None listed
Conditions
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.
Interventions
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 mi
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.
Sponsors
Curtin University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed