An interventional study of Cabbage leave wraps and Diclofenac Gel in Osteoarthritis of the Knee, sponsored by Universität Duisburg-Essen. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-02.
Sponsored by Universität Duisburg-Essen · Not applicable, Interventional, and Treatment
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.
4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.
This study's enrollment of 81 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Universität Duisburg-Essen is the lead sponsor of 82 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Daily application of cabbage leaf wraps over night, 4 weeks application
Other: Cabbage leave wraps
daily application of diclofenac gel 4 weeks application
Drug: Diclofenac Gel
no specific intervention
Pain intensity
pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)
Time frame: 4 weeks
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
Time frame: 12 weeks
self-efficacy (ASES-D)
self-efficacy with the arthritis specific self efficacy scale in German
Time frame: 12 weeks
physical function (30second chair test)
validated test to measure how often patients can stand up from a chair in 30 seconds)
Time frame: 12 weeks
Pressure pain sensitivity
measured by an algometer at predefined areas
Time frame: 12 weeks
Adverse events
Safety measure
Time frame: 12 weeks
Pain intensity
pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)
Time frame: 12 weeks
Course of Pain
measured by a diary including pain intensity on a visual analogue scale, medication
Time frame: 12 weeks
Satisfaction
Satisfaction with either treatments
Time frame: 20 weeks
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Universität Duisburg-Essen