Cabbage Leaf Wraps in Osteoarthritis of the Knee (KoGon)

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

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 Overview

• Status: Completed
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Other: Cabbage leave wraps; Drug: Diclofenac Gel

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany, 45276
    • Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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
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
Adverse events	Safety measure	4 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

Other Outcome Measures

Outcome Measure	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	20 weeks

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: January 3, 2014
• First Submitted That Met QC Criteria: January 3, 2014
• First Posted (Estimate): January 6, 2014

Study Record Updates

• Last Update Posted (Actual): May 2, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: 13-5581 KoGon