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The Glucosamine-Study

This study has been completed.
Information provided by Ullevaal University Hospital

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

The Glucosamine-Study

Official Title ^†

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

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

Roland Morris Disability Questionnaire

Secondary Outcome Measure ^†

Visual Analogue Scale
EuroQol-5D

Condition ^†

Low Back Pain

Intervention ^†

Drug: Glucosamine sulphate

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

Completion Date

Eligibility 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

Gender

Both

Ages

25 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Norway

Administrative Information Fields

NCT ID ^†

NCT00404079

Organization ID

28130805

Secondary IDs ^††

Study Sponsor ^†

Ullevaal University Hospital

Collaborators ^††

Investigators ^†

Principal Investigator:

Oliver Grundnes, MD

Ullevaal University Hospital

Information Provided By

Ullevaal University Hospital

Verification Date

September 2006

First Received Date ^†

November 23, 2006

Last Updated Date

June 9, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.