Randomised placebo-controlled trial on the effectiveness of nasal salmon calcitonin in the treatment of lumbar spinal stenosis

Abstract

This is a double blind randomised controlled trial to assess the effectiveness of nasal salmon calcitonin in the treatment of lumbar spinal stenosis. The trial compared the outcome of salmon calcitonin nasal spray to placebo nasal spray in patients with MRI confirmed lumbar spinal stenosis. Lumbar spinal stenosis is one of the commonest conditions encountered by spine surgeons. It more frequently affects elderly patients and lumbar decompression has been used to treat the condition with variable success. Non operative measures have been investigated, but their success ranges from 15% to 43% in patients followed up for 1-5 years (Simotas in Clin Orthop 1(384): [153][154][155][156][157][158][159][160][161] 2001). Salmon calcitonin injections have been investigated in previous trials and may have a treatment effect. Nasal salmon calcitonin has become available and if effective would have advantages over injections. Forty patients with symptoms of neurogenic claudication and MRI proven lumbar spinal stenosis were randomly assigned either nasal salmon calcitonin or placebo nasal spray to use for 4 weeks. This was followed by a 'washout' period of 6 weeks, and subsequent treatment with 6 weeks of nasal salmon calcitonin. Standard spine outcome measures including Oswestry disability index (ODI), low back outcome score, visual analogue score and shuttle walking test were administered at baseline, 4, 10 and 16 weeks. Twenty patients received nasal salmon calcitonin and twenty patients received placebo nasal spray. At 4 weeks post treatment there was no statistically significant difference in the outcome measures between the two groups. The change in ODI was a mean 1.3 points for the calcitonin group and 0.6 points for the placebo group (P = 0.51), the mean change in visual analogue score for leg pain was 10 mm in the calcitonin group and 0 mm in the placebo group (P = 0.51). There was no significant difference in walking distance between the two groups, with a mean improvement in walking distance of 21 m in the calcitonin group and 8 m in the placebo group (P = 0.78). At the end of the trial the ODI had improved by a mean of 3.7 points in the calcitonin group and 3.8 points in the placebo group (P = 0.44). This randomised placebo controlled trial has not shown any treatment effect in patients with lumbar spinal stenosis treated with nasal salmon calcitonin.

Lumbar Spinal Stenosis

“…An old randomized cross-over trial of low methodological quality found a positive effect of intramuscular calcitonin(52), but two more recent studies using intranasal calcitonin could not replicate the findings. (53, 54) In patients with neurogenic claudication and imaging confirmed LSS, the addition of gabapentin to standard therapy (NSAIDs, physical therapy and steel bracing) was superior to placebo both in terms of pain sensory disturbances and walking distance. (55) In subgroup analysis the effect was mainly observed in patients with mild symptoms.…”

Variation in Eligibility Criteria From Studies of Radiculopathy due to a Herniated Disc and of Neurogenic Claudication due to Lumbar Spinal Stenosis

“…In addition, the definition of radiological LSS varied among studies. Some mentioned dural sac compression 16, while others referred to precise measurement of the lumbar canal 17. Congruence between radiating pain pattern and the radiological level of stenosis was mentioned once.…”

Pharmacotherapy of low back pain: targeting nociceptive and neuropathic pain components

“…No serious AEs were reported 111 . In a second randomized controlled trial in lumbar spinal stenosis, a nasal preparation of salmon calcitonin failed to show any significant benefit over placebo in terms of the Oswestry Disability Index score, VAS for leg pain, and walking distance 112 . In patients with degenerative lumbar spinal stenosis (n ¼ 152), methylcobalamin (a form of vitamin B12) 0.5 mg three times daily plus conventional management did not yield any additional improvement in pain or in neurological signs compared with conventional management alone (with the exception of neurogenic claudication, which was significantly improved in the active treatment group) 113 .…”