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

NCT ID: NCT00317655

Last Updated: 2007-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-04-30

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

Conditions

Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Glucosamine sulphate

Intervention Type: DRUG

Ginger

Intervention Type: DRUG

Ginger-Avocado-Soya

Intervention Type: DRUG

Ginger-ibuprofen

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferrosan AS

INDUSTRY

Sponsor Role: lead

Principal Investigators

Keld Østergaard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Slidgigtinstituttet A/S

Locations

Slidgigtinstituttet A/S

Ishøj, , Denmark

Countries

Denmark

Other Identifiers

Eudractnr. 2005-002691-15

Identifier Type: -

Identifier Source: secondary_id

Jointcare/Fe/1/DK

Identifier Type: -

Identifier Source: org_study_id