Fenugreek Wraps in Osteoarthritis of the Knee

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Other: Fenugreek wrap
* Drug: Diclofenac Gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |