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Trial registered on ANZCTR


Registration number
ACTRN12623000360617
Ethics application status
Approved
Date submitted
10/02/2023
Date registered
12/04/2023
Date last updated
12/05/2023
Date data sharing statement initially provided
12/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Focused Ultrasound on Pain in Moderate-to-Severe Knee Osteoarthritis
Scientific title
A Clinical Pilot, Prospective, Participant and Observer-Blinded, Sham-Controlled, Randomised, Dose-Response Study Investigating Focused Ultrasound for Temporary Pain Relief in Moderate-to-Severe Knee Osteoarthritis
Secondary ID [1] 308799 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 328752 0
Condition category
Condition code
Musculoskeletal 325755 325755 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Focused ultrasound (focused ultrasound energy) will be transcutaneously applied to the saphenous nerve under imaging ultrasound guidance in participants with moderate-to-severe knee osteoarthritis. The procedure will occur only once in an outpatient clinic and be completed by a sports medicine physician. It will take approximately 10-15 minutes.

This is a dose-response study, where participants will be randomised to one of four cohorts of four subjects each (9W, 18W, 27W) and the degree and duration of pain relief assessed on a per-cohort basis. Each participant within a cohort will receive the same dose.
Intervention code [1] 325250 0
Treatment: Devices
Comparator / control treatment
One cohort will receive sham treatment (an identical procedure, but with 0W).
Control group
Placebo

Outcomes
Primary outcome [1] 333601 0
Change in pain intensity, as measured by percentage change in numerical rating scale (NRS) with the chosen activity on Days 0, 1, 3, 5 and 7 post-procedure.
Timepoint [1] 333601 0
Days 0, 1, 3, 5 and 7 post-procedure
Primary outcome [2] 333602 0
Change in medication consumption, as measured by percentage change in medication dosage on Days 1, 3, 5 and 7 post-procedure (patient report via study-specific questionnaire)
Timepoint [2] 333602 0
Days 1, 3, 5 and 7 post-procedure
Secondary outcome [1] 417713 0
Total frequency and severity of adverse events in accordance with the Common Terminology Criteria for Adverse Events (CTCAE 5.0)

Potential adverse events include:
- Temporary altered sensation
- Temporary muscle tenderness
- Temporary skin irritation/redness
Timepoint [1] 417713 0
Days 0, 1, 3 and 7 post-procedure

Eligibility
Key inclusion criteria
1. Adults >= 18 years of age with Medicare coverage.
2. Participants with medial knee osteoarthritis, where:
a) Knee osteoarthritis is defined according to American College of Rheumatology criteria (knee pain, aching or stiffness on most of the past 30 days and evidence on radiograph of knee osteoarthritis).
b) Participants have evidence of disease in the medial compartment on a radiograph, where evidence of disease in the medial compartment in radiographs is defined as at least grade 2 on the Kellgren and Lawrence system.
3) Knee pain of at least 5 out of 10 when performing one of two movements that elicit the worst pain: standing from a seated position and a slow squat (90 degrees).
4) Knee pain is reported in the medial knee as documented on the knee pain map.
5) A diagnostic nerve block of the infrapatellar branch of the saphenous nerve results in a >=50% reduction in the NRS pain assessment score in knee pain when performing the activity that elicits the worst pain: standing from a seated position or a slow squat (90 degrees).
6) Stable use of prescription and over-the-counter pain medication for >=1 month.
7) Ambulatory without assistive devices.
8) An ability to read and speak English fluently.
9) Willing and able to sign a written informed consent document.
10) Willing and able to comply with study instructions and commit to all follow-up requirements for the duration of the study.
11) In good general health and free of any systemic disease or physical condition that might impair evaluation or which in the Investigator’s opinion, exposes the participant to an unacceptable risk by study participation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Planned knee replacement within the next 3 months in the knee to be treated.
2. Viscosupplementation, intra-articular steroid injection, acupuncture or percutaneous electrical nerve stimulation within the previous 3 months in the knee to be treated.
3. Previous radiofrequency ablation or cryotherapy in the knee to be treated.
4. Prior surgery in the treatment area that may alter the anatomy of the saphenous nerve or result in scar tissue in the skin or soft tissue overlying the treatment area.
5. Prior knee replacement surgery or open knee surgery in the knee to be treated.
6. Prior trauma or fractures within the previous 12 months in the knee to be treated.
7. Open and/or infected wound in the treatment area.
8. Participant reports the majority of knee pain to be outside of the medial aspect of the knee.
9. Use of opioids within the previous 3 months or previous history of opioid abuse.
10. Body Mass Index >= 39 kg/m2
11. Saphenous nerve is:
a) Not visible on ultrasound, OR
b) Not accessible with the device, OR
c) Larger in cross-sectional area compared to the focused ultrasound focal region.
12. Concomitant inflammatory disease or other condition which affects joints (e.g. rheumatoid arthritis, metabolic bone disease, gout, active infection).
13. Concomitant skin conditions at the treatment site that in the Investigator’s opinion would adversely affect treatment or outcomes.
14. Part of another trial testing other investigational devices for knee pain or analgesic agents.
15. Life expectancy of <12 months.
16. Pacemakers or other life-sustaining devices.
17. Current or previous artery aneurysm or stent in the intended treatment region.
18. Any chronic medical condition or chronic medication use that in the Investigator’s opinion would affect study participation or safety.
19. Any other reason in the opinion of the Investigator that the participant may not be a suitable candidate for study participation (i.e. history of non-compliance, drug dependency, etc.).
20. Employees, relatives or students with ties to any of the investigators or sponsor.
21. Femoral artery plaque adjacent to the target nerve region on imaging ultrasound.

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)
Central randomisation using the National Cancer Institute Clinical Trial Randomisation Tool
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Asymptotic maximal procedure using the National Cancer Institute Clinical Trial Randomisation Tool
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will be utilised for study outcomes. Statistical significance will not be assessed due to the small sample size of each cohort.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/05/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23857 0
Sportsmed Biologic - Box Hill
Recruitment postcode(s) [1] 39316 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 313015 0
Commercial sector/Industry
Name [1] 313015 0
Pegasus Neurotechnology
Country [1] 313015 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Pegasus Neurotechnology
Address
470 St Kilda Rd
Melbourne, VIC 3004
Country
Australia
Secondary sponsor category [1] 314704 0
None
Name [1] 314704 0
None
Address [1] 314704 0
None
Country [1] 314704 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312278 0
St Vincent's Hospital Melbourne HREC
Ethics committee address [1] 312278 0
Ethics committee country [1] 312278 0
Australia
Date submitted for ethics approval [1] 312278 0
14/02/2023
Approval date [1] 312278 0
09/05/2023
Ethics approval number [1] 312278 0

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

Contacts
Principal investigator
Name 124086 0
Dr Philip Bloom
Address 124086 0
Sportsmed Biologic
1G/116 -118 Thames St, Box Hill VIC 3128
Country 124086 0
Australia
Phone 124086 0
+61 1300 858 860
Fax 124086 0
Email 124086 0
philipbloom@me.com
Contact person for public queries
Name 124087 0
Giang Nguyen
Address 124087 0
Pegasus Neurotechnology
470 St Kilda Rd
Melbourne, VIC 3004
Country 124087 0
Australia
Phone 124087 0
+61 3 9016 0009
Fax 124087 0
Email 124087 0
pegasusneurotechnology@gmail.com
Contact person for scientific queries
Name 124088 0
Giang Nguyen
Address 124088 0
Pegasus Neurotechnology
470 St Kilda Rd
Melbourne, VIC 3004
Country 124088 0
Australia
Phone 124088 0
+61 3 9016 0009
Fax 124088 0
Email 124088 0
pegasusneurotechnology@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is an early assessment of the safety and efficacy of a novel product for which sharing of data would not be useful to existing commercial products or pain management approaches.


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.