Use of Botulinum Toxin as a Treatment of Hemiplegic Shoulder Pain Syndrome: A Randomized Trial

Objective: The primary objective of this paper is to assess whether the use of 200 units of abobotulinum in the pectoralis major and subscapularis muscles modifies the pain complaint assessed using the visual analog scale in subjects with shoulder pain after the onset of spastic hemiplegia due to cerebrovascular disease when compared to the application of a placebo to the same muscles. Design: A prospective, double-blind, randomized, and placebo-controlled clinical trial study in two different rehabilitation centers. Setting: Two distinct outpatient neurological rehabilitation services. Participants: Patients older than 18 years who were included presented upper limb spasticity resulting from ischemic or hemorrhagic stroke and a diagnosis of Painful Hemiplegic Shoulder Syndrome (PHSS) that was independent of motor dominance. Interventions: Patients were divided into two groups, one of them underwent the application of botulinum toxin (TXB-A) in the pectoralis major and subscapularis muscles, at a total dose of 400 U. Main Outcome Measure: Patients were assessed for a change in pain using the Visual Analog Scale (VAS) for at least 13 mm. Results: An improvement in pain and spasticity levels in both groups, more intense in the toxin group, but without statistical significance. The comparison between the groups showed a reduction in pain by VAS (p = 0.52). Conclusions: The use of botulinum toxin in the subscapularis and pectoralis major muscles resulted in a reduction in shoulder pain in spastic hemiplegic patients without statistical significance.