RANDOMISED DOUBLE BLINDED PLACEBO-CONTROLLED TRIAL ON THE EFFECTIVENESS OF NASAL SALMON CALCITONIN IN THE TREATMENT OF LUMBAR SPINAL STENOSIS

Abstract

Purpose: To assess the effectiveness of nasal salmon cal-citonin in the treatment of lumbar spinal stenosis

Methods: Forty patients with symptoms of neurogenic claudication and MRI proven lumbar spinal stenosis were enrolled into the study. They were randomly assigned to either nasal salmon calcitonin 200 i.u or placebo nasal spray (sodium chloride) for the first 4 weeks. At the end of the 4 weeks of initial treatment the patients were given a 6 weeks washout period, during which they received no further nasal spray and were instructed to continue with their normal analgesics. At the end of this period all patients received a further 6 weeks of active nasal salmon calcitonin.

Outcome measures: Oswestry Disability Index (ODI), Low Back Outcome Score (LBOS), Visual Analogue Score (VAS) for leg and back pain, Shuttle Walking Test Distance in metres.

Results: In the 4 weeks during which patients received active/placebo nasal salmon calcitonin there was no statistically significant difference in the change in outcome scores between the two groups (change in ODI [p=0.51], change in VAS for leg pain [p=0.51] and change in shuttle walking distance [p=0.78]) There is a minimal improvement in the mean ODI at the end of only 3.7 points in the calcitonin group and 3.8 points in the placebo group [p=0.44]. The VAS for leg pain deteriorated in both groups. There was a minimal improvement in the VAS for back pain in the calcitonin group of 5 mm, it deteriorated in the placebo group by 11mm [p=0.03]. At the end of the trial 9 patients (23%) reported either an excellent or good outcome, 6 reported a fair outcome (15%) and 17 patients (43%) reported a poor outcome.

Conclusion: This dose of Nasal salmon calcitonin is not effective in the treatment of patients with lumbar spinal stenosis.