Fenugreek Wraps in Osteoarthritis of the Knee

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: Diclofenac Gel; Other: Fenugreek wrap

• Registration Number: NCT03528824
• Lead Sponsor: Universität Duisburg-Essen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-06
• Study First Submitted QC: 2018-05-06
• Study First Posted: 2018-05-18
• Study Start: 2018-06-01
• Primary Completion: 2020-08-01
• Study Completion: 2020-09-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diclofenac gel	Diclofenac Gel	Daily application of diclofenac gel, 4 weeks application
Fenugreek wraps	Fenugreek wrap	Daily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application

Primary Outcome Measures

Name	Time	Method
Pain intensity	4 weeks	pain intensity measured on three 0-100mm visual analogous scales (actual, mean, worst pain)

Secondary Outcome Measures

Name	Time	Method
Course of Pain	12 weeks	measured by a diary including pain intensity on a visual analogue scale, medication
Pressure pain sensitivity	4 weeks	measured by an algometer at predefined areas
knee function (WOMAC)	12 weeks	physical everyday function using the validated WOMAC questionnaire
measure yourself medical outcome profile (MYMOP)	12 weeks	evaluation of symptoms and limitations
Pain intensity	12 weeks	pain intensity measured on a three 0-100mmvisual analogous scales (actual, mean, worst pain)
Quality of Life (SF-36)	12 weeks	health related quality of life with the validated SF-36 questionnaire
self-efficacy (ASES-D)	12 weeks	self-efficacy with the arthritis specific self efficacy scale in German
physical function (30second chair test)	4 weeks	validated test to measure how often patients can stand up from a chair in 30 seconds)
Adverse events Safety measure	4 weeks	safety measure
Adverse events	12 weeks	safety measure

Trial Locations

Locations (1)

• Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen; 🇩🇪 Essen, Germany