The Efficacy of Radial Extracorporeal Shockwave Therapy (RESWT) for Functional Improvement of Patients With Knee Osteoarthritis - A Double-blind Randomized Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Marta Imamura
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Functional Change
- Status
- Suspended
- Last Updated
- last year
Overview
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.
Investigators
Marta Imamura
Principal Investigator
University of Sao Paulo
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Functional Change
Time Frame: At baseline and three months after the end of the treatment.
Functional change from baseline, measured by KOOS.
Secondary Outcomes
- Pain pressure threshold tolerance changes(At baseline, one week and three months after the end of the treatment)
- Thermography evaluation(At baseline, one week and three months after the end of the treatment)
- Diffuse noxious inhibitory control alterations(At baseline, one week and three months after the end of the treatment)
- Short Term Functional Changes(At baseline and one week after the end of the treatment.)
- Knee pain reduction(At baseline, one week and three months after the end of the treatment)