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

Phase 4

Completed

• Conditions: Back Pain

• Registration Number: NCT00317655
• Lead Sponsor: Ferrosan AS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-23
• Study First Submitted QC: 2006-04-23
• Study First Posted: 2006-04-25
• Study Completion: 2007-04
• Status Verified: 2007-05
• Last Update Submitted: 2007-05-16
• Last Update Posted: 2007-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
mm pain relief (visual analog scale [VAS]) during past 24 hours compared from start (0 weeks) and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of responders showing more than 15 mm improvement in pain relief
mm pain relief (VAS) within past 7 days at weeks 1, 2, 4, 6, 9, and 12
Function level according to Roland Morris-questionnaire (23 points)
Patients' Global Impression of Change (pain)
Patients' satisfaction with pain medication
Use of rescue medication
Adverse events profile
Body weight (start and 12 weeks)

Trial Locations

Locations (1)

Slidgigtinstituttet A/S; 🇩🇰 Ishoj, Denmark