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Randomized Controlled Trial
Is botulinum toxin type A effective in the treatment of spastic shoulder pain in patients after stroke? A double-blind randomized clinical trial.
- Ester Marco, Esther Duarte, Joan Vila, Marta Tejero, Anna Guillen, Roser Boza, Ferran Escalada, and Josep M Espadaler.
- Physical Medicine and Rehabilitation Department, Hospital de l'Esperança, Sant Josep de la Muntanya, Barcelona, Spain.
- J Rehabil Med. 2007 Jul 1;39(6):440-7.
ObjectiveTo determine the efficacy of botulinum toxin type A for the treatment of spastic shoulder pain in patients after stroke.DesignDouble-blind randomized clinical trial.PatientsOf 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.MethodsAfter 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.ResultsThe 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.ConclusionPatients 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).
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