Botulinum toxin treatment for nocturnal calf cramps in patients with lumbar spinal stenosis: A randomized clinical trial

Publication date: Available online 14 February 2017
Source:Archives of Physical Medicine and Rehabilitation
Author(s): Sang Jun Park, Kyung Bong Yoon, Duck Mi Yoon, Shin Hyung Kim
ObjectivesTo evaluate the clinical effectiveness of botulinum toxin (BTX) injection into the gastrocnemius muscles in lumbar spinal stenosis (LSS) patients with frequent nocturnal calf cramps (NCCs)DesignProspective randomized clinical trialSettingOutpatient department for interventional pain management.ParticipantsFifty LSS patients with a frequency of NCCs ≥ once per week were enrolled.InterventionPatients were randomly allocated to receive either conservative treatments plus gabapentin (Group GPN) or BTX injection (Group BTX).Main outcome measuresWe assessed back/leg pain intensity, the frequency and severity of NCCs, insomnia severity, and functional disability at baseline and after 2 weeks, 1 month, and 3 months. Additionally, patient global impression of change was assessed.ResultsForty-five patients completed all assessments (Group GPN; n=21, Group BTX; n=24). Compared with Group GPN, leg pain intensity, cramp frequency and severity were significantly decreased in Group BTX at all follow-up visits (all, p<0.01). Also, insomnia significantly improved in Group BTX at 2 weeks (p=0.018) and 1 month follow-up (p=0.037). Functional disability significantly improved in Group BTX at 2 weeks follow-up (p=0.041). At the 3 month follow-up, patients in Group BTX reported higher impression of improvement for NCCs symptoms than those in Group GPN (p<0.001). A mean dose of 642.8 mg gabapentin was given daily in Group GPN, but seven patients (33.3%) reported systemic side effects. There were no serious complications related to BTX use.ConclusionsBTX treatment appears to be effective and safe for NCCs in symptomatic LSS patients receiving conservative care.



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