Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000621213
Ethics application status
Approved
Date submitted
22/07/2009
Date registered
27/07/2009
Date last updated
11/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does Nerve Block Reduce Shoulder Pain Following Stroke?
Scientific title
Does Suprascapular Nerve Block Reduce Shoulder Pain Following Stroke: A single-blind randomised controlled trial with measured outcome assessment.
Secondary ID [1] 295510 0
Nil known
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 237261 0
Condition category
Condition code
Stroke 239584 239584 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive injection into the arm of suprascapular nerve blocking (using depo-medrol 40mg and 0.5% bupivivocaine hydrochloride).
Intervention code [1] 236946 0
Treatment: Drugs
Comparator / control treatment
The control group will receive 5ml normal saline infiltrated subcutaneously after the 2ml subcutaneous 1% lidocaine infiltration.
Control group
Placebo

Outcomes
Primary outcome [1] 238378 0
Visual Analogue Scale (VAS) to assess for shoulder pain.
Timepoint [1] 238378 0
Baseline, 1, 4, 12 weeks following injection.
Change in Visual Analogue Scale of pain in comparison to baseline
Secondary outcome [1] 244834 0
Croft Disability Questionnarie
Timepoint [1] 244834 0
Baseline 1, 4, 12 weeks following injection.
Secondary outcome [2] 244835 0
Modified Rankin Scale - Functional disability associated with shoulder pain
Timepoint [2] 244835 0
Baseline, 1, 4, 12 weeks following injection.
Secondary outcome [3] 244912 0
Euroquol Questionnaire - Quality of life
Timepoint [3] 244912 0
Baseline, 1, 4 & 12 weeks following injection.

Eligibility
Key inclusion criteria
Inclusion criteria will be all willing patients aged over 18 years and able to give consent with a diagnosis of acute stroke with the previous 12 months and onset of hemiplegic shoulder pain post stroke with a visual analogue scale score of >30mm (100mm scale)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive deficit that preclude patients
from reliably using subjective outcome measures scales - Mini-Mental State Examination (MMSE) < 23.

Language deficits (inability to follow 2-
stage command) or limited English language that preclude patients from reliably using subjective outcome measures scales

Allergy to proposed injection agents (depo-medrol 40mg and 0.5% bupivocaine hydrocholoride)

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)
Following consent and baseline measures particpants will be randomized to receive suprascapular nerve block or placebo injection. Allocation will be managed by a pharmacist external to the project.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation - computer generated by a software program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/06/2009
Actual
11/06/2009
Date of last participant enrolment
Anticipated
Actual
9/02/2010
Date of last data collection
Anticipated
Actual
24/07/2012
Sample size
Target
66
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237373 0
University
Name [1] 237373 0
Flinders University
Country [1] 237373 0
Australia
Primary sponsor type
Individual
Name
Maria Crotty
Address
Repartriation General Hospital
Daws Road, Daw Park, SA, 5041
Country
Australia
Secondary sponsor category [1] 236868 0
None
Name [1] 236868 0
Address [1] 236868 0
Country [1] 236868 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239450 0
Queen Elizabeth Hospital Research and Ethics Committee
Ethics committee address [1] 239450 0
Ethics committee country [1] 239450 0
Australia
Date submitted for ethics approval [1] 239450 0
23/03/2009
Approval date [1] 239450 0
21/04/2009
Ethics approval number [1] 239450 0
2009031
Ethics committee name [2] 239451 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [2] 239451 0
Ethics committee country [2] 239451 0
Australia
Date submitted for ethics approval [2] 239451 0
19/03/2009
Approval date [2] 239451 0
07/05/2009
Ethics approval number [2] 239451 0
090325
Ethics committee name [3] 239452 0
Repatriation General Hospital Human Research and Ethics Committee
Ethics committee address [3] 239452 0
Ethics committee country [3] 239452 0
Australia
Date submitted for ethics approval [3] 239452 0
18/03/2009
Approval date [3] 239452 0
27/04/2009
Ethics approval number [3] 239452 0
9/09/
Ethics committee name [4] 239459 0
Flinders Clinical Research Ethics Committee
Ethics committee address [4] 239459 0
Ethics committee country [4] 239459 0
Australia
Date submitted for ethics approval [4] 239459 0
03/03/2009
Approval date [4] 239459 0
07/04/2009
Ethics approval number [4] 239459 0
61/09

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29904 0
Prof Maria Crotty
Address 29904 0
Department of Rehabilitation, Aged & Extended Care, Repatriation General Hospital, Daws Road, Daw Park SA 5041
Country 29904 0
Australia
Phone 29904 0
+61 8 8275 1019
Fax 29904 0
Email 29904 0
[email protected]
Contact person for public queries
Name 13151 0
Dr Zoe Adey Allen
Address 13151 0
Department of Rehabilitation & Aged Care
Repatriation General Hospital
Daws Road, Daw Park, SA 5041
Country 13151 0
Australia
Phone 13151 0
+61 8 8276 9666
Fax 13151 0
+61 8 8275 1130
Email 13151 0
[email protected]
Contact person for scientific queries
Name 4079 0
Dr Zoe Adey Allen
Address 4079 0
Department of Rehabilitation & Aged Care
Repatriation General Hospital
Daws Road, Daw Park, SA 5041
Country 4079 0
Australia
Phone 4079 0
+61 8 8276 9666
Fax 4079 0
+61 8 8275 1130
Email 4079 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.