Osteoarthritis of the Knee
Conditions
Brief summary
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.
Interventions
OTHERCabbage leave wraps
DRUGDiclofenac Gel
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 * initial pain intensity 45mm on a 100mm visual analoge scale
Exclusion criteria
* medication with corticoids or immunsupressing drugs * secondary arthritis/arthrosis * operation to the knee within 12 months prior * injection within 4 weeks (cortison) or 6 months prior (hyaluronic acid) * severe comorbidities (liver, kidney, asthma, psychiatric disorders etc.) * participation in other studies * pregnancy, breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 4 weeks | pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| knee function (WOMAC) | 4 weeks | physical everyday function using the validated WOMAC questionnaire |
| 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) |
| Adverse events | 4 weeks | Safety measure |
| Pain intensity | 12 weeks | pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain) |
| Pressure pain sensitivity | 4 weeks | measured by an algometer at predefined areas |
Other
| Measure | Time frame | Description |
|---|---|---|
| Course of Pain | 12 weeks | measured by a diary including pain intensity on a visual analogue scale, medication |
| Satisfaction | 20 weeks | Satisfaction with either treatments |
Countries
Germany
Outcome results
None listed