Back to resultsCabbage Leaf Wraps in Osteoarthritis of the Knee (KoGon)
Primary Purpose
Osteoarthritis of the Knee
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cabbage leave wraps
Diclofenac Gel
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee
Eligibility Criteria
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
Sites / Locations
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Cabbage leaf wraps
Diclofenac gel
Usual care
Arm Description
Daily application of cabbage leaf wraps over night, 4 weeks application
daily application of diclofenac gel 4 weeks application
no specific intervention
Outcomes
Primary Outcome Measures
Pain intensity
pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)
Secondary Outcome Measures
knee function (WOMAC)
physical everyday function using the validated WOMAC questionnaire
Quality of Life (SF-36)
health related quality of life with the validated SF-36 questionnaire
self-efficacy (ASES-D)
self-efficacy with the arthritis specific self efficacy scale in German
physical function (30second chair test)
validated test to measure how often patients can stand up from a chair in 30 seconds)
Pressure pain sensitivity
measured by an algometer at predefined areas
Adverse events
Safety measure
knee function (WOMAC)
physical everyday function using the validated WOMAC questionnaire
Quality of Life (SF-36)
health related quality of life with the validated SF-36 questionnaire
self-efficacy (ASES-D)
self-efficacy with the arthritis specific self efficacy scale in German
physical function (30second chair test)
validated test to measure how often patients can stand up from a chair in 30 seconds)
Pressure pain sensitivity
measured by an algometer at predefined areas
Adverse events
Safety measure
Pain intensity
pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)
Full Information
NCT ID
NCT02027792
First Posted
January 3, 2014
Last Updated
April 30, 2018
Sponsor
Universität Duisburg-Essen
1. Study Identification
Unique Protocol Identification Number
NCT02027792
Brief Title
Cabbage Leaf Wraps in Osteoarthritis of the Knee
Acronym
KoGon
Official Title
Randomised Controlled Trial on the Efficacy of Cabbage Leaf Wraps in Symptomatic Primary Osteoarthritis of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cabbage leaf wraps
Arm Type
Experimental
Arm Description
Daily application of cabbage leaf wraps over night, 4 weeks application
Arm Title
Diclofenac gel
Arm Type
Active Comparator
Arm Description
daily application of diclofenac gel 4 weeks application
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
no specific intervention
Intervention Type
Other
Intervention Name(s)
Cabbage leave wraps
Intervention Type
Drug
Intervention Name(s)
Diclofenac Gel
Primary Outcome Measure Information:
Title
Pain intensity
Description
pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
knee function (WOMAC)
Description
physical everyday function using the validated WOMAC questionnaire
Time Frame
4 weeks
Title
Quality of Life (SF-36)
Description
health related quality of life with the validated SF-36 questionnaire
Time Frame
4 weeks
Title
self-efficacy (ASES-D)
Description
self-efficacy with the arthritis specific self efficacy scale in German
Time Frame
4 weeks
Title
physical function (30second chair test)
Description
validated test to measure how often patients can stand up from a chair in 30 seconds)
Time Frame
4 weeks
Title
Pressure pain sensitivity
Description
measured by an algometer at predefined areas
Time Frame
4 weeks
Title
Adverse events
Description
Safety measure
Time Frame
4 weeks
Title
knee function (WOMAC)
Description
physical everyday function using the validated WOMAC questionnaire
Time Frame
12 weeks
Title
Quality of Life (SF-36)
Description
health related quality of life with the validated SF-36 questionnaire
Time Frame
12 weeks
Title
self-efficacy (ASES-D)
Description
self-efficacy with the arthritis specific self efficacy scale in German
Time Frame
12 weeks
Title
physical function (30second chair test)
Description
validated test to measure how often patients can stand up from a chair in 30 seconds)
Time Frame
12 weeks
Title
Pressure pain sensitivity
Description
measured by an algometer at predefined areas
Time Frame
12 weeks
Title
Adverse events
Description
Safety measure
Time Frame
12 weeks
Title
Pain intensity
Description
pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Course of Pain
Description
measured by a diary including pain intensity on a visual analogue scale, medication
Time Frame
12 weeks
Title
Satisfaction
Description
Satisfaction with either treatments
Time Frame
20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
City
Essen
ZIP/Postal Code
45276
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
26889617
Citation
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.
Results Reference
result
Learn more about this trial
Cabbage Leaf Wraps in Osteoarthritis of the Knee
We'll reach out to this number within 24 hrs