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

Ullevaal University Hospital

Status and phase: Completed; Phase 4

Conditions: Low Back Pain

Treatments: Drug: Glucosamine sulphate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00404079

28130805

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 2 patient groups, including a placebo group

Glucosamine Sulphate

Experimental group

Treatment:

Drug: Glucosamine sulphate

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo