Clinical trial NCT00404079: The Glucosamine-study: The Effect of Glucosamine in Treatment of Chronic Low Back Pain
Official title: Phase 4 Study of Glucosamine Sulphate in the Treatment for Chronic Low Back Pain Patients With Degenerative Lumbar MRI Findings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Back Pain
Keywords: Chronic low back pain
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Stiftelsen Helse og Rehabilitering
First posted: 2006-11-27
Enrollment: 250
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Roland Morris Disability Questionnaire
timeFrame: 1 year
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: 1 year
measure: EuroQol-5D
timeFrame: 1 year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ulleval Universtiy Hospital
Study officials:
affiliation: Ullevaal University Hospital
name: Oliver Grundnes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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: 10.1001/jama.2010.893.
citation: Wilkens P, Storheim K, Scheel I, Berg L, Espeland A. No effect of 6-month intake of glucosamine sulfate on Modic changes or high intensity zones in the lumbar spine: sub-group analysis of a randomized controlled trial. J Negat Results Biomed. 2012 Aug 17;11:13. doi: 10.1186/1477-5751-11-13.
citation: Wilkens P, Scheel IB, Grundnes O, Hellum C, Storheim K. Prognostic factors of prolonged disability in patients with chronic low back pain and lumbar degeneration in primary care: a cohort study. Spine (Phila Pa 1976). 2013 Jan 1;38(1):65-74. doi: 10.1097/BRS.0b013e318263bb7b.