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

Ferrosan

Status and phase

Completed

Phase 4

Conditions

Back Pain

Treatments

Drug: Ginger-ibuprofen

Drug: Ginger-Avocado-Soya

Drug: Ginger

Drug: Glucosamine sulphate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00317655

Eudractnr. 2005-002691-15

Jointcare/Fe/1/DK

Details and patient eligibility

About

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.

Enrollment

175 patients

Sex

All

Ages

30 to 85 years old

Volunteers

No Healthy Volunteers

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