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

Abstract

BackgroundThe 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.ResultsOf 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).ConclusionsIn 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 registrationNCT00404079 at http://www.clinicaltrial.gov.

Short tau inversion recovery MRI of Modic changes: a reliability study

“…Such data were included in articles on spondylarthritis (1)(2)(3)(4)(5), fractures (6), Modic changes (MCs) (7), hemangiomas (8), and pedicle screw loosening (9). However, all but one (6) of these reliability studies had only two observers, most (1,3-5,7-9) had small patient samples (n ¼ [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41], only one (8) included measurements (of signal intensities); the spondylarthritis studies were limited to lesion detection (1)(2)(3)(4)(5). Reliability estimates differed widely in these heterogeneous studies where radiologists and non-radiologists interpreted various fat-suppressed 1.5-T or 3-T series.…”

Glucosamine Dose/Concentration-Effect Correlation in the Rat with Adjuvant Arthritis

“…This mater raises the question that whether bioavailability of GlcN form different formulations is responsible for the discrepancy between the outcomes of various clinical trials, or patients are underdosed when treated with the common 1500 mg/day regimen. Surprisingly, after many clinical trials, which reported no or marginal effects for 1500 mg/day GlcN in OA, the subsequent studies [15][16][17][18][19] still have used the same regimen with no attempt to try a greater daily dose. To the best of our knowledge, no information is available as to the GlcN minimum effective dose or concentration in animals or human.…”

Disc size markedly influences concentration profiles of intravenously administered solutes in the intervertebral disc: a computational study on glucosamine as a model solute

“…Moreover, the discs have no free surface in contact with synovial fluid and when small molecules such as GL are injected intravenously into the blood stream, they diffuse from blood vessels at the endplates and outer annulus periphery into discs with the transport being affected by pathological alterations to these pathways. Nevertheless, there is some interest in use of GL for treatment of back pain and disc degeneration [23,24].…”