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

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

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.

Study Overview

• Status: Completed
• Conditions: Back Pain
• Intervention / Treatment: Drug: Ginger; Drug: Glucosamine sulphate; Drug: Ginger-Avocado-Soya; Drug: Ginger-ibuprofen

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Ishoj, Denmark, 2635
    • Slidgigtinstituttet A/S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Use of rescue medication
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
Adverse events profile
Body weight (start and 12 weeks)

Collaborators and Investigators

• Sponsor: Ferrosan AS
• Investigators: Principal Investigator: Keld Østergaard, MD, PhD, Slidgigtinstituttet A/S

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Study Completion (Actual): April 1, 2007

Study Registration Dates

• First Submitted: April 23, 2006
• First Submitted That Met QC Criteria: April 23, 2006
• First Posted (Estimate): April 25, 2006

Study Record Updates

• Last Update Posted (Estimate): May 17, 2007
• Last Update Submitted That Met QC Criteria: May 16, 2007
• Last Verified: May 1, 2007

More Information

Terms related to this study

• Keywords: back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: Jointcare/Fe/1/DK; Eudractnr. 2005-002691-15