Effectiveness of salmon calcitonin nasal spray in the treatment of lumbar canal stenosis: a double-blind, randomized, placebo-controlled, parallel group trial.
METHODS
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.


BACKGROUND
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 > or =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). No significant 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.
Podichetty
Vinod K
VK
Spine Research & Education, Spine Institute, The Cleveland Clinic Florida, Weston, FL 33331, USA. podichv@ccf.org
Segal
Allen M
AM
Lieber
Michael
M
Mazanec
Daniel J
DJ
D000281:Administration, Intranasal; D000336:Aerosols; D000368:Aged; D000369:Aged, 80 and over; D002116:Calcitonin / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D013130:Spinal Stenosis / Q000188:drug therapy* / Q000523:psychology; D011795:Surveys and Questionnaires; D017211:Treatment Failure; D016138:Walking
D000336:Aerosols; C028815:salmon calcitonin; D002116:Calcitonin