Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001536853
Ethics application status
Approved
Date submitted
11/10/2021
Date registered
10/11/2021
Date last updated
10/11/2021
Date data sharing statement initially provided
10/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
High volume versus low volume supra scapular nerve block in patients with rotator cuff tears
Scientific title
High volume suprascapular hydrocortisone and local anaesthetic (HCLA) nerve block compared with low volume: a single centre randomised controlled trial in patients with rotator cuff tears
Secondary ID [1] 305691 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator Cuff Tear 323915 0
Condition category
Condition code
Musculoskeletal 321430 321430 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 2 - High volume (intervention) Suprascapular nerve block (SSNB)
10mL total volume injected around the supra scapular nerve (SSN)
9mL 0.5% bupivacaine and 1mL Celestone
Intervention will be administered once only

Intervention will be delivered by trained intervention radiologist or radiology registrar under supervision. The intervention will be an USS guided HCLA injection to the suprascapular nerve. This will be delivered as part of follow up through the outpatient orthopaedic clinic. Follow up will occur 6,12 and 52 weeks after injection.

The same radiologist will perform all injections to ensure adherence to the study protocol. All radiology reports will also be reviewed in clinic

Patients will be provided with comprehensive patient information sheet detailing the study, risks and benefits and contact information.
Intervention code [1] 321925 0
Treatment: Drugs
Comparator / control treatment
Arm 1 - Low volume (control) SSNB
3mL total volume injected around SSN
2mL 0.5% bupivacaine and 1mL Celestone
Intervention will be performed once only
Control group
Active

Outcomes
Primary outcome [1] 329211 0
Constant-Murley Score. This is an assessment of shoulder function, patient reported outcome measures and pain.
Timepoint [1] 329211 0
6 weeks, 12 weeks and 12 months
Secondary outcome [1] 401795 0
VAS score. assesses pain score
Timepoint [1] 401795 0
6 weeks, 12 weeks and 12 months

Eligibility
Key inclusion criteria
• Full thickness or partial thickness symptomatic rotator cuff tear diagnosed on MRI or ultrasound
• Aged above 18 years
• Being managed non-operatively
• Deemed to benefit from SSNB by the treating orthopaedic surgeon
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Inability to provide informed consent
• Person under age of 18
• Allergy or adverse drug reaction to local anaesthetic or corticosteroid
• Patients with adhesive capsulitis, glenohumeral joint osteoarthritis (Samilson-Prieto grade 3 or greater)
• Previous local anaesthetic or corticosteroid within 3 months
• Patients taking disease modifying anti-rheumatic drugs or oral corticosteroids
• Patients with previous surgery on affected shoulder

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation utilising computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power analysis:
Power analysis has been performed under the guidance of a statistician from University of Queensland.
30 participants per group are required
Parameters considered in the power analysis were as follows:

Expected CM score in intervention group following therapy is greater than or equal to 60 with a standard deviation of greater than or equal to 15
This data is based off a recent study that utilised CM score as the primary outcome following high volume SSNB This article included a population similar to the cohort that is proposed in this study

Alpha level 0.05
Power 0.80

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/11/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20719 0
Ipswich Hospital - Ipswich
Recruitment postcode(s) [1] 35523 0
4305 - Ipswich

Funding & Sponsors
Funding source category [1] 309894 0
Self funded/Unfunded
Name [1] 309894 0
Jeremy Day
Country [1] 309894 0
Australia
Primary sponsor type
Hospital
Name
Ipswich Hospital
Address
Ipswich Hospital
Chelmsford Ave
Ipswich
Qld, 4305
Country
Australia
Secondary sponsor category [1] 310923 0
None
Name [1] 310923 0
Address [1] 310923 0
Country [1] 310923 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309618 0
West Moreton Hospital and Health Service Human Research Ethics Committee (HREC)
Ethics committee address [1] 309618 0
West Moreton Hospital and Health Service (HREC)
The Park - Centre for Mental Health, Locked Bag 500 Archerfield QLD 4108
Ethics committee country [1] 309618 0
Australia
Date submitted for ethics approval [1] 309618 0
30/08/2021
Approval date [1] 309618 0
15/10/2021
Ethics approval number [1] 309618 0
HREC/2021/QWMS/77142 (Oct ver 2)

Summary
Brief summary
This study aims to determine if high volume HCLA SSNB injection leads to decreased pain and improved functional outcomes, when compared with low volume injection in patients with rotator cuff tears.

This will be a landmark study for SSNB HCLA injection volumes in the literature. This research will help create a standardised process for the administration of HCLA SSNB injections. At present, there is no protocol or guidelines in place that guide SSNB volumes. Evidence based processes could be created with this research and will have the effect of reliable and reproducible treatment which increase the efficacy and safety of treatment for patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114790 0
Dr Jeremy Day
Address 114790 0
Ipswich Hospital
Orthopaedic Department
Chelmsford Ave
Ipswich, QLD, 4305
Country 114790 0
Australia
Phone 114790 0
+61407117068
Fax 114790 0
Email 114790 0
jeremy.day@health.qld.gov.au
Contact person for public queries
Name 114791 0
Dr Jeremy Day
Address 114791 0
Ipswich Hospital
Orthopaedic Department
Chelmsford Ave
Ipswich, QLD, 4305
Country 114791 0
Australia
Phone 114791 0
+61 738101111
Fax 114791 0
Email 114791 0
jeremy.day@health.qld.gov.au
Contact person for scientific queries
Name 114792 0
Dr Jeremy Day
Address 114792 0
Ipswich Hospital
Orthopaedic Department
Chelmsford Ave
Ipswich, QLD, 4305
Country 114792 0
Australia
Phone 114792 0
+61 738101111
Fax 114792 0
Email 114792 0
jeremy.day@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IN order to protect patient confidentiality due to sensitive health information being collected


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13512Ethical approval  jeremy.day@health.qld.gov.au
13513Informed consent form  jeremy.day@health.qld.gov.au


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.