Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000671268
Ethics application status
Not yet submitted
Date submitted
31/07/2009
Date registered
6/08/2009
Date last updated
6/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dysphagia in Inflammatory Muscle Diseases: Answering the Questions Who, Where, Why and What to Do?
Scientific title
Dysphagia in Inflammatory Muscle Diseases: Answering the Questions Who, Where, Why and What to Do?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Swallowing (dysphagia) problems in patients with Inflammatory muscle diseases (Inclusion body myositis, dermatomyositis and polymyositis 243430 0
Condition category
Condition code
Musculoskeletal 239736 239736 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
using videofluoroscopy and manometry to investigate the mechanisms behind swallowing problems reported by patients with inflammatory muscle diseases
Videofluoroscopy is a procedure where patients ingest radioopaque barium sulphaate mixed with small amounts of food/fluids. The procedure is x-rayed using a fluoroscope and recorded to allow frame-by-frame analysis of the swallowing dynamic. The procedure exposes patients to small amounts of ionising radiation (calculated as 0.2 milliseiverts).
The Videofluoroscopy will be performed simulataneously with a manometric examination of the swallow.
Participants have a purpose built manometric catheter (outside diameter 2.0 mm) inserted via the nares and positioned in the upper oesophageal sphincter. Recordings of upper oesophageal sphincter, oesophageal and pharyngeal pressures will be recorded.
TOTAL time for both procedures =30 minutes approx.
Intervention code [1] 237056 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240488 0
determination of mechanism causing dysphagia in patients with inflammatory muscle diseases

Patients with inflammatory muscle diseases demonstrate food boluses pooling in the pharynx: this is often treated via cricopharyngeal myotomy. There are 3 possible causes of this pooling: 1. poor pharyngeal muscle contraction 2. failure of the tonically contracted upper oesophageal sphincter to relax 3. impaired hyolaryngeal excursion.
Use of manometry in combination with videofluoroscopy will allow identification of which of the three mechanisms is impaired in the inflammatory muscle disease population.
Timepoint [1] 240488 0
The participants are required to undergo assessment one time only. The time estimated that the study will take to complete is 6-12 months
Secondary outcome [1] 257038 0
N/A
Timepoint [1] 257038 0
N/A

Eligibility
Key inclusion criteria
diagnosed with inflammatory muscle diseases
able to provide informed consent
no surgical interventions to head/neck
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
unable to provide consent
surgical intervention to head/neck
any other neurological condition

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237430 0
Hospital
Name [1] 237430 0
Sir Charles Gairdner Hospital
Country [1] 237430 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
Nedlands 6009
West Australia
Country
Australia
Secondary sponsor category [1] 236922 0
None
Name [1] 236922 0
Address [1] 236922 0
Country [1] 236922 0
Other collaborator category [1] 803 0
Other Collaborative groups
Name [1] 803 0
Australian Neuromuscular Research Institute
Address [1] 803 0
Hospital Avenue
Nedlands 6009
West Australia
Country [1] 803 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239560 0
Sir Charles Gairdner Hospital
Ethics committee address [1] 239560 0
Hospital Avenue
Nedlands 6009
West Australia
Ethics committee country [1] 239560 0
Australia
Date submitted for ethics approval [1] 239560 0
01/08/2009
Approval date [1] 239560 0
Ethics approval number [1] 239560 0
2009-060

Summary
Brief summary
This study aims to better investigate the underlying problem behind the swallowing difficulties (dysphagia) experienced by many people diagnosed with inflammatory muscle disorders (Inclusion Body Myositis, Dermatomyositis and Polymyositis)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29998 0
Address 29998 0
Country 29998 0
Phone 29998 0
Fax 29998 0
Email 29998 0
Contact person for public queries
Name 13245 0
Dr. Claire Langdon
Address 13245 0
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
West Australia
Country 13245 0
Australia
Phone 13245 0
+61-8-9346-2044
Fax 13245 0
+61-8-9346-4103
Email 13245 0
[email protected]
Contact person for scientific queries
Name 4173 0
Dr. Claire Langdon
Address 4173 0
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
West Australia
Country 4173 0
Australia
Phone 4173 0
+61-8-9346-2044
Fax 4173 0
+61-8-9346-4103
Email 4173 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.