Randomised controlled trial (RCT): Conservative voice treatment (CVT) versus electrostimulation therapy (EST) for unilateral vocal cord paresis (UVCP)
| ISRCTN | ISRCTN17141238 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17141238 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/09/2004
- Registration date
- 11/10/2004
- Last edited
- 10/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Martin Ptok
Scientific
Scientific
Klinik für Phoniatrie und Pädaudiologie
Medizinische Hochschule Hannover - OE 6510
C.-Neuberg-Str.1
Hannover
30625
Germany
| Phone | +49 (0)511 532 9104 |
|---|---|
| Ptok.Martin@MH-Hannover.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | CVT vs EST in UVCP: RCT |
| Study objectives | 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(s) | The study was approved by the Ethics Committee of the Hannover Medical School. |
| Health condition(s) or problem(s) studied | Vocal cord paresis |
| Intervention | Conservative voice treatment versus electrostimulation therapy |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2003 |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | Added as of 10/12/2008: 90 |
| Key inclusion criteria | Patients with unilateral vocal cord paresis |
| Key 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 5003000 Hz range 7. Presence of other conditions possibly interfering with the therapy, such as cognitive deficits or other serious diseases |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 31/12/2003 |
Locations
Countries of recruitment
- Germany
Study participating centre
Klinik für Phoniatrie und Pädaudiologie
Hannover
30625
Germany
30625
Germany
Sponsor information
Phoniatry and Paedaudiology Clinic, Hannover Medical School (Germany)
Research organisation
Research organisation
Martin Ptok
Klinik für Phoniatrie und Pädaudiologie
Medizinische Hochschule Hannover - OE 6510
C.-Neuberg-Str. 1
Hannover
30625
Germany
| Website | http://www.MH-Hannover.de |
|---|---|
"ROR" |
https://ror.org/00f2yqf98 |
Funders
Funder type
Other
Added as of 10/12/2008:
No information available
Hannover Medical School, Clinical Department of Communication Disorders (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | final results | 01/08/2008 | Yes | No |
