NCT02801461

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 effect of extracorporeal shock wave therapy on cubital tunnel syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 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

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
4 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

April 25, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

June 10, 2016

Last Update Submit

April 23, 2018

Conditions

Cubital 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 (2)

  • 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 electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks

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

Study Arms (2)

Three-sessions of ESWT

EXPERIMENTAL

ESWT was given once a week for 3 weeks.

Device: extracorporeal shock wave therapy

One-session of ESWT

ACTIVE COMPARATOR

Single ESWT was given.

Device: extracorporeal shock wave therapy

Interventions

extracorporeal shock wave therapyDEVICE

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).

One-session of ESWTThree-sessions of ESWT

Eligibility Criteria

Age20 Years - 80 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 cubital tunnel, such as positive Tinel's sign numbness/tingling in at least 5th 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 cubital tunnel syndrome, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for cubital tunnel syndrome.

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: 26610183BACKGROUND

  • Assmus H, Antoniadis G, Bischoff C, Hoffmann R, Martini AK, Preissler P, Scheglmann K, Schwerdtfeger K, Wessels KD, Wustner-Hofmann M. Cubital tunnel syndrome - a review and management guidelines. Cent Eur Neurosurg. 2011 May;72(2):90-8. doi: 10.1055/s-0031-1271800. Epub 2011 May 4.

    PMID: 21547883BACKGROUND

MeSH Terms

Conditions

Cubital Tunnel Syndrome

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Ulnar NeuropathiesMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesUlnar Nerve Compression SyndromesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
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

October 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 31, 2017

Last Updated

April 25, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will share

Locations

TW(1)