NCT02800187

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

1.5 years

First QC Date

June 10, 2016

Last Update Submit

October 10, 2017

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of pain on 4th, 8th, 12th, 16th and 24th weeks after treatment.

    Visual analog scale (VAS)

    Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment

Secondary Outcomes (3)

  • Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks

    Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment

  • Change from baseline of cross-sectional area in median nerve on 4th, 8th, 12th, 16th and 24th weeks

    Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment

  • Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks

    Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment

Study Arms (3)

three-sessions of ESWT

EXPERIMENTAL

Active three-sessions of ESWT ( once a week for 3 weeks) was given.

Device: ESWT

one-session of ESWT

ACTIVE COMPARATOR

One-session of ESWTactive ESWT was given.

Device: ESWT

Night splint

ACTIVE COMPARATOR

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.

Device: ESWT

Interventions

ESWTDEVICE

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).

Night splintone-session of ESWTthree-sessions of ESWT

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 20-80 year-old.
  • 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.

You may not qualify if:

  • Cancer
  • Coagulopathy
  • Pregnancy
  • Inflammation status
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Taipei, Neihu District, 886, Taiwan

Location

Related Publications (2)

  • 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.

    PMID: 26610183RESULT

  • Seok H, Kim SH. The effectiveness of extracorporeal shock wave therapy vs. local steroid injection for management of carpal tunnel syndrome: a randomized controlled trial. Am J Phys Med Rehabil. 2013 Apr;92(4):327-34. doi: 10.1097/PHM.0b013e31826edc7b.

    PMID: 23044704RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician of Physical medicine and rehabilitation

Study Record Dates

First Submitted

June 10, 2016

First Posted

June 15, 2016

Study Start

April 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

October 11, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will share

Locations

TW(1)