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


METHODS
Prospective, single-site, open-label trial.


METHODS
Rehabilitation medicine clinic in Seoul, Korea.


METHODS
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.


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 However, at 4 weeks, patients in the active control group were withdrawn from the study because their pain did not improve, and continuation without further medical care was considered unethical.


CONCLUSIONS
A low dose of botulinum toxin type A relieved pain and improved quality of life in patients with refractory piriformis syndrome.
Yoon
Se Jin
SJ
Department of Rehabilitation Medicine, Wooridul Spine Hospital, Seoul, Korea.
Ho
Jin
J
Kang
Ho Yeong
HY
Lee
Sang Ho
SH
Kim
Kyung Im
KI
Shin
Wan Gyoon
WG
Oh
Jung Mi
JM
D000328:Adult; D000779:Anesthetics, Local / Q000627:therapeutic use; D044466:Asian People; D019274:Botulinum Toxins, Type A / Q000009:adverse effects / Q000627:therapeutic use*; D003907:Dexamethasone / Q000627:therapeutic use; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D007723:Korea; D008012:Lidocaine / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009119:Muscle Contraction / Q000187:drug effects; D052580:Muscle Stretching Exercises; D018482:Muscle, Skeletal / Q000187:drug effects*; D009465:Neuromuscular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement; D011446:Prospective Studies; D011788:Quality of Life; D012047:Rehabilitation Centers; D012584:Sciatic Nerve / Q000503:physiopathology; D013577:Syndrome; D014057:Tomography, X-Ray Computed
D000779:Anesthetics, Local; D005938:Glucocorticoids; D009465:Neuromuscular Agents; D003907:Dexamethasone; D008012:Lidocaine; D019274:Botulinum Toxins, Type A