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Completed

NCT Number: NCT02027792

Cabbage Leaf Wraps in 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.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Essen, 45276, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cabbage leave wraps

Other

Diclofenac Gel

Drug

Primary outcomes

  1. Pain intensity

    Time frame: 4 weeks

    pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

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

Acronym: KoGon

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 6, 2014
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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