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

Phase 4

Completed

• Conditions: Low Back Pain
• Interventions: Drug: Glucosamine sulphate; Drug: Placebo

• Registration Number: NCT00404079
• Lead Sponsor: Ullevaal University Hospital

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 available

Study Timeline

• Study First Submitted: 2006-11-23
• Study First Submitted QC: 2006-11-24
• Study First Posted: 2006-11-27
• Study Start: 2006-12
• Primary Completion: 2009-08
• Study Completion: 2010-11
• Status Verified: 2011-02
• Results First Submitted: 2011-02-21
• Results First Submitted QC: 2011-04-04
• Last Update Submitted: 2011-04-04
• Results First Posted: 2011-04-29
• Last Update Posted: 2011-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glucosamine Sulphate	Glucosamine sulphate	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Roland Morris Disability Questionnaire	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.

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale	1 year
EuroQol-5D	1 year

Trial Locations

Locations (1)

Ulleval Universtiy Hospital; 🇳🇴 Oslo, Norway