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The Glucosamine-study: The Effect of Glucosamine in Treatment of Chronic Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00404079
Recruitment Status : Completed
First Posted : November 27, 2006
Results First Posted : April 29, 2011
Last Update Posted : April 29, 2011
Sponsor:
Collaborator:
Stiftelsen Helse og Rehabilitering
Information provided by:
Oslo University Hospital

Study Description
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Brief Summary:

Low back pain (LBP) is the most frequent cause of sick leave and disability pension, and degenerative and osteoarthritic (OA) changes is a significant cause of pain and disability. Some indications exist for symptomatic and possible cartilage-structurmodifying effect on knee- and hip-osteoarthritis with glucosamine sulphate (GS). The OA process in the lumbar spine is most likely to OA processes in knees and hips, hence GS could have comparable symptomatic and structural effect on lumbar OA.

Study hypothesis: No difference in treatment effect exists between oral intake of GS- or placebo-capsules for patients' with chronic low back pain measured with Roland Morris Disability Questionnaire.


Condition or disease Intervention/treatment Phase
Low Back Pain Drug: Glucosamine sulphate Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Glucosamine Sulphate in the Treatment for Chronic Low Back Pain Patients With Degenerative Lumbar MRI Findings
Study Start Date : December 2006
Actual Primary Completion Date : August 2009
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Glucosamine Sulphate Drug: Glucosamine sulphate
Oral intake of 1500 mg glucosamine sulfate(from Pharma Nord) daily for 6 months
Other Name: Glucosamine sulfata Pharma Nord
Placebo Comparator: Placebo Drug: Placebo
Oral intake of 3 placebo capsules (similiar looking to the glucosamine sulfate capsules)daily for 6 months


Outcome Measures
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Primary Outcome Measures :
  1. Roland Morris Disability Questionnaire [ Time Frame: 1 year ]
    The primary outcome was scores on the Norwegian version of Roland Morris Disability Questionnaire (RMDQ). RMDQ is a widely used back-specific, self-administered measure of pain-related disability. Greater levels of disability give higher numbers on a 24-point scale. RMDQ has content and construct validity and internal consistency. It is also reproducible and sensitive to change over time for LBP patients. A 3-point reduction in the total RMDQ was a priori classified as a response to treatment.


Secondary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: 1 year ]
  2. EuroQol-5D [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Low back pain for more than 6 months
  • Patient older than 25 years old
  • MRI findings comparable with lumbar degenerative/osteoarthritic changes.

Exclusion Criteria:

  • Spinal stenosis with neurological deficits
  • Spinal prolapse with neurological deficits
  • Rheumatoid arthritis, psoriatic arthritis,
  • Old lumbar fractures
  • Chronic pain syndromes (e.g. fibromyalgia)
  • Psychosocial status not suitable for participation
  • Pregnancy
  • Breastfeeding
  • Allergic to shellfish
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404079


Locations
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Norway
Ulleval Universtiy Hospital
Oslo, Norway, 0450
Sponsors and Collaborators
Ullevaal University Hospital
Stiftelsen Helse og Rehabilitering
Investigators
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Principal Investigator: Oliver Grundnes, MD Ullevaal University Hospital
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Oliver Grundnes, Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00404079    
Other Study ID Numbers: 28130805
First Posted: November 27, 2006    Key Record Dates
Results First Posted: April 29, 2011
Last Update Posted: April 29, 2011
Last Verified: February 2011
Keywords provided by Oslo University Hospital:
Chronic low back pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations