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Low-dose botulinum toxin type A for the treatment of refractory piriformis syndrome.

AbstractSTUDY OBJECTIVES:
To evaluate the efficacy of a single, low-dose injection of botulinum toxin type A in relieving pain in Korean patients with piriformis syndrome resistant to conventional therapy, and to assess the drug's influence on these patients' quality of life.
DESIGN:
Prospective, single-site, open-label trial.
SETTING:
Rehabilitation medicine clinic in Seoul, Korea.
PATIENTS:
Twenty-nine patients with a confirmed diagnosis of chronic piriformis syndrome and 82 age- and sex-matched healthy subjects were enrolled from April 1, 2003-February 28, 2004. Intervention. In 20 of the patients, botulinum toxin type A 150 U was injected using computed tomographic guidance into the affected unilateral piriformis muscle. The other nine patients served as active controls and received an injection of dexamethasone 5 mg and 1% lidocaine. The healthy subjects did not receive any injection.
MEASUREMENTS AND MAIN RESULTS:
The patients' pain at baseline and at 4, 8, and 12 weeks after treatment was rated by using a numeric rating scale. Health-related quality of life was assessed by using the validated Korean version of the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) at baseline and at 4 weeks of treatment. Healthy subjects also completed the SF-36 at baseline. Pain intensity scores were significantly lower at 4, 8, and 12 weeks after treatment than at baseline (p<0.0001). Baseline scores from the SF-36 subscales, including those for physical functioning (p<0.0001), role physical (p<0.0001), bodily pain (p<0.0001), general health (p<0.0001), vitality (p<0.0001), and social functioning (p<0.002), were significantly lower in the patients than in the healthy subjects. Four weeks after treatment, physical functioning (p=0.003), role physical (p=0.021), bodily pain (p=0.016), general health (p=0.013), vitality (p=0.031) and social functioning (p=0.035) improved significantly from baseline in the patients. However, at 4 weeks, patients in the active control group were withdrawn from the study because their pain did not improve, and continuation without further medical care was considered unethical.
CONCLUSION:
A low dose of botulinum toxin type A relieved pain and improved quality of life in patients with refractory piriformis syndrome.
AuthorsSe Jin Yoon, Jin Ho, Ho Yeong Kang, Sang Ho Lee, Kyung Im Kim, Wan Gyoon Shin, Jung Mi Oh
JournalPharmacotherapy (Pharmacotherapy) Vol. 27 Issue 5 Pg. 657-65 (May 2007) ISSN: 0277-0008 [Print] United States
PMID17461700 (Publication Type: Clinical Trial, Comparative Study, Journal Article)
Chemical References
  • Anesthetics, Local
  • Glucocorticoids
  • Neuromuscular Agents
  • Dexamethasone
  • Lidocaine
  • Botulinum Toxins, Type A
Topics
  • Adult
  • Anesthetics, Local (therapeutic use)
  • Asian People
  • Botulinum Toxins, Type A (adverse effects, therapeutic use)
  • Dexamethasone (therapeutic use)
  • Female
  • Glucocorticoids (therapeutic use)
  • Humans
  • Korea
  • Lidocaine (therapeutic use)
  • Male
  • Middle Aged
  • Muscle Contraction (drug effects)
  • Muscle Stretching Exercises
  • Muscle, Skeletal (drug effects)
  • Neuromuscular Agents (adverse effects, therapeutic use)
  • Pain (drug therapy)
  • Pain Measurement
  • Prospective Studies
  • Quality of Life
  • Rehabilitation Centers
  • Sciatic Nerve (physiopathology)
  • Syndrome
  • Tomography, X-Ray Computed

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