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Completed

NCT Number: NCT03528824

Fenugreek Wraps in Osteoarthritis of the Knee

This randomised controlled trial aims to investigate the efficacy of fenugreek wraps in the treatment of primary symptomatic osteoarthritis of the knee. 81 patients will be randomised into one of 3 groups and apply fenugreek wraps or diclofenac gel daily for 4 weeks or receive only usual care. Efficacy will be measured using questionnaire on pain, disability,function, quality of life and pressure pain sensitivity.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis 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, Faculty of Medicine, University of Duisburg-Essen

Essen, 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 in past 3 months
  • initial pain intensity >45mm on a 100mm visual analoge scale

Exclusion criteria

  • systemic medication with corticoids or immunosuppressive drugs
  • systemic medication with chondroitinsulfate or glucosamine
  • secondary arthrosis
  • operation on the knee within the past 12 months
  • injection within 4 weeks (cortisone) or 6 months prior (hyaluronic acid)
  • severe comorbidities (tumor, psychiatric disorders etc.)
  • participation in other studies, regarding gonarthrosis
  • asthma
  • pregnancy, breastfeeding

Treatment and study plan

Fenugreek wrap

Other

Daily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application

Diclofenac Gel

Drug

Daily application of diclofenac gel, 4 weeks application

Other names: Diclofenac Emulgel

Primary outcomes

  1. Pain intensity

    Time frame: 4 weeks

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

Secondary outcomes

  1. knee function (WOMAC)

    Time frame: 4 weeks

    physical everyday function using the validated WOMAC questionnaire

  2. measure yourself medical outcome profile (MYMOP)

    Time frame: 4 weeks

    evaluation of symptoms and limitations

  3. Quality of Life (SF-36)

    Time frame: 4 weeks

    health related quality of life with the validated SF-36 questionnaire

  4. self-efficacy (ASES-D)

    Time frame: 4 weeks

    self-efficacy with the arthritis specific self efficacy scale in German

  5. 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)

  6. Course of Pain

    Time frame: 4 weeks

    measured by a diary including pain intensity on a visual analogue scale, medication

  7. Pressure pain sensitivity

    Time frame: 4 weeks

    measured by an algometer at predefined areas

  8. Adverse events Safety measure

    Time frame: 4 weeks

    safety measure

  9. knee function (WOMAC)

    Time frame: 12 weeks

    physical everyday function using the validated WOMAC questionnaire

  10. measure yourself medical outcome profile (MYMOP)

    Time frame: 12 weeks

    evaluation of symptoms and limitations

  11. Quality of Life (SF-36)

    Time frame: 12 weeks

    health related quality of life with the validated SF-36 questionnaire

  12. self-efficacy (ASES-D)

    Time frame: 12 weeks

    self-efficacy with the arthritis specific self efficacy scale in German

  13. Course of Pain

    Time frame: 12 weeks

    measured by a diary including pain intensity on a visual analogue scale, medication

  14. Adverse events

    Time frame: 12 weeks

    safety measure

  15. Pain intensity

    Time frame: 12 weeks

    pain intensity measured on a three 0-100mmvisual analogous scales (actual, mean, worst pain)

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

Randomised Controlled Trial on the Efficacy of Fenugreek Wraps in Symptomatic Primary Gonarthrosis

Acronym: BoGon

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 18, 2018
Registry last updated
Oct 6, 2021

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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