Fenugreek Wraps in Osteoarthritis of the Knee (BoGon)

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

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 Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Other: Fenugreek wrap; Drug: Diclofenac Gel

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fenugreek wraps; Daily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application	Other: Fenugreek wrap; Daily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application
Active Comparator: Diclofenac gel; Daily application of diclofenac gel, 4 weeks application	Drug: Diclofenac Gel; Daily application of diclofenac gel, 4 weeks application; Other Names: Diclofenac Emulgel
No Intervention: Usual care; no specific intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	pain intensity measured on three 0-100mm visual analogous scales (actual, mean, worst pain)	4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: May 6, 2018
• First Submitted That Met QC Criteria: May 6, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: BoGon

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No