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

NCT ID: NCT00404079

Last Updated: 2011-04-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-11-30

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.

Detailed Description

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Conditions

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Low Back Pain

Keywords

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Chronic low back pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Glucosamine Sulphate

Group Type EXPERIMENTAL

Glucosamine sulphate

Intervention Type DRUG

Oral intake of 1500 mg glucosamine sulfate(from Pharma Nord) daily for 6 months

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral intake of 3 placebo capsules (similiar looking to the glucosamine sulfate capsules)daily for 6 months

Interventions

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Glucosamine sulphate

Oral intake of 1500 mg glucosamine sulfate(from Pharma Nord) daily for 6 months

Intervention Type DRUG

Placebo

Oral intake of 3 placebo capsules (similiar looking to the glucosamine sulfate capsules)daily for 6 months

Intervention Type DRUG

Other Intervention Names

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Glucosamine sulfata Pharma Nord

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
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stiftelsen Helse og Rehabilitering

OTHER

Sponsor Role collaborator

Ullevaal University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ullevaal University Hospital

Principal Investigators

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Oliver Grundnes, MD

Role: PRINCIPAL_INVESTIGATOR

Ullevaal University Hospital

Locations

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Ulleval Universtiy Hospital

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 20606148 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22900984 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22718223 (View on PubMed)

Other Identifiers

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28130805

Identifier Type: -

Identifier Source: org_study_id