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

Back Pain Clinical Trial

Official title:

Glucosamine Sulphate, Ginger, Ginger-Avocado-Soya and Ginger-Ibuprofen for Chronic Back Pain - a Randomized, Double Blind, Placebo-Controlled Clinical Investigation With Parallel Groups for 3 Months to Enlighten Joint Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00317655
• Other study ID #: Jointcare/Fe/1/DK
• Secondary ID: Eudractnr. 2005-
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2006
• Last updated: May 16, 2007
• Start date: April 2006
• Est. completion date: April 2007

Study information

• Verified date: May 2007
• Source: Ferrosan AS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain

Intervention

Drug:
• Glucosamine sulphate

• Ginger

• Ginger-Avocado-Soya

• Ginger-ibuprofen

Locations

Country	Name	City	State
Denmark	Slidgigtinstituttet A/S	Ishoj

Sponsors (1)

Lead Sponsor	Collaborator
Ferrosan AS

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mm pain relief (visual analog scale [VAS]) during past 24 hours compared from start (0 weeks) and 12 weeks
Secondary	Percentage of responders showing more than 15 mm improvement in pain relief
Secondary	mm pain relief (VAS) within past 7 days at weeks 1, 2, 4, 6, 9, and 12
Secondary	Function level according to Roland Morris-questionnaire (23 points)
Secondary	Patients' Global Impression of Change (pain)
Secondary	Patients' satisfaction with pain medication
Secondary	Use of rescue medication
Secondary	Adverse events profile
Secondary	Body weight (start and 12 weeks)