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This randomised controlled trial aims to investigate the efficacy of cabbage leaf cataplasms in the treatment of primary symptomatic osteoarthritis of the knee. 81 patients will be randomised into one of 3 groups and apply either cabbage leaf cataplasm or diclofenac gel daily for 4 weeks or receive only usual care. Efficacy will be measured using questionnaire on pain, disability, quality of life and pressure pain sensitivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cabbage leaf wraps | Experimental | Daily application of cabbage leaf wraps over night, 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 |
|---|---|---|---|---|
| Cabbage leave wraps | Other |
| ||
| Diclofenac Gel |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| knee function (WOMAC) | physical everyday function using the validated WOMAC questionnaire | 4 weeks |
| Quality of Life (SF-36) | health related quality of life with the validated SF-36 questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Course of Pain | measured by a diary including pain intensity on a visual analogue scale, medication | 12 weeks |
| Satisfaction | Satisfaction with either treatments |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal and Integrative Medicine, Kliniken Essen-Mitte | Essen | 45276 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26889617 | Result | Lauche R, Graf N, Cramer H, Al-Abtah J, Dobos G, Saha FJ. Efficacy of Cabbage Leaf Wraps in the Treatment of Symptomatic Osteoarthritis of the Knee: A Randomized Controlled Trial. Clin J Pain. 2016 Nov;32(11):961-971. doi: 10.1097/AJP.0000000000000352. |
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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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|
| 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 |
| Pressure pain sensitivity | measured by an algometer at predefined areas | 4 weeks |
| Adverse events | Safety measure | 4 weeks |
| knee function (WOMAC) | physical everyday function using the validated WOMAC questionnaire | 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 |
| physical function (30second chair test) | validated test to measure how often patients can stand up from a chair in 30 seconds) | 12 weeks |
| Pressure pain sensitivity | measured by an algometer at predefined areas | 12 weeks |
| Adverse events | Safety measure | 12 weeks |
| Pain intensity | pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain) | 12 weeks |
| 20 weeks |
| D012216 |
| Rheumatic Diseases |