title: Botulinum Toxin Treatment for Nocturnal Calf Cramps in Patients With Lumbar Spinal Stenosis: A Randomized Clinical Trial.
abstract: To evaluate the clinical effectiveness of botulinum toxin (BTX) injection into the gastrocnemius muscles in patients with lumbar spinal stenosis (LSS) who have frequent nocturnal calf cramps (NCCs).
  
  
  
  Prospective, randomized clinical trial.
  
  
  
  Outpatient department for interventional pain management.
  
  
  
  Patients (N=50) with LSS who have NCCs at least once per week were enrolled.
  
  
  
  Patients were randomly allocated to receive either conservative treatments plus gabapentin (group GPN) or BTX injection (group BTX).
  
  
  
  We 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.
  
  
  
  Forty-five patients completed all assessments (group GPN, n=21; group BTX, n=24). Compared with group GPN, leg pain intensity, cramp frequency, and cramp severity were significantly decreased in group BTX at all follow-up visits (all, P<.01). Also, insomnia significantly improved in group BTX at the 2-week (P=.018) and 1-month follow-up (P=.037). Functional disability significantly improved in group BTX at 2 weeks' follow-up (P=.041). At the 3-month follow-up, patients in group BTX reported a higher impression of improvement for NCC symptoms than did those in group GPN (P<.001). A mean dose of 642.8mg of gabapentin was given daily in group GPN, but 7 patients (33.3%) reported systemic side effects. There were no serious complications related to BTX use.
  
  
  
  BTX treatment appears to be effective and safe for NCCs in symptomatic LSS patients receiving conservative care.
authors.affiliation: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Sang Jun
authors.initials: SJ
authors.lastname: Park
authors.affiliation: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Kyung Bong
authors.initials: KB
authors.lastname: Yoon
authors.affiliation: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Duck Mi
authors.initials: DM
authors.lastname: Yoon
authors.affiliation: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: tessar@yuhs.ac.
authors.forename: Shin Hyung
authors.initials: SH
authors.lastname: Kim
mesh_terms: D000368:Aged; D000588:Amines / Q000627:therapeutic use; D000700:Analgesics / Q000627:therapeutic use; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D003509:Cyclohexanecarboxylic Acids / Q000627:therapeutic use; D005260:Female; D000077206:Gabapentin; D006801:Humans; D008159:Lumbar Vertebrae; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000627:therapeutic use*; D059408:Pain Management; D062072:Patient Acuity; D011446:Prospective Studies; D020922:Sleep-Wake Transition Disorders / Q000188:drug therapy* / Q000209:etiology*; D013130:Spinal Stenosis / Q000150:complications*; D005680:gamma-Aminobutyric Acid / Q000627:therapeutic use
chemical_list: D000588:Amines; D000700:Analgesics; D003509:Cyclohexanecarboxylic Acids; D009465:Neuromuscular Agents; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin; D019274:Botulinum Toxins, Type A
keywords: Botulinum toxins; Muscle cramp; Rehabilitation; Spinal stenosis