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

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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

Tracking Information
First Submitted Date  ICMJE November 23, 2006
First Posted Date  ICMJE November 27, 2006
Results First Submitted Date  ICMJE February 21, 2011
Results First Posted Date  ICMJE April 29, 2011
Last Update Posted Date April 29, 2011
Study Start Date  ICMJE December 2006
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 24, 2006)
Roland Morris Disability Questionnaire
Change History Complete list of historical versions of study NCT00404079 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2009)
  • Visual Analogue Scale [ Time Frame: 1 year ]
  • EuroQol-5D [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2006)
  • Visual Analogue Scale
  • EuroQol-5D
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Glucosamine-study: The Effect of Glucosamine in Treatment of Chronic Low Back Pain
Official Title  ICMJE Phase 4 Study of Glucosamine Sulphate in the Treatment for Chronic Low Back Pain Patients With Degenerative Lumbar MRI Findings
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Drug: Glucosamine sulphate
    Oral intake of 1500 mg glucosamine sulfate(from Pharma Nord) daily for 6 months
    Other Name: Glucosamine sulfata Pharma Nord
  • Drug: Placebo
    Oral intake of 3 placebo capsules (similiar looking to the glucosamine sulfate capsules)daily for 6 months
Study Arms  ICMJE
  • Experimental: Glucosamine Sulphate
    Intervention: Drug: Glucosamine sulphate
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2009)
250
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00404079
Other Study ID Numbers  ICMJE 28130805
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Oliver Grundnes, Ullevaal University Hospital
Study Sponsor  ICMJE Ullevaal University Hospital
Collaborators  ICMJE Stiftelsen Helse og Rehabilitering
Investigators  ICMJE
Principal Investigator: Oliver Grundnes, MD Ullevaal University Hospital
PRS Account Oslo University Hospital
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP