group
Description:
The night splint was firmly fixed in a neutral position to immobilize the affected wrist. Patients were ordered to wear the splint while resting at night and at least 8 hours per day during the period of study. Another 3 sessions of sham ESWT was given.
Treatment:
Device: ESWT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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