Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001645145
Ethics application status
Approved
Date submitted
7/10/2019
Date registered
26/11/2019
Date last updated
6/09/2022
Date data sharing statement initially provided
26/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Genicular Nerve Block for Pain Management in Patients with Knee Osteoarthritis: A Randomised Double-blind Placebo Controlled Trial
Scientific title
Genicular Nerve Block for Pain Management in Patients with Knee Osteoarthritis: A Randomised Control Trial
Secondary ID [1] 299252 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 314641 0
Condition category
Condition code
Musculoskeletal 312982 312982 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Assess for reduction of pain in patients with knee OA when treated with Genicular nerve block compared to placebo. The interventional procedure will be performed by a consultant Radiologist or Rheumatologist who is experienced in administering Genicular nerve blocks under ultrasound guidance.

Intervention
Patient will be positioned supine with a pillow under the popliteal fossa for comfort
Under Ultrasound guidance the superior lateral genicular nerve, superior medial genicular nerve, and inferior medial genicular nerve will by identified by using the corresponding artery as a guide
Under sterile non touch technique with 1ml lidocaine 2% local anaesthetic each nerve will be infiltrated with 5.7mg celestone chronodose (1ml) + 3mL 0.5% bupivacaine at each target site
The study will be conducted at Flinders Medical Centre
The procedure is expected to take approximately 30 minutes
Patients will receive a single Genicular nerve block, and then outcome measures will be recorded at a number of time intervals for 12 weeks following the procedure.
Intervention code [1] 315690 0
Treatment: Other
Intervention code [2] 315854 0
Treatment: Drugs
Comparator / control treatment
Control
Patient will be positioned supine with a pillow under the popliteal fossa for comfort
Under Ultrasound guidance the superior lateral genicular nerve, superior medial genicular nerve, and inferior medial genicular nerve will by identified by using the corresponding artery as a guide
Under sterile non touch technique with 1ml lidocaine 2% local anaesthetic with sham injections (insertion of needle without perineural injection) were performed subcutaneously at each target sites, using 1ml normal saline at 1cm below skin.
Control group
Placebo

Outcomes
Primary outcome [1] 321548 0
Pain perception will be evaluated by single item 0-100 visual analogue scale as well as the Intermittent and Constant Osteoarthritis Pain (ICOAP) Score.
Timepoint [1] 321548 0
Baseline, 2 weeks, 4 weeks (primary timepoint), 8 weeks, 12 weeks
Secondary outcome [1] 375338 0
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Timepoint [1] 375338 0
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Secondary outcome [2] 375339 0
The patient perceived benefit will be determined by a Global Perceived Effect Score on a 7 point Likert scale.
Timepoint [2] 375339 0
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Secondary outcome [3] 375340 0
The illness behaviour questionnaire is a 62 item questionnaire designed to measure inappropriate or maladaptive modes of responding to ones stage of health
Timepoint [3] 375340 0
Baseline, 4 weeks, 12 weeks

Eligibility
Key inclusion criteria
Adults aged 18 yo or older of either sex with knee OA referred for knee replacement surgery
Participants must have knee OA as per ACR classification criteria and chronic knee pain with pain intensity of at least 4/10 on the VAS on most or all days for > 3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with systemic inflammatory joint disease
Allergy to local anaesthetic
Pregnant women
Patients who have undergoing an intra-articular corticosteroid injection to the affected knee/s 3 months prior to enrolment
Patients who are likely to be non-compliant with follow up
Patients who will be unable to provide written informed consent

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)
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
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2020
Actual
9/07/2020
Date of last participant enrolment
Anticipated
Actual
30/10/2021
Date of last data collection
Anticipated
Actual
31/01/2022
Sample size
Target
60
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 14928 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 28200 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 303990 0
Charities/Societies/Foundations
Name [1] 303990 0
Flinders University Flinders Foundation
Country [1] 303990 0
Australia
Primary sponsor type
Hospital
Name
Rheumatology Department, Flinders Medical Centre
Address
Rheumatology Department
Flinders Medical Centre
Flinders Drive
Bedford Park, South Australia 5042
Country
Australia
Secondary sponsor category [1] 304163 0
None
Name [1] 304163 0
Address [1] 304163 0
Country [1] 304163 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304308 0
The Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 304308 0
Ethics committee country [1] 304308 0
Australia
Date submitted for ethics approval [1] 304308 0
07/10/2019
Approval date [1] 304308 0
18/03/2020
Ethics approval number [1] 304308 0
HREC/19/SAC/328

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

Contacts
Principal investigator
Name 96478 0
Prof Michael Shanahan
Address 96478 0
Professor Michael Shanahan
Rheumatology Unit
Southern Adelaide Local Health Network
Flinders Medical Centre, Bedford Park SA 5042
Country 96478 0
Australia
Phone 96478 0
+61 88204 6183
Fax 96478 0
Email 96478 0
[email protected]
Contact person for public queries
Name 96479 0
Suellen Lyne
Address 96479 0
Rheumatology Unit
Southern Adelaide Local Health Network
Flinders Medical Centre, Bedford Park SA 5042
Country 96479 0
Australia
Phone 96479 0
+61 88204 5511
Fax 96479 0
Email 96479 0
[email protected]
Contact person for scientific queries
Name 96480 0
Suellen Lyne
Address 96480 0
Rheumatology Unit
Southern Adelaide Local Health Network
Flinders Medical Centre, Bedford Park SA 5042
Country 96480 0
Australia
Phone 96480 0
+61 88204 5511
Fax 96480 0
Email 96480 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification, the individual patient data underlying the published data will be available
When will data be available (start and end dates)?
From publication date, until no specified end date
Available to whom?
Researches who provide a project proposal of appropriate standard and relevance to the collected data
Available for what types of analyses?
Available for meta-analyses
How or where can data be obtained?
Will be accessible by contacting the appropriate contact person for scientific queries
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5236Informed consent form    Will be available following review by ethics commi... [More Details]
5237Ethical approval    Will be available following review by ethics commi... [More Details]



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.