Knee Related Walking Limitations Clinical Trial
Knee related mobility limitations are the leading cause of disability in the western world.
It is a very expensive and debilitating condition when the cost of lost productivity and
personal assistance is considered.
In recent years there has been a growing interest in alternative medicine and many
individuals seek such treatments. Rosehip, that is sold as a nutritional supplement, has
been particular popular, and has been shown effective in relieiving pain - albeit the
evidence is scarce.
The purpose of this study is to evaluate the efficacy of specialized rosehip powder
nutritional additives (Rosenoids®) on knee joint function during walking in subjects with
knee-related walking limitations.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
Inclusion Criteria: - Aged above 40 - Self-reported knee-related walking disability - In general good health, in the opinion of the Investigator, based on medical history and physical examination and, if necessary, laboratory values. Laboratory tests are prescribed by the Investigator at the screening visit. - A body mass index (BMI) of =35 kg/m2 - Speaks, reads and writes Danish language Exclusion Criteria: - Usage of Rosehip nutritional supplements within the last 3 months - History of symptoms of autoimmune disorders. - Planned surgical procedure during the duration of the study - History, diagnosis, or signs and symptoms of clinically significant neurological disease - Alcohol or drug abuse within the last 5 years - History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder - Subjects with regional pain syndromes suggestive of lumbar compressions with radiculopathy or at risk of developing radiculopathy. - Any other condition, which in the opinion of the Investigator, would put the subject at increased safety risk or otherwise make the subject unsuitable for this study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | The Parker Institute, Frederiksberg Hospital | Copenhagen |
| Lead Sponsor | Collaborator |
|---|---|
| Frederiksberg University Hospital |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Capsule count | Number of capsules returned in relation to number of capsules provided. | week 12 | No |
| Primary | Knee joint biomechanics during walking | 3-D kinematic gait data is obtained using a 6-camera Motion Analysis System sampling at 100 Hz capturing positions and movements of reflective markers placed on the skin and arranged in the Plug-in-Gait configuration. Ground reaction forces and moments are obtained with two 6-channel force platforms (Advanced Mechanical Technologies, Inc., Newton, MA, USA) operating at 1500 Hz synchronized with the camera system. Specialized software is used to generate lower extremity angular kinematic and kinetic data using inverse dynamics. | 12 weeks | No |
| Secondary | Circulating levels of C-reactive protein (blood samples) | 12 weeks | No | |
| Secondary | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | A questionnaire with suggestive leading questions, assessing adverse events at large - not necessarily adverse effects in a generic framework using options based on standards applied previously is used. | week 12 | No |
| Secondary | Physician global assessment of patient disease | Physician's global assessment of overall health at clinical visits is scored on a 100 mm visual analogue scale (VAS) | week 12 | No |
| Secondary | Self-reported status of the participants' knee and associated problems | Knee Osteoarthritis and Injury Outcome Score (KOOS) | week 12 | No |
| Secondary | Self-reported health and well-being | Self-reported questionnaire. | week 12 | No |
| Secondary | Circulating levels of Alanine AminoTransferase (blood samples) | 12 weeks | No | |
| Secondary | Circulating levels of Alkaline Phosphatase (blood samples) | 12 weeks | No |