Cabbage Leaf Wraps in Osteoarthritis of the Knee

Osteoarthritis of the Knee Clinical Trial

— KoGon  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027792
• Other study ID #: 13-5581 KoGon
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: April 2018
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Other:
• Cabbage leave wraps

Drug:
• Diclofenac Gel

Locations

Country	Name	City	State
Germany	Department of Internal and Integrative Medicine, Kliniken Essen-Mitte	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Lauche R, Gräf 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Course of Pain	measured by a diary including pain intensity on a visual analogue scale, medication	12 weeks
Other	Satisfaction	Satisfaction with either treatments	20 weeks
Primary	Pain intensity	pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)	4 weeks
Secondary	knee function (WOMAC)	physical everyday function using the validated WOMAC questionnaire	4 weeks
Secondary	Quality of Life (SF-36)	health related quality of life with the validated SF-36 questionnaire	4 weeks
Secondary	self-efficacy (ASES-D)	self-efficacy with the arthritis specific self efficacy scale in German	4 weeks
Secondary	physical function (30second chair test)	validated test to measure how often patients can stand up from a chair in 30 seconds)	4 weeks
Secondary	Pressure pain sensitivity	measured by an algometer at predefined areas	4 weeks
Secondary	Adverse events	Safety measure	4 weeks
Secondary	knee function (WOMAC)	physical everyday function using the validated WOMAC questionnaire	12 weeks
Secondary	Quality of Life (SF-36)	health related quality of life with the validated SF-36 questionnaire	12 weeks
Secondary	self-efficacy (ASES-D)	self-efficacy with the arthritis specific self efficacy scale in German	12 weeks
Secondary	physical function (30second chair test)	validated test to measure how often patients can stand up from a chair in 30 seconds)	12 weeks
Secondary	Pressure pain sensitivity	measured by an algometer at predefined areas	12 weeks
Secondary	Adverse events	Safety measure	12 weeks
Secondary	Pain intensity	pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)	12 weeks