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

Low Back Pain Clinical Trial

Official title:

Phase 4 Study of Glucosamine Sulphate in the Treatment for Chronic Low Back Pain Patients With Degenerative Lumbar MRI Findings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404079
• Other study ID #: 28130805
• Status: Completed
• Phase: Phase 4
• First received: November 23, 2006
• Last updated: April 4, 2011
• Start date: December 2006
• Est. completion date: November 2010

Study information

• Verified date: February 2011
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: November 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Glucosamine sulphate
Oral intake of 1500 mg glucosamine sulfate(from Pharma Nord) daily for 6 months
• Placebo
Oral intake of 3 placebo capsules (similiar looking to the glucosamine sulfate capsules)daily for 6 months

Locations

Country	Name	City	State
Norway	Ulleval Universtiy Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Ullevaal University Hospital	Stiftelsen Helse og Rehabilitering

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. doi: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Roland Morris Disability Questionnaire	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.	1 year	No
Secondary	Visual Analogue Scale		1 year	No
Secondary	EuroQol-5D		1 year	No