Condition category
Ear, Nose and Throat
Date applied
13/09/2004
Date assigned
11/10/2004
Last edited
10/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Martin Ptok

ORCID ID

Contact details

Klinik für Phoniatrie und Pädaudiologie
Medizinische Hochschule Hannover - OE 6510
C.-Neuberg-Str.1
Hannover
30625
Germany
+49 (0)511 532 9104
Ptok.Martin@MH-Hannover.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

CVT vs EST in UVCP: RCT

Study hypothesis

Added as of 10/12/2008:
Electrical stimulation therapy is as effective as voice therapy in patients with unilateral recurrent laryngeal nerve paresis.

Ethics approval

The study was approved by the Ethics Committee of the Hannover Medical School.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Vocal cord paresis

Intervention

Conservative voice treatment versus electrostimulation therapy

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2003

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with unilateral vocal cord paresis

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

Added as of 10/12/2008: 90

Participant exclusion criteria

Added as of 10/12/2008:
1. Voice therapy or any other therapy prior to T0
2. Paresis onset less than 2 weeks or more than 6 months prior to therapy
3. Age under 18 years
4. Paresis following resection of the recurrent nerve
5. Pareses due to muscle or joint injuries
6. Hearing loss 40 dB in the 500–3000 Hz range
7. Presence of other conditions possibly interfering with the therapy, such as cognitive deficits or other serious diseases

Recruitment start date

01/01/2003

Recruitment end date

31/12/2003

Locations

Countries of recruitment

Germany

Trial participating centre

Klinik für Phoniatrie und Pädaudiologie
Hannover
30625
Germany

Sponsor information

Organisation

Phoniatry and Paedaudiology Clinic, Hannover Medical School (Germany)

Sponsor details

Martin Ptok
Klinik für Phoniatrie und Pädaudiologie
Medizinische Hochschule Hannover - OE 6510
C.-Neuberg-Str. 1
Hannover
30625
Germany

Sponsor type

Research organisation

Website

http://www.MH-Hannover.de

Funders

Funder type

Other

Funder name

Added as of 10/12/2008:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Hannover Medical School, Clinical Department of Communication Disorders (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 final results in http://www.ncbi.nlm.nih.gov/pubmed/18642381

Publication citations

  1. Final results

    Ptok M, Strack D, Electrical stimulation-supported voice exercises are superior to voice exercise therapy alone in patients with unilateral recurrent laryngeal nerve paresis: results from a prospective, randomized clinical trial., Muscle Nerve, 2008, 38, 2, 1005-1011, doi: 10.1002/mus.21063.

Additional files

Editorial Notes