NCT04302909

Brief Summary

The carpal tunnel syndrome (CTS) is the most common entrapment neuropathy in the general population.The focus extracorporeal shock wave (fEWST) is a non invasive treatment for various diseases. FESWT is new and potential treatment for peripheral nerve entrapment/ peripheral neuropathy . But there is still little known about the effects and long term effects of fESWT in the treatment of CTS.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 24, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

March 2, 2020

Last Update Submit

March 6, 2020

Conditions

Carpal Tunnel Syndrome

Keywords

focused extracorporeal shock wave therapy

Outcome Measures

Primary Outcomes (1)

  • VAS

    Visual Analog Scale: Change from baseline of pain 3th,12th and 24th weeks after treatment.

    baseline, 3th,12th and 24th weeks after treatment

Secondary Outcomes (5)

  • hand grip strength

    baseline, 3th,12th and 24th weeks after treatment

  • distal motor latency of the median nerve

    baseline,12th and 24th weeks after treatment

  • sensory conduction velocity of the median nerve

    baseline, 12th and 24th weeks after treatment

  • SF-36

    baseline, 3th,12th and 24th weeks after treatment

  • Boston Scale

    baseline, 3th,12th and 24th weeks after treatment

Study Arms (2)

Active Comparator

ACTIVE COMPARATOR

fESWT

Other: focused extracorporeal shock wave therapyOther: night splint

Sham Comparator

SHAM COMPARATOR

Sham fESWT

Other: sham focused extracorporeal shock wave therapyOther: night splint

Interventions

focused extracorporeal shock wave therapyOTHER

40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.

Active Comparator
sham focused extracorporeal shock wave therapyOTHER

40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.

Sham Comparator
night splintOTHER

40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.

Active ComparatorSham Comparator

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- mild to moderate CTS verified by nerve conduction velocity

You may not qualify if:

  • metabolic diseases
  • blood clotting problems
  • systemic diseases
  • polyneuropathy
  • chemotherapy during the study
  • corticosteroid therapy
  • use of anticoagulation
  • history of trauma/surgery or nerve lesion of the teated extremity
  • CTS surgery on the affected hand
  • ICD/ pacemaker implantation
  • other therapy for the affected hand during the study
  • acute inflammation or infections
  • severe mental illnesses/psychiatric diseases
  • severe neurological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Physical Medicine, Rehabilitation and Occupational Medicine

Vienna, Austria

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Richard Crevenna, Ao.Univ.-Prof. Dr., MMSc, MBA

    Medical University of Vienna, Department of Physical Medicine, Rehabilitation and Occupational Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Gesslbauer, Dr.

CONTACT

0043 40040043330christina.gesslbauer@meduniwien.ac.at

Christina Gesslbauer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ao.Univ.-Prof. Dr., MMSc. MBA, Head of the Department of Physical Medicine, Rehabilitation and Occupational Medicine

Study Record Dates

First Submitted

March 2, 2020

First Posted

March 10, 2020

Study Start

April 24, 2019

Primary Completion

May 1, 2021

Study Completion

June 1, 2021

Last Updated

March 10, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)