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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014