Osteoarthritis, Knee
Conditions
Brief summary
This is a double-blind placebo controlled trial whose objective is to understand how much the radial extracorporeal shockwave therapy can improve function of patients with knee osteoarthritis. For this trial, patients with knee osteoarthritis, after signing the informed consent form and having their demographic and baseline information collected, will be randomly allocated into one of both treatment arms: radial extracorporeal shockwave therapy (rESWT) or sham radial extracorporeal shockwave therapy. Then, they will undertake three sessions of rESWT, for three weeks, i.e. one session per week. Patients will be assessed prior to the therapy, one week after the end of the therapy and three months after the end of the therapy, and the primary outcome of this study is the functional change measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) validated in Portuguese, three months after the end of the therapy. Secondary outcomes, will be the change of pain, the change of pressure pain tolerance threshold, change in diffuse noxious inhibitory control (DNIC), and thermographic changes.
Interventions
DEVICEActive rESWT
5,000 pulses of rESWT, with 0.16mJ/mm2 of energy at a frequency of 20Hz once a week for three weeks.
DEVICESham rESWT
5,000 pulses of rESWT, with 0.0 mJ/mm2 of energy at a frequency of 20Hz once a week for three weeks.
Sponsors
Marta Imamura
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of knee osteoarthritis; * Onset knee pain with moderate or severe intensity: Visual Analogue Scale (VAS) \> 4; * Onset knee pain over 3 months prior to the inclusion;
Exclusion criteria
* Presence of psychiatric disease; * Presence of fibromyalgia; * Presence of systemic inflammatory rheumatic diseases; * History of neoplasia; * Presence of clinical diseases in other joints; * Ongoing use of anticoagulant drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Change | At baseline and three months after the end of the treatment. | Functional change from baseline, measured by KOOS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Term Functional Changes | At baseline and one week after the end of the treatment. | Functional change from baseline, measured by KOOS |
| Knee pain reduction | At baseline, one week and three months after the end of the treatment | Knee pain changes from baseline, measured by KOOS |
| Pain pressure threshold tolerance changes | At baseline, one week and three months after the end of the treatment | Changes in pain pressure threshold tolerance over time, measured by algometer |
| Diffuse noxious inhibitory control alterations | At baseline, one week and three months after the end of the treatment | Changes in diffuse noxious inhibitory control over time, measured by algometer |
| Thermography evaluation | At baseline, one week and three months after the end of the treatment | Changes thermographic characteristics of lower limbs and knee over time, measured by Infrared Thermography |
Countries
Brazil
Outcome results
None listed