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Trial registered on ANZCTR


Registration number
ACTRN12620000726954
Ethics application status
Approved
Date submitted
4/05/2020
Date registered
7/07/2020
Date last updated
7/07/2020
Date data sharing statement initially provided
7/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Efficacy of Focused Shockwave Therapy on Knee Osteoarthritis related Bone Marrow Oedema.
Scientific title
Open-label Trial to Investigate The Efficacy and Safety of Focused Extracorporeal Shockwave Therapy on Knee Osteoarthritis related Bone Marrow Oedema.
Secondary ID [1] 300648 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 316430 0
Condition category
Condition code
Musculoskeletal 314690 314690 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Focused-Extracorporeal shockwave therapy (ESWT) will be delivered using ORTHOSPEC COMPACT system by Medispec Int. (Gaithersburg, MD 20877, USA) with an electrohydraulic method of shockwaves generation. The intervention will be delivered by an experienced physiotherapist, accredited in ESWT clinical application. The determined lowest optimal dose from an ongoing pilot study will be administered for all participants.
The shockwave dosage range used in the ongoing pilot study is as follows: the minimum dose is weekly sessions of 1500 shocks for 4 weeks, the maximum dose is weekly sessions of 3000 shocks for 6 weeks. The Energy Flux Density (EFD) will vary for each participant and will be set on the first treatment session to the lowest level (level 1 out of 4), 15 KV, 200 bar, equivalent to 0.18 mJ/mm2) and will be progressed gradually over the treatment sessions according to the participant pain level not exceeding 4/10 on VAS as monitored regularly by the treating physiotherapist. That could be reduced down subsequently.
The determined lowest optimal dose will be based on changes in pressure pain threshold measured in kPa.
Intervention code [1] 316979 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323017 0
Pressure Pain Threshold (PPT) will be assessed using an electronic digital pressure algometer (Somedic AB, Sweden)
Timepoint [1] 323017 0
Baseline, end of treatment and 3 months following the last treatment session (primary timepoint)
Primary outcome [2] 323028 0
The WOMAC questionnaire for measuring subjective pain, stiffness and dysfunction
Timepoint [2] 323028 0
Baseline, end of treatment and 3 months following the last treatment session (primary timepoint)
Secondary outcome [1] 380536 0
Semi-quantitative MRI assessment of bone marrow lesion (BML) using the Whole Organ Magnetic Imaging Score (WORMS)
Timepoint [1] 380536 0
Baseline and following 3 months from last treatment session.
Secondary outcome [2] 380538 0
Inflammatory biomarkers: Interleukin 1 (IL-1), Interleukin 6 (IL-6), C-reactive protein (CRP) and tumour necrosis factor (TNF-a)).
Following blood collection, the sample will be centrifuged and the serum will be stored at -80°C until analyzed. Serum biomarker levels will be measured following the procedures recommended by the manufacturer using sandwich enzyme-linked immunosorbent assays kits.
Timepoint [2] 380538 0
Baseline and 3 months following the last treatment session
Secondary outcome [3] 382582 0
Aggregated Locomotor Function (ALF) test
Timepoint [3] 382582 0
at Baseline, end of treatment and 3 months following the last treatment session,
Secondary outcome [4] 382583 0
DXA for the assessment of subchondral bone mineral density based on the semi-standardized protocol
Timepoint [4] 382583 0
Baseline and following 3 months from last treatment session.
Secondary outcome [5] 383519 0
Collagen type II biomarkers: Serum cartilage oligomeric matrix protein (sCOMP), Serum hyaluronan (sHA), serum matrix metalloproteinases (MMP-1 and MMP-3).
Following blood collection, the sample will be centrifuged and the serum will be stored at -80°C until analyzed. Serum biomarker levels will be measured following the procedures recommended by the manufacturer using assays kits.
Timepoint [5] 383519 0
Baseline and 3 months following the last treatment session

Eligibility
Key inclusion criteria
Individuals with medically diagnosed painful knee osteoarthritis (OA) (VAS =>4 out 10) will be screened for suitability by a consultant rheumatologist according to the American College of Rheumatology (ACR) clinical classification criteria for knee OA.
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of neurological disorders affecting sensory, motor or cognitive function; recent lower limb injury or surgery; previous treatment with ESWT or intra-articular injection into the affected knee during the last 6 months.

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Within-subjects changes will be statistically analysed using repeated measures analysis of variance (ANOVA) (clinical measures) on an intention-to-treat basis with significance set at 0.05. Paired samples t-tests will be used to evaluate changes in measures evaluated at baseline and final follow-up.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 305072 0
University
Name [1] 305072 0
Curtin University
Address [1] 305072 0
Kent St, Bentley WA 6102
Country [1] 305072 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 305440 0
None
Name [1] 305440 0
Address [1] 305440 0
Country [1] 305440 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305461 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 305461 0
Kent St, Bentley WA 6102
Ethics committee country [1] 305461 0
Australia
Date submitted for ethics approval [1] 305461 0
05/05/2020
Approval date [1] 305461 0
18/06/2020
Ethics approval number [1] 305461 0
HRE2020-0334

Summary
Brief summary
BACKGROUND:
Osteoarthritis (OA) is the most prevalent form of arthritis causing increasing pain, disability, reduced quality of life and economic burden worldwide. Its incidence is directly related to age with about 50% of the affected people aged over 65. Treatment for the disease is largely symptomatic with no established disease modifying interventions. Extracorporeal shock wave therapy (ESWT) is a physical treatment modality that has been shown to be effective in treating non-union of fractures and resolving a range of conditions associated with tendinopathy. Research in animal models suggests that ESWT may be effective in reducing the inflammatory and degenerative processes associated with osteoarthritis.
AIMS:
To evaluate the optimum lowest effective Focused-ESWT dose on knee OA related BML for efficacy and safety indications and to inform the design of a future randomised controlled trial (RCT).
HYPOTHESIS:
The participants who will receive the determined optimum Focused-ESWT dose will exhibit both clinical and biological improvements over the course of the study period.
METHODS:
Focused-ESWT will be delivered using the determined lowest optimal dose from a previous pilot study. The optimal dose will be determined based on the lowest dosage that demonstrates significant improvements in clinical and pathoanatmical changes based on imaging and biomarkers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100458 0
Mr Hani Alabbad
Address 100458 0
School of Physiotherapy and Exercise Science, Curtin University, GPO Box U1987, Perth, WA 6845.
Country 100458 0
Australia
Phone 100458 0
+61 452588321
Fax 100458 0
Email 100458 0
hani.alabbad@postgrad.curtin.edu.au
Contact person for public queries
Name 100459 0
Prof Tony Wright
Address 100459 0
School of Physiotherapy and Exercise Science, Curtin University, GPO Box U1987, Perth, WA 6845.
Country 100459 0
Australia
Phone 100459 0
+61 401 103 476
Fax 100459 0
Email 100459 0
t.wright@curtin.edu.au
Contact person for scientific queries
Name 100460 0
Prof Tony Wright
Address 100460 0
School of Physiotherapy and Exercise Science, Curtin University, GPO Box U1987, Perth, WA 6845.
Country 100460 0
Australia
Phone 100460 0
+61 401 103 476
Fax 100460 0
Email 100460 0
t.wright@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results