ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

N/A

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Condition category

Condition code

Stroke

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]

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]

Visual Analogue Scale (VAS) to assess for shoulder pain.

Timepoint [1]

Baseline, 1, 4, 12 weeks following injection.
Change in Visual Analogue Scale of pain in comparison to baseline

Secondary outcome [1]

Croft Disability Questionnarie

Timepoint [1]

Baseline 1, 4, 12 weeks following injection.

Secondary outcome [2]

Modified Rankin Scale - Functional disability associated with shoulder pain

Timepoint [2]

Baseline, 1, 4, 12 weeks following injection.

Secondary outcome [3]

Euroquol Questionnaire - Quality of life

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Flinders University

Address [1]

Flinders Drive, Bedford Park, SA 5043

Country [1]

Australia

Primary sponsor type

Individual

Name

Maria Crotty

Address

Repartriation General Hospital
Daws Road, Daw Park, SA, 5041

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Queen Elizabeth Hospital Research and Ethics Committee

Ethics committee address [1]

28 Woodville Road,
Woodville South, SA, 5011

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/03/2009

Approval date [1]

21/04/2009

Ethics approval number [1]

2009031

Ethics committee name [2]

Royal Adelaide Hospital Research Ethics Committee

Ethics committee address [2]

North Terrace,
Adelaide, SA, 5000

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

19/03/2009

Approval date [2]

07/05/2009

Ethics approval number [2]

090325

Ethics committee name [3]

Repatriation General Hospital Human Research and Ethics Committee

Ethics committee address [3]

Daws Road,
Daw Park, SA, 5941

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

18/03/2009

Approval date [3]

27/04/2009

Ethics approval number [3]

9/09/

Ethics committee name [4]

Flinders Clinical Research Ethics Committee

Ethics committee address [4]

Flinders Medical Centre 
Bedford Park, SA, 5042

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

03/03/2009

Approval date [4]

07/04/2009

Ethics approval number [4]

61/09

Summary

Brief summary

Shoulder pain is a common and debilitating symptom for a large number of people following a stroke.  The cause of shoulder pain is usually related to several factors, including trauma, inflammation and positioning.  In cases when shoulder pain is unable to be prevented, current treatment options include arm supports, physiotherapy techniques, and simple analgesic medication.

It is commonly observed that shoulder pain persists or is inadequately controlled by these interventions.  This research aims to study the effect of an injection that numbs the nerve (Suprascapular Nerve) that supplies pain fibres to the shoulder.  The technique has previously been proven safe and effective in the treatment of shoulder pain associated with rheumatoid arthritis and degenerative shoulder conditions.

Trial website

Trial related presentations / publications

Adey-Wakeling Z, Crotty M, Liu E, Shanahan M. Suprascapular Nerve Block for Hemiplegic Shoulder Pain Post Stroke: Subgroup Analysis of Pain Response . Jacobs Journal of Physical Medicine Rehabilitation 2015;1(2):009

22/08/2013 
Adey-Wakeling Z, Crotty M, Shanahan EM. Suprascapular nerve block for shoulder pain in the first year after stroke: A randomized controlled trial.  First published online: 22 August 2013. DOI: 10.1161/STROKEHA.113.00247

Z. Adey-Wakeling, M. Crotty, EM. Shanahan.   Suprascapular nerve block for shoulder pain in the first year after stroke: a randomised controlled trial ACR, San Diego, Oct 2013

Adey-Wakeling Z, Crotty M, Shanahan EM. Suprascapular nerve block for shoulder pain in the first year after stroke. Australasian Faculty of Rehabilitation Medicine Annual Scientific Meeting, held from 17-20 September 2013 in Sydney, Australia

31/07/2013 
Adey-Wakeling Z, Crotty M, Shanahan EM. Suprascapular nerve block for shoulder pain in the first year after stroke. 24st Annual Scientific Meeting of Stroke Society of Australia, held from 31 July-2 August 2013 in Darwin, Australia

Public notes

Contacts

Principal investigator

Name

Prof Maria Crotty

Address

Department of Rehabilitation, Aged & Extended Care, Repatriation General Hospital, Daws Road, Daw Park SA 5041

Country

Australia

Phone

+61 8 8275 1019

Fax

maria.crotty@flinders.edu.au

Contact person for public queries

Name

Dr Zoe Adey Allen

Address

Department of Rehabilitation & Aged Care
Repatriation General Hospital
Daws Road, Daw Park, SA 5041

Country

Australia

Phone

+61 8 8276 9666

Fax

+61 8 8275 1130

zoe.allen@health.sa.gov.au

Contact person for scientific queries

Name

Dr Zoe Adey Allen

Address

Department of Rehabilitation & Aged Care
Repatriation General Hospital
Daws Road, Daw Park, SA 5041

Country

Australia

Phone

+61 8 8276 9666

Fax

+61 8 8275 1130

zoe.allen@health.sa.gov.au

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

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Documents added automatically

No additional documents have been identified.

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