Assessing the clinical benefit of food supplement, Genecol®, in subjects with joint pain at the lower, upper limbs or at the lumbar spine

Completed

• Conditions: Joint pain; Musculoskeletal Diseases; Other joint disorders, not elsewhere classified

• Registration Number: ISRCTN76960238
• Lead Sponsor: utraveris (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Men and women over 50 years with joint pain (hip, knee, elbow, shoulder, hand and lumbar spine) over 30 mm on a 0-100 mm visual analogue scale.

Exclusion Criteria

1. Unlikely to cooperate in the study
2. Poor compliance anticipated by the investigator
3. Participating in another trial at the same time or within the previous 1 month with active therapeutic intervention (except if the patient only performed the screening visit without taking the tested supplement)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of clinical responders between the active treatment and placebo groups

Secondary Outcome Measures

Name	Time	Method
Outcomes will be evaluated at weeks 12 and 24<br>1. Pain rescue treatment consumption<br>2. Pain/function changes; assessed by <br>2.1. Visual analogue scale (VAS)<br>2.2. Lequesne index<br>2.3. Disability of Arm Shoulder and Hand (DASH) score<br>2.4. Functional Disability Scale for the Assessment of Low Back Pain (Echelle d'Incapacité Fonctionnelle pour l'Evaluation des Lombalgies [EIFEL]) questionnaire<br>3. Health-related quality of life changes; assessed with the SF-36<br>4. Utility value changes; assessed by EQ-5D<br>5. Tolerability and incidence of any adverse events<br>6. Global satisfaction of the treatment will be assessed by mean of a global questionnaire (also at week 4)