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Open Access Research

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

Philip Wilkens123*, Kjersti Storheim234, Inger Scheel25, Linda Berg67 and Ansgar Espeland67

Author Affiliations

1 Department of Orthopaedics, Oslo University Hospital, FOU, OS, BD, Bygg 73, Kirkeveien 166, 0460 Oslo, Norway

2 Department of Orthopaedics, University of Oslo, Kirkeveien 166, 0450 Oslo, Norway

3 Norwegian Research Centre for Active Rehabilitation (NAR), Hjelp24 NIMI, Pb. 3843 Ullevål Stadion, Sognsveien 75 D, 0805 Oslo, Norway

4 Communication- and Research Unit for Musculoskeletal Disorders, FORMI, Oslo University Hospital, Ullevål, Building 37b, 0407 Oslo, Norway

5 Norwegian Knowledge Centre for the Health Services, PO Box 7004 St. Olav’s plass, 0130 Oslo, Norway

6 Department of Radiology, Haukeland University Hospital, Jonas Lies vei 65, 5021 Bergen, Norway

7 Section for Radiology, Department of Surgical Sciences, University of Bergen, Jonas Lies vei 65, 5021, Bergen, Norway

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Journal of Negative Results in BioMedicine 2012, 11:13  doi:10.1186/1477-5751-11-13

Published: 17 August 2012

Abstract

Background

The underlying pathology and natural course of Modic changes (MC) in the vertebral body marrow and high intensity zones (HIZs) in the annulus fibrosus is not completely clarified. These findings on magnetic resonance imaging (MRI) have initiated different treatments with little or unclear effect. In a randomized trial (n = 250), glucosamine sulfate (GS) had no effect on low back pain related disability. GS could still have an effect on MC and HIZ. In this sub-study, 45 patients from the trial who had MC and/or HIZ at pre-treatment underwent follow-up MRI. The aim was to examine the course of MC and HIZ and to compare this course between groups treated with 6-month intake of oral GS versus placebo.

Results

Of 141 pre-treatment MC in 42 (of 45) patients, 29 (20.6%) MC in 18 patients had altered type and 14 MC in 9 patients had altered size (decreased for 1 MC) 6-18 months later: odds ratio (OR) for type vs. size alterations 4.0; 95% confidence interval (CI) 1.2-17.7. No MC resolved. HIZ vanished from 3 of 23 discs in 3 of 21 patients with pre-treatment HIZ. Ten new MC (all type I or I/II) occurred in 8 patients and 2 new HIZs in 2 patients. The GS group (n = 19) and placebo group (n = 26) did not differ in proportions of MC with decreased (OR 1.6; 95% CI 0.4-6.1) or increased type I dominance at follow-up (OR placebo:GS 2.4; 95% CI 0.6-9.7), or with increased size (OR 1.0; 95% CI 0.2-4.7). HIZ vanished from 1 of 8 discs in 1 of 8 patients in the GS group vs. 2 of 15 discs in 2 of 13 patients in the placebo group (OR 0.8; 95% CI 0.02-12.2).

Conclusions

In this sub-group analysis of a placebo-controlled trial, the effect of GS on MC and HIZs was no different from the effect of the placebo intervention. MC and HIZs remained mostly unchanged during the 6-18 months study period. Some short term changes did occur and MC more often altered type than size.

Trial registration

NCT00404079 at http://www.clinicaltrial.gov webcite.

Keywords:
Glucosamine sulfate; High intensity zone; Low back pain; Lumbar spine; Magnetic resonance imaging; Modic changes; Randomized trial; Treatment effect