Glucosamine Sulphate, Ginger, Ginger-Avocado-Soya and Ginger-Ibuprofen for Chronic Back Pain

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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 randomized and double - blind, with parallel groups receiving treatment for a duration of 12 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferrosan AS
• Treatments: Ibuprofen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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