Knee Osteoarthritis, Obesity Clinical Trial
| Verified date | September 2013 |
| Source | University of Padua |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Interventional |
The aim of the study is to evaluate the role of balneotherapy in obese patients with knee osteoarthritis in terms of pain relief, improving joint function and deambulation, on endocrinological parameters, quality of life and of reduction the costs to "Servizio Sanitario Nazionale" (NHS).
| Status | Not yet recruiting |
| Enrollment | 74 |
| Est. completion date | September 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - obesity II-III grade (BMI 35-45 kg/m2) - knee pain - patient compliance to the treatment Exclusion Criteria: - BMI<34,9kg/m2 or BMI> 45,1kg/m2 - previous knee surgery - complicated diabetes mellitus - ischemic cardiomyopathy and heart failure - acute phase of osteoarthritis - varicose veins, deep venous thrombosis (DVT) - cancer - cutaneous lesions - NSAIDs administration <1 week before the treatment - knee infiltration <2 months before the treatment |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Italy | Azienda Ospedaliera-Università degli studi di Padova | Padua |
| Lead Sponsor | Collaborator |
|---|---|
| University of Padua |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Knee pain measurement with Visual Analogue Scale (VAS) | At the begining and at the end of the treatment. After 6 months of the end of therapy | No | |
| Secondary | Knee range of motion | At the begining and at the end of the treatment. After 6 months of the end of therapy | No |