The Glucosamine-Study

Condition(s) targeted: Low Back Pain

Intervention: Glucosamine sulphate (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Ullevaal University Hospital

Official(s) and/or principal investigator(s):
Oliver Grundnes, MD, Principal Investigator, Affiliation: Ullevaal University Hospital

Overall contact:
Philip Wilkens, M Chiro, Phone: 004723016140, Email: wiph@uus.no

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

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Roland Morris Disability Questionnaire

Secondary outcome:

Visual Analogue Scale

EuroQol-5D

Minimum age: 25 Years. Gender(s): Both.

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

Philip Wilkens, M Chiro, Phone: 004723016140, Email: wiph@uus.no

Ulleval Universtiy Hospital, Oslo 0450, Norway; Recruiting
Philip Wilkens, M Chiro, Phone: 004723016140, Email: wiph@uus.no

Last updated: April 20, 2007