We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cabbage Leaf Wraps in Osteoarthritis of the Knee (KoGon)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02027792
Recruitment Status : Completed
First Posted : January 6, 2014
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Romy Lauche, Universität Duisburg-Essen

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Other: Cabbage leave wraps Drug: Diclofenac Gel Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial on the Efficacy of Cabbage Leaf Wraps in Symptomatic Primary Osteoarthritis of the Knee
Study Start Date : January 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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
No Intervention: Usual care
no specific intervention



Primary Outcome Measures :
  1. Pain intensity [ Time Frame: 4 weeks ]
    pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)


Secondary Outcome Measures :
  1. knee function (WOMAC) [ Time Frame: 4 weeks ]
    physical everyday function using the validated WOMAC questionnaire

  2. Quality of Life (SF-36) [ Time Frame: 4 weeks ]
    health related quality of life with the validated SF-36 questionnaire

  3. self-efficacy (ASES-D) [ Time Frame: 4 weeks ]
    self-efficacy with the arthritis specific self efficacy scale in German

  4. physical function (30second chair test) [ Time Frame: 4 weeks ]
    validated test to measure how often patients can stand up from a chair in 30 seconds)

  5. Pressure pain sensitivity [ Time Frame: 4 weeks ]
    measured by an algometer at predefined areas

  6. Adverse events [ Time Frame: 4 weeks ]
    Safety measure

  7. knee function (WOMAC) [ Time Frame: 12 weeks ]
    physical everyday function using the validated WOMAC questionnaire

  8. Quality of Life (SF-36) [ Time Frame: 12 weeks ]
    health related quality of life with the validated SF-36 questionnaire

  9. self-efficacy (ASES-D) [ Time Frame: 12 weeks ]
    self-efficacy with the arthritis specific self efficacy scale in German

  10. physical function (30second chair test) [ Time Frame: 12 weeks ]
    validated test to measure how often patients can stand up from a chair in 30 seconds)

  11. Pressure pain sensitivity [ Time Frame: 12 weeks ]
    measured by an algometer at predefined areas

  12. Adverse events [ Time Frame: 12 weeks ]
    Safety measure

  13. Pain intensity [ Time Frame: 12 weeks ]
    pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)


Other Outcome Measures:
  1. Course of Pain [ Time Frame: 12 weeks ]
    measured by a diary including pain intensity on a visual analogue scale, medication

  2. Satisfaction [ Time Frame: 20 weeks ]
    Satisfaction with either treatments



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02027792


Locations
Layout table for location information
Germany
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Essen, Germany, 45276
Sponsors and Collaborators
Universität Duisburg-Essen
Publications of Results:
Layout table for additonal information
Responsible Party: Romy Lauche, Principle investigator, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT02027792    
Other Study ID Numbers: 13-5581 KoGon
First Posted: January 6, 2014    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action