Low Intensity Knee Gonalgia Clinical Trial
Official title:
Double-blind, Placebo-controlled Nutrition Intervention Trial, to Study Efficacy and Safety of Yogurts Supplemented With Mobilee on Joint Function, Joint Structure and Quality of Life of Adults With Low Intensity Gonalgia
| Verified date | September 2012 |
| Source | Bioiberica |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: Ethics Committee |
| Study type | Interventional |
The purpose of this study is to determine whether the daily eating of a yogurt supplemented with Mobile is effective in improving joint function and quality of life of individuals with low intensity gonalgia.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | June 2011 |
| Est. primary completion date | March 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 20 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Adult (between 20 and 70 years of age) - Subject with low intensity knee gonalgia (VAS pain intensity between 3 and 5cm during at least the last 6 months) - Healthy individual according to its medical records, physical and laboratorial parameters - Positive informed consent Exclusion Criteria: - Individuals requiring acetaminophen or any other drug to control pain - Active rheumatoid arthritis or any other inflammatory joint disease - Oral treatment with corticosteroids 4 weeks before selection - Intra-articular treatment with corticosteroids 3 months before selection - Significant injury of the study joint 12 months before selection - Individuals receiving any drug or supplement for osteoarthritis - Individuals requiring any type of medical prescription to control pain |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitari Sant Joan de Reus | Reus | Tarragona |
| Lead Sponsor | Collaborator |
|---|---|
| Bioiberica | Technological Centre of Nutrition and Health |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in isokineic assessment of muscular strength | The muscular isokinetic assessment determines peak torque, power mean and total work of a certain joint using a dynamometric computerized system. The principal parameter is the change from baseline in the peak torque of the affected joint in extension at a speed of 240º/sec measured in Nm (Newton-meter). | 3 months | No |
| Secondary | Change from baseline in isokinetic assessment of muscular strength (other conditions) | Change from baseline of peak torque (Nm), power mean (W) and total work (J) of the affected joint in extension at 180º/sec, and in flexion at 240º/sec and 180º/sec. | 3 months | No |
| Secondary | Assessment of joint swelling, effusion | Ultrasonography: Study of the synovial effusion degree (if any) measured in the longitudinal axis of the suprapatellar recess of the affected knee.Results are expressed as change from baseline in mm. | 3 months | No |
| Secondary | Pain assessment (VAS) | Time evolution of pain intensity as measured by Visual Analogue Scale (mm). | 3 months | No |
| Secondary | SF-36 Health questionnaire | Questionnaire SF36-v2 to measure physical and mental health. | 3 months | No |
| Secondary | Number of Participants with Adverse Events | The safety assessment includes a register of the appearance of adverse events along the 3 months of the study | 3 months | Yes |
| Secondary | Subjective evaluation of the intervention | Questionnaire to evaluate the subjective perception of the efficacy of the intervention. | 3 months | No |
| Secondary | Change from baseline in systolic blood pressure, hearth rate, general biochemical profile and body mass index at 3 months | Safety assessment includes an evaluation at 3 months of changes from baseline on systolic blood pressure, hearth rate, general biochemical profile and body mass index | 3 months | Yes |