Study Design. Double-blind, randomized, placebo-controlled study to assess the effectiveness of calcitonin nasal spray on symptoms and function in patients with lumbar canal stenosis.
Objective. To compare effectiveness of calcitonin administered by nasal spray with placebo in patients with clinically symptomatic lumbar canal stenosis.
Summary of Background Data. Lumbar canal stenosis is the most common reason for spine surgery in individuals over 65 years of age. Nonoperative approaches have been not well studied and limited primarily to physical therapy exercises. Several small trials in the past have suggested that subcutaneous and intramuscular calcitonin is an effective nonsurgical option in treating the symptoms of spinal stenosis patients. Only three trials were randomized and placebo-controlled.
Methods. Fifty-five patients with clinical lumbar canal stenosis (pseudoclaudication), confirmatory MR imaging, and pain intensity index (VAS) of ≥6 were randomized to either placebo or intranasal calcitonin daily for 6 weeks, followed by an open label 6-week extension, during which all patients received active drug. Outcome parameters performed at baseline, 6 weeks, and 12 weeks, included pain intensity index, walking time and distance to pain, SF-36, and Oswestry disability index.
Results. Thirty-six patients received calcitonin, and 19 placebo. Eight (14.54%) calcitonin and 4 (7.27%) placebo patients withdrew from the study. The mean baseline pain score for calcitonin group was 7.8 and 7.5 for placebo. Comparisons at week 6 showed no statistically significant difference in the change in pain intensity (VAS) between calcitonin group (−2.9) and placebo (−2.4) (P = 0.4382) from baseline. There was no significant difference in walking time to pain (calcitonin −10.0 seconds; placebo +32.2 seconds; P = 0.5136). Walking distance to pain showed a mean improvement of +91.4 ft in the calcitonin group and +254.7 ft in the placebo group (P = 0.4948). Nosignificant difference was observed in the SF-36 score between the treatment groups. Using a threshold of at least 50% reduction in pain from baseline to 6 weeks, 12 of 29 (41.37%) of calcitonin patients were considered responders versus 7 of 18 (38.88%) of placebo patients (P = 0.4238)
Conclusions. In this first ever largest randomized placebo-controlled parallel group trial of nasal calcitonin in spinal stenosis, nasal calcitonin was not superior to placebo in treating the symptoms of spinal stenosis at 6 weeks. Based on this study, nasal calcitonin does not appear to have a role in nonoperative treatment of lumbar canal stenosis.
A prospective randomized pilot study of calcitonin nasal spray was performed in patients with lumbar canal stenosis and outcome parameters assessed. Calcitonin was not superior to placebo in treating the symptoms of lumbar canal stenosis.
From the *Spine Research & Education, Spine Institute, The Cleveland Clinic Florida, Weston, FL; and †Spine Center and ‡Department of Biostatistics & Epidemiology, the Cleveland Clinic Foundation, Cleveland, OH.
Acknowledgment date: November 27, 2002. First revision date: March 5, 2003. Second revision date: July 21, 2003. Third revision date: October 22, 2003. Acceptance date: December 11, 2003.
Supported by Novartis Pharmaceuticals, New Jersey.
Accepted as an abstract at ISSLS 30th Annual Meeting, Vancouver, Canada, May 13–17, 2003, and NASS Spine Across the Sea Meeting, Maui, Hawaii, July 27–31, 2003.
The device(s)/drug(s) that is/are the subject of this manuscript is/are not FDA-approved for this indication and is/are not commercially available in the United States.
Corporate/Industry funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.
Address correspondence and reprint requests to Vinod K. Podichetty, MD, MS, Project Director, Spine Research & Education, Spine Institute, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd., Weston FL 33331; E-mail: email@example.com