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Trial registered on ANZCTR


Registration number
ACTRN12610000989044
Ethics application status
Approved
Date submitted
14/04/2010
Date registered
16/11/2010
Date last updated
16/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Trial of an injection to reduce shoulder pain for people with Motor Neurone Disease
Scientific title
Suprascapular nerve block for the treatment of shoulder pain in patients with Motor Neurone Disease (MND)
Secondary ID [1] 251619 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Motor Neurone Disease 257166 0
Condition category
Condition code
Neurological 257315 257315 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single injection of 10mls of 0.5% bupivocaine and 40 mg of depomedrol into the suprascapular fossa.
Intervention code [1] 256313 0
Treatment: Drugs
Comparator / control treatment
A placebo injection of 5 mls of normal saline injected subcutaneously.
Control group
Placebo

Outcomes
Primary outcome [1] 258222 0
Proposed outcome measures include a 100 point visual analogue pain scale (VAS).In order to achieve a clinically and statistically significant difference between the two groups, a 10 point difference is required on the VAS.
Timepoint [1] 258222 0
Baseline, 1 week, 6 weeks, 12 weeks.
Primary outcome [2] 258254 0
The shoulder pain and disability index (SPADI) .
Timepoint [2] 258254 0
Baseline, 1 week, 6 weeks, 12 weeks.
Secondary outcome [1] 263879 0
Nil
Timepoint [1] 263879 0
Nil

Eligibility
Key inclusion criteria
All patients with MND and shoulder pain will be considered for the study.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include those patients with an expected life span less than the anticipated follow up period (12 weeks) and/or those already in significant respiratory distress.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be invited to participate in the study and then be followed up by an observer blinded to the intervention type over a period of 12 weeks. Patients will be randomized into those receiving the Suprascapular Nerve Block (SSNB) and usual care and those receiving a placebo injection plus usual care. Numbered sealed opaque envelopes with either treatment or placebo inside will be used and drawn randomly by the person administering the treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using numbered sealed opaque envelopes with either treatment or placebo inside and drawn randomly by the person administering the treatment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256814 0
Charities/Societies/Foundations
Name [1] 256814 0
Foundation Daw Park
Country [1] 256814 0
Australia
Primary sponsor type
Hospital
Name
Repatriation General Hospital
Address
Daws Road
Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 256095 0
None
Name [1] 256095 0
Address [1] 256095 0
Country [1] 256095 0
Other collaborator category [1] 1209 0
University
Name [1] 1209 0
Flinders University
Address [1] 1209 0
2 Sturt Rd
Bedford Park SA 5042
Country [1] 1209 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258837 0
Repatriation General Hospital Ethics Committee
Ethics committee address [1] 258837 0
Daws Road
Daw Park SA 5041
Ethics committee country [1] 258837 0
Australia
Date submitted for ethics approval [1] 258837 0
30/10/2007
Approval date [1] 258837 0
Ethics approval number [1] 258837 0

Summary
Brief summary
Chronic shoulder pain is a common and distressing symptom for a large number of people with motor neurone disease. Treatments which are sometimes used for this problem include physiotherapy, pain killers and injections into the shoulder. Unfortunately, despite these treatments the pain frequently is not well controlled. Recently, a number of rheumatologists around the world have been using an injection to numb the nerve that supplies pain fibres to the shoulder in. This nerve is the suprascapular nerve. The results of studies to date have proven that this form of therapy is safe and works effectively to reduce pain and improve function. However, more information is required to establish this as a useful additional treatment in people with MND.

Researchers at the Repatriation Hospital (Dr Michael Shanahan, Dr Peter Allcroft and Karen Glaetzer) are studying this treatment to see whether it is effective in reducing pain in people with motor neurone disease.
In order to establish whether the treatment is effective in this group, we are performing a trial where we inject around the nerve at a point just above the shoulder blade with a mixture of local anaesthetic and anti-inflammatory steroid and then assess whether this helps to reduce the pain. We then compare the result of the injection with a group of people who do not receive the active injection, but rather a placebo injection of sterile normal saline (salt water). Placebo injections are an accepted practice to ascertain if the improvement in pain is due to the medication used or just the process of injecting into the nerve. We are inviting you to be involved
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31054 0
Address 31054 0
Country 31054 0
Phone 31054 0
Fax 31054 0
Email 31054 0
Contact person for public queries
Name 14301 0
Karen Glaetzer
Address 14301 0
700 Goodwood Road
Daws Park SA 5041
Country 14301 0
Australia
Phone 14301 0
61 8 8275 1732
Fax 14301 0
61 8 82774957
Email 14301 0
[email protected]
Contact person for scientific queries
Name 5229 0
Dr Michael Shanahan
Address 5229 0
Daws Road
Daws Park SA 5041
Country 5229 0
Australia
Phone 5229 0
61 8 8276 9666
Fax 5229 0
Email 5229 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
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Documents added automatically
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