Cabbage Leaf Wraps in Osteoarthritis of the Knee

Not Applicable

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Other: Cabbage leave wraps; Drug: Diclofenac Gel

• Registration Number: NCT02027792
• Lead Sponsor: Universität Duisburg-Essen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-03
• Study First Submitted QC: 2014-01-03
• Study First Posted: 2014-01-06
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cabbage leaf wraps	Cabbage leave wraps	Daily application of cabbage leaf wraps over night, 4 weeks application
Diclofenac gel	Diclofenac Gel	daily application of diclofenac gel 4 weeks application

Primary Outcome Measures

Name	Time	Method
Pain intensity	4 weeks	pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)

Secondary Outcome Measures

Name	Time	Method
knee function (WOMAC)	12 weeks	physical everyday function using the validated WOMAC questionnaire
Quality of Life (SF-36)	12 weeks	health related quality of life with the validated SF-36 questionnaire
self-efficacy (ASES-D)	12 weeks	self-efficacy with the arthritis specific self efficacy scale in German
physical function (30second chair test)	12 weeks	validated test to measure how often patients can stand up from a chair in 30 seconds)
Pressure pain sensitivity	12 weeks	measured by an algometer at predefined areas
Adverse events	12 weeks	Safety measure
Pain intensity	12 weeks	pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)

Trial Locations

Locations (1)

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte; 🇩🇪 Essen, Germany