Is botulinum toxin type A effective in the treatment of spastic shoulder pain in patients after stroke? A double-blind randomized clinical trial.
OBJECTIVE
To determine the efficacy of botulinum toxin type A for the treatment of spastic shoulder pain in patients after stroke.


METHODS
Double-blind randomized clinical trial.


METHODS
Of 31 patients enrolled from an acute-care hospital in Spain, 2 cases dropped out (drop-out rate 6.5%). Fourteen subjects were treated with infiltration of 500 units of botulinum toxin type A in the pectoralis major muscle of the paretic side, and 15 with a placebo.


METHODS
After infiltration, both groups received transcutaneous electrical nerve stimulation for 6 weeks. Patients were assessed by the use of the Visual Analogue Scale for pain. A good result concerning pain was considered when the Visual Analogue Scale score was below 33.3 mm or less than half the initial score. The patients were followed-up for 6 months.


RESULTS
The patients treated with botulinum toxin type A showed a significantly greater pain improvement from the first week post-infiltration. Persistent shoulder pain was observed more frequently in the placebo group, with relative risks in the range 0.32-0.41 during the follow-up period.


CONCLUSIONS
Patients with spastic shoulder pain treated with a botulinum toxin type A infiltration in the pectoralis major muscle of the paretic side have a higher likelihood of pain relief (between 2.43- and 3.11-fold).
Marco
Ester
E
Physical Medicine and Rehabilitation Department, Hospital de l'Esperança, Sant Josep de la Muntanya, Barcelona, Spain.
Duarte
Esther
E
Vila
Joan
J
Tejero
Marta
M
Guillen
Anna
A
Boza
Roser
R
Escalada
Ferran
F
Espadaler
Josep M
JM
D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006429:Hemiplegia / Q000150:complications / Q000209:etiology / Q000534:rehabilitation*; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology; D009465:Neuromuscular Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D010147:Pain Measurement; D016059:Range of Motion, Articular; D020069:Shoulder Pain / Q000188:drug therapy* / Q000209:etiology; D004561:Transcutaneous Electric Nerve Stimulation; D016896:Treatment Outcome
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A