Cabbage Leaf Wraps in Osteoarthritis of the Knee

N/ACompletedNCT02027792

Universität Duisburg-Essen81 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Osteoarthritis of the Knee

Interventions

Cabbage leave wrapsOTHER

Diclofenac GelDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Essen, Germany

Outcomes

Primary Outcomes

Pain intensity

pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)

Time frame: 4 weeks

Secondary Outcomes

knee function (WOMAC)

physical everyday function using the validated WOMAC questionnaire

Time frame: 4 weeks

Quality of Life (SF-36)

health related quality of life with the validated SF-36 questionnaire

Time frame: 4 weeks

self-efficacy (ASES-D)

self-efficacy with the arthritis specific self efficacy scale in German

Time frame: 4 weeks

physical function (30second chair test)

validated test to measure how often patients can stand up from a chair in 30 seconds)

Time frame: 4 weeks

Pressure pain sensitivity

measured by an algometer at predefined areas

Time frame: 4 weeks

Adverse events

Safety measure

Time frame: 4 weeks

knee function (WOMAC)

physical everyday function using the validated WOMAC questionnaire

Time frame: 12 weeks

Quality of Life (SF-36)

health related quality of life with the validated SF-36 questionnaire

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.