Status:
COMPLETED
Glucosamine Sulphate, Ginger, Ginger-Avocado-Soya and Ginger-Ibuprofen for Chronic Back Pain
Lead Sponsor:
Ferrosan AS
Conditions:
Back Pain
Eligibility:
All Genders
30-85 years
Phase:
PHASE4
Brief Summary
The main purpose of this study is to investigate the ability of some dietary supplement products to affect general joint health and life quality in a selected population with back pain. The study is ...
Eligibility Criteria
Inclusion
- Chronic back pain daily or almost daily for at least 3 months prior to inclusion
- Patient classified as I or II according to Quebec Task Force
- No intake of glucosamine sulphate, ginger, or avocado-soya extract during last 3 months
- Fertile women should, at start, have a negative pregnancy test and during test use acceptable prevention methods (p-pills, intrauterine device \[IUD\], depot gestagen, subdermal implant, hormonal vaginal ring or transdermal depot plaster).
- Anxiolytics, muscle relaxants, physiotherapy, chiropractic treatment, or training should not have been used during last 3 months.
Exclusion
- Serious disease (eg. heart disease, cancer (within past 5 years), kidney disease, blood diseases, inflammatory diseases (eg. chronic rheumatoid arthritis, fibromyalgia)
- Suspicion that back pain is caused by osteoporosis, other arthritic condition than osteoarthritis, cancer, infection, pain from organ disease or psychosomatic cancer disease.
- Uncontrolled elevated blood pressure, defined as systolic ≥ 160 mm Hg or diastolic ≥ 90 mm Hg.
- VAS measurement at inclusion less than ved 30 mm or over 90 mm.
- Prehistory of ulcer, stomach surgery, or inflammatory bowel disease
- Pain relief medication besides must not be taken during study.
- Patients in need of non-steroidal anti-inflammatory drugs (NSAIDs), morphine, or similar medication are not eligible. Same is also valid for patients in need of injections or acupuncture.
- Back surgery within 6 months before inclusion or earlier surgery without effect
- "Heart" aspirin (low dose), ulcer medication, or blood thinning medication
- Alcohol abuse
- Depression
- Pregnancy or breastfeeding
- Allergy to crustaceans or known intolerance for glucosamine sulphate, ginger, avocado, soy, or ibuprofen
- Allergy or asthma released by salicylic acid or other arthritis medication (NSAIDs)
- Patient who is seeking pension due to back pain or has other economical interests connected to his/her back pain
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00317655
Start Date
April 1 2006
End Date
April 1 2007
Last Update
May 17 2007
Active Locations (1)
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1
Slidgigtinstituttet A/S
Ishøj, Denmark, 2635