Fenugreek Wraps in Osteoarthritis of the Knee

Universität Duisburg-Essen81 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

Fenugreek wrapOTHER

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

Diclofenac GelDRUG

Daily application of diclofenac gel, 4 weeks application

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

• Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen

Essen, Germany

Outcomes

Primary Outcomes

Pain intensity

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

Time frame: 4 weeks

Secondary Outcomes

knee function (WOMAC)

physical everyday function using the validated WOMAC questionnaire

Time frame: 4 weeks

measure yourself medical outcome profile (MYMOP)

evaluation of symptoms and limitations

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

Course of Pain

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

Time frame: 4 weeks

Pressure pain sensitivity

measured by an algometer at predefined areas

Time frame: 4 weeks

Adverse events Safety measure

Data from ClinicalTrials.gov

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