Phase 4
N=250
The Glucosamine-study: The Effect of Glucosamine in Treatment of Chronic Low Back Pain
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT00404079 ↗Enrolled (actual)
250
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcome: Primary: Roland Morris Disability Questionnaire — 9; 9 units on a scale (0-24) — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Glucosamine sulphate (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Ullevaal University Hospital
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Roland Morris Disability Questionnaire |
9; 9 | 0.05 |
| SECONDARY Visual Analogue Scale |
— | — |
| SECONDARY EuroQol-5D |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT00404079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.