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

This study has been completed.
Sponsor:
Collaborator:
Stiftelsen Helse og Rehabilitering
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00404079
First received: November 23, 2006
Last updated: April 4, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Low Back Pain
Drug: Glucosamine sulphate
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Roland Morris Disability Questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Visual Analogue Scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • EuroQol-5D [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: December 2006
Study Completion Date: November 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
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
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: NCT00404079

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Oliver Grundnes, Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00404079     History of Changes
Other Study ID Numbers: 28130805
Study First Received: November 23, 2006
Results First Received: February 21, 2011
Last Updated: April 4, 2011
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
Chronic low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014