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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fenugreek wraps | Experimental | Daily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application |
|
| Diclofenac gel | Active Comparator | Daily application of diclofenac gel, 4 weeks application |
|
| Usual care | No Intervention | no specific intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenugreek wrap | Other | Daily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | pain intensity measured on three 0-100mm visual analogous scales (actual, mean, worst pain) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| knee function (WOMAC) | physical everyday function using the validated WOMAC questionnaire | 4 weeks |
| measure yourself medical outcome profile (MYMOP) | evaluation of symptoms and limitations |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| • Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen | Essen | Germany |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Diclofenac Gel | Drug | Daily application of diclofenac gel, 4 weeks application |
|
|
| 4 weeks |
| Quality of Life (SF-36) | health related quality of life with the validated SF-36 questionnaire | 4 weeks |
| self-efficacy (ASES-D) | self-efficacy with the arthritis specific self efficacy scale in German | 4 weeks |
| physical function (30second chair test) | validated test to measure how often patients can stand up from a chair in 30 seconds) | 4 weeks |
| Course of Pain | measured by a diary including pain intensity on a visual analogue scale, medication | 4 weeks |
| Pressure pain sensitivity | measured by an algometer at predefined areas | 4 weeks |
| Adverse events Safety measure | safety measure | 4 weeks |
| knee function (WOMAC) | physical everyday function using the validated WOMAC questionnaire | 12 weeks |
| measure yourself medical outcome profile (MYMOP) | evaluation of symptoms and limitations | 12 weeks |
| Quality of Life (SF-36) | health related quality of life with the validated SF-36 questionnaire | 12 weeks |
| self-efficacy (ASES-D) | self-efficacy with the arthritis specific self efficacy scale in German | 12 weeks |
| Course of Pain | measured by a diary including pain intensity on a visual analogue scale, medication | 12 weeks |
| Adverse events | safety measure | 12 weeks |
| Pain intensity | pain intensity measured on a three 0-100mmvisual analogous scales (actual, mean, worst pain) | 12 weeks |
| D012216 |
| Rheumatic Diseases |