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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 May 2023 |
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Main ID: |
NCT03344770 |
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Date of registration:
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13/11/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Efficacy of Radial Extracorporeal Shockwave Therapy on Knee Osteoarthritis
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Scientific title:
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The Efficacy of Radial Extracorporeal Shockwave Therapy (RESWT) for Functional Improvement of Patients With Knee Osteoarthritis - A Double-blind Randomized Trial |
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Date of first enrolment:
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October 20, 2017 |
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Target sample size:
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44 |
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Recruitment status: |
Suspended |
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URL:
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https://clinicaltrials.gov/show/NCT03344770 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Marta Imamura, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto de Medicina Física e Reabilitação HCFMUSP |
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Key inclusion & exclusion criteria
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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.
Age minimum:
50 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteoarthritis, Knee
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Intervention(s)
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Device: Active rESWT
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Device: Sham rESWT
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Primary Outcome(s)
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Functional Change
[Time Frame: At baseline and three months after the end of the treatment.]
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Secondary Outcome(s)
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Short Term Functional Changes
[Time Frame: At baseline and one week after the end of the treatment.]
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Pain pressure threshold tolerance changes
[Time Frame: At baseline, one week and three months after the end of the treatment]
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Diffuse noxious inhibitory control alterations
[Time Frame: At baseline, one week and three months after the end of the treatment]
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Thermography evaluation
[Time Frame: At baseline, one week and three months after the end of the treatment]
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Knee pain reduction
[Time Frame: At baseline, one week and three months after the end of the treatment]
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Secondary ID(s)
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72067817.8.0000.0068
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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