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

Study Overview
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Brief Summary
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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.

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

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: Glucosamine sulphate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucosamine Sulphate<br> | Drug: Glucosamine sulphate<br>* Oral intake of 1500 mg glucosamine sulfate(from Pharma Nord) daily for 6 months<br>* Other names: Glucosamine sulfata Pharma Nord;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral intake of 3 placebo capsules (similiar looking to the glucosamine sulfate capsules)daily for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale |  | 1 year | 
| EuroQol-5D |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic low back pain