Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000353190
Ethics application status
Approved
Date submitted
27/02/2019
Date registered
6/03/2019
Date last updated
6/03/2019
Date data sharing statement initially provided
6/03/2019
Date results provided
6/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Trial of Suprascapular Nerve Block for shoulder Pain in Motor Neuron Disease.
Scientific title
A Trial of Suprascapular Nerve Block for shoulder Pain in Motor Neuron Disease.
Secondary ID [1] 297558 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder pain 311785 0
Motor Neuron Disease 311787 0
Condition category
Condition code
Musculoskeletal 310402 310402 0 0
Other muscular and skeletal disorders
Neurological 310403 310403 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Suprascapular nerve block 20 mg depomedrol plus 10 mls of 0.5% bupivacaine as a single one off injection intramuscularly
Intervention code [1] 313788 0
Treatment: Other
Intervention code [2] 313820 0
Treatment: Drugs
Comparator / control treatment
Historic control based on earlier studies;

EM Shanahan, MJ Ahern, B Bresnihan, MD Smith, O FitzGerald. Suprascapular nerve block using Bupivacaine and Methylprednisolone in chronic shoulder pain. Annals of the Rheumatic Diseases 2003. 62 (5) 400-406

The data for the historic control is published in the above paper and was gathered as part of a research study performed at the Repatriation General Hospital, Daw Park SA. The Data was gathered between the years 2000 and 2003.
Control group
Historical

Outcomes
Primary outcome [1] 319273 0
Pain measured using the pain scale of the SPADI (shoulder pain and disability questionnaire).
Timepoint [1] 319273 0
Baseline and 1, 6 and 12 weeks post enrolment
Secondary outcome [1] 367533 0
Patient satisfaction using a 10 point visual analogue scale from 0 (very unsatisfied) to 10 (most satisfied).
Timepoint [1] 367533 0
12 weeks post intervention

Eligibility
Key inclusion criteria
Symptomatic shoulder pain in patents with motor neuron disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to corticosteroid or local anaesthetic

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis was undertaken using SPSS V24 (IBM Statistics, Armonk, NY USA) and STATA V15 (StataCorp, College Station, TX, USA). Frequencies and proportions of those with shoulder pain were determined for both the MND and community-based comparison groups in the first part of the study.

For the second part of the study, means and proportions were determined where appropriate. ANOVA was used to determine if significant differences existed overall in SPADI scores and then a Bonferroni correction was used to determine the significant differences in SPADI scores at each time point. As repeated measures were taken over time, multilevel repeated models using the xtmixed command in STATA were used to assess the associations between SPADI pain scores and other covariates. This type of regression model allows for the correlations of observations within subjects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/05/2008
Date of last participant enrolment
Anticipated
Actual
15/07/2018
Date of last data collection
Anticipated
Actual
28/09/2018
Sample size
Target
38
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 13275 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 25840 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 302110 0
Hospital
Name [1] 302110 0
Repatriation General Hospital
Country [1] 302110 0
Australia
Funding source category [2] 302137 0
Hospital
Name [2] 302137 0
Flinders Medical Centre
Country [2] 302137 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Flinders Drive
Bedford Park
SA 5042
Country
Australia
Secondary sponsor category [1] 301942 0
None
Name [1] 301942 0
Address [1] 301942 0
Country [1] 301942 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302789 0
Southern Adelaide Local Health Network, Adelaide, South Australia ethics committee. (.previously RGH ethic committee)
Ethics committee address [1] 302789 0
Ethics committee country [1] 302789 0
Australia
Date submitted for ethics approval [1] 302789 0
18/07/2007
Approval date [1] 302789 0
19/12/2007
Ethics approval number [1] 302789 0
Approval number RGH 46/07)

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

Contacts
Principal investigator
Name 91410 0
Prof Michael Shanahan
Address 91410 0
Rheumatology Department Flinders Medical Centre Flinders Drive Bedford Park South Australia 5042
Country 91410 0
Australia
Phone 91410 0
+61 8 8204 6429
Fax 91410 0
61 8 8204 4150
Email 91410 0
[email protected]
Contact person for public queries
Name 91411 0
Michael Shanahan
Address 91411 0
Rheumatology Department Flinders Medical Centre Flinders Drive Bedford Park South Australia 5042
Country 91411 0
Australia
Phone 91411 0
+61 8 8204 6429
Fax 91411 0
61 8 8204 4150
Email 91411 0
[email protected]
Contact person for scientific queries
Name 91412 0
Michael Shanahan
Address 91412 0
Rheumatology Department Flinders Medical Centre Flinders Drive Bedford Park South Australia 5042
Country 91412 0
Australia
Phone 91412 0
+61 8 8204 6429
Fax 91412 0
61 8 8204 4150
Email 91412 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers with appropriately sound research projects

Conditions for requesting access:
• -

What individual participant data might be shared?
• SPADI scores, patient satisfaction scores

What types of analyses could be done with individual participant data?
• Meta-analysis

When can requests for individual participant data be made (start and end dates)?
From:
1/3/19

To:
31/12/20

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approval by principal investigator

Are there extra considerations when requesting access to individual participant data?
No


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.