Cabbage Leaf Wraps in Osteoarthritis of the Knee

Study Overview
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Brief Summary
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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.

Official Title
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Randomised Controlled Trial on the Efficacy of Cabbage Leaf Wraps in Symptomatic Primary Osteoarthritis of the Knee

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Other: Cabbage leave wraps
* Drug: Diclofenac Gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cabbage leaf wraps<br>Daily application of cabbage leaf wraps over night, 4 weeks application | Other: Cabbage leave wraps<br> <br> |
| Active Comparator: Diclofenac gel<br>daily application of diclofenac gel 4 weeks application | Drug: Diclofenac Gel<br> <br> |
| No Intervention: Usual care<br>no specific intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |