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

Sponsor:	Ullevaal University Hospital
Collaborator:	Stiftelsen Helse og Rehabilitering
Information provided by:	Oslo University Hospital
ClinicalTrials.gov Identifier:	NCT00404079

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 IV

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:

MedlinePlus related topics: Back Pain

Drug Information available for: Glucosamine hydrochloride Glucosamine sulfate Glucosamine

U.S. FDA Resources

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

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:

Wilkens P, Scheel IB, Grundnes O, Hellum C, Storheim K. Effect of glucosamine on pain-related disability in patients with chronic low back pain and degenerative lumbar osteoarthritis: a randomized controlled trial. JAMA. 2010 Jul 7;304(1):45-52.

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
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 12, 2012