Osteoarthritis, Knee
Conditions
Brief summary
This randomised controlled trial aims to investigate the efficacy of fenugreek wraps in the treatment of primary symptomatic osteoarthritis of the knee. 81 patients will be randomised into one of 3 groups and apply fenugreek wraps or diclofenac gel daily for 4 weeks or receive only usual care. Efficacy will be measured using questionnaire on pain, disability,function, quality of life and pressure pain sensitivity.
Interventions
OTHERFenugreek wrap
Daily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application
DRUGDiclofenac Gel
Daily application of diclofenac gel, 4 weeks application
Sponsors
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* osteoarthritis of the knee, Kellgren Lawrence stadium 2-3 * at least 50% of days with complaints in past 3 months * initial pain intensity \>45mm on a 100mm visual analoge scale
Exclusion criteria
* systemic medication with corticoids or immunosuppressive drugs * systemic medication with chondroitinsulfate or glucosamine * secondary arthrosis * operation on the knee within the past 12 months * injection within 4 weeks (cortisone) or 6 months prior (hyaluronic acid) * severe comorbidities (tumor, psychiatric disorders etc.) * participation in other studies, regarding gonarthrosis * asthma * pregnancy, breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 4 weeks | pain intensity measured on three 0-100mm visual analogous scales (actual, mean, worst pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| measure yourself medical outcome profile (MYMOP) | 4 weeks | evaluation of symptoms and limitations |
| Quality of Life (SF-36) | 4 weeks | health related quality of life with the validated SF-36 questionnaire |
| self-efficacy (ASES-D) | 4 weeks | self-efficacy with the arthritis specific self efficacy scale in German |
| physical function (30second chair test) | 4 weeks | validated test to measure how often patients can stand up from a chair in 30 seconds) |
| knee function (WOMAC) | 4 weeks | physical everyday function using the validated WOMAC questionnaire |
| Pressure pain sensitivity | 4 weeks | measured by an algometer at predefined areas |
| Adverse events Safety measure | 4 weeks | safety measure |
| Adverse events | 12 weeks | safety measure |
| Pain intensity | 12 weeks | pain intensity measured on a three 0-100mmvisual analogous scales (actual, mean, worst pain) |
| Course of Pain | 4 weeks | measured by a diary including pain intensity on a visual analogue scale, medication |
Countries
Germany
Outcome results
None listed