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

This study has been completed.
Sponsor:
Information provided by:
Ferrosan AS
ClinicalTrials.gov Identifier:
NCT00317655
First received: April 23, 2006
Last updated: May 16, 2007
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Back Pain
Drug: Glucosamine sulphate
Drug: Ginger
Drug: Ginger-Avocado-Soya
Drug: Ginger-ibuprofen
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Ferrosan AS:

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

Secondary Outcome Measures:
  • 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)

Enrollment: 175
Study Start Date: April 2006
Study Completion Date: April 2007
  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00317655

Locations
Denmark
Slidgigtinstituttet A/S
Ishoj, Denmark, 2635
Sponsors and Collaborators
Ferrosan AS
Investigators
Principal Investigator: Keld Østergaard, MD, PhD Slidgigtinstituttet A/S
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00317655     History of Changes
Other Study ID Numbers: Jointcare/Fe/1/DK, Eudractnr. 2005-002691-15
Study First Received: April 23, 2006
Last Updated: May 16, 2007
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Ferrosan AS:
back pain

Additional relevant MeSH terms:
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014