The Glucosamine-Study: The Effect of Glucosamine in Treatment of Chronic Low Back Pain - Tabular View

Tracking Information

First Received Date ^ICMJE

November 23, 2006

Last Updated Date

May 11, 2009

Start Date ^ICMJE

December 2006

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Roland Morris Disability Questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Roland Morris Disability Questionnaire

Change History

Complete list of historical versions of study NCT00404079 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Visual Analogue Scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
EuroQol-5D [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Visual Analogue Scale
EuroQol-5D

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Low Back Pain

Intervention ^ICMJE

Drug: Glucosamine sulphate
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

250

Estimated Completion Date

August 2009

Estimated 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

Gender

Both

Ages

25 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00404079

Responsible Party

Dr. Oliver Grundnes, Ullevaal University Hospital

Study ID Numbers ^ICMJE

28130805

Study Sponsor ^ICMJE

Ullevaal University Hospital

Collaborators ^ICMJE

Helse og rehabilitering

Investigators ^ICMJE

Principal Investigator:

Oliver Grundnes, MD

Ullevaal University Hospital

Information Provided By

Ullevaal University Hospital

Verification Date

September 2006

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