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

NCT00404079 | Completed Phase 4 Results DMC

• 1 other identifier: 28130805
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Chronic low back pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Visual Analogue Scale

  1 year

• EuroQol-5D

  1 year

Study Arms (2)

Glucosamine Sulphate

EXPERIMENTAL

Drug: Glucosamine sulphate

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Glucosamine sulphate DRUG

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

Also known as: Glucosamine sulfata Pharma Nord

Glucosamine Sulphate

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Low back pain for more than 6 months
• Patient older than 25 years old
• MRI findings comparable with lumbar degenerative/osteoarthritic changes.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ullevaal University Hospital: lead
• Stiftelsen Helse og Rehabilitering: collaborator

Study Sites (1)

Ulleval Universtiy Hospital

Oslo, Oslo County, 0450, Norway

Location

Related Publications (3)

• 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.

  PMID: 20606148 RESULT

• 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.

  PMID: 22900984 DERIVED

• 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.

  PMID: 22718223 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Glucosamine

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexosamines; Amino Sugars; Carbohydrates

Limitations and Caveats

Free participation and the focus on glucosamine may attract a certain type of patients with specific personality traits. Adjunctive management was permitted, which may influence outcome. Compliance was assessed by capsule counts.

Results Point of Contact

• Title: Project Manager: Philip Wilkens
• Organization: Oslo University Hospital Ullevaal

philip.wilkens@medisin.uio.no

004723016140

Study Officials

• Oliver Grundnes, MD

  Ullevaal University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 23, 2006
• First Posted: November 27, 2006
• Study Start: December 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: November 1, 2010
• Last Updated: April 29, 2011
• Results First Posted: April 29, 2011

Record last verified: 2011-02

Locations

NO (1)