Randomized DB Controlled Trial of Botulinum Toxin A in Hemiplegic Shoulder Pain and Spasticity

Summary

The purpose of this study is to evaluate whether botulinum toxin type A injected into muscles around the shoulder is effective in treating shoulder pain and improving function in patients with shoulder pain and involuntary muscle tightness after a stroke.

Timeline

Start

2003-09

Primary completion

2009-03

Completion

2010-02

Outcome

Mixed primary results

paper no significant differences between the groups found for any of the daily pain ratings (P's > 0.05). PMID 23064478 ↗

paper Significant improvement (P < 0.05) in change scores for hygiene on the Disability Assessment Scale was found in the botulinum toxin type A group PMID 23064478 ↗

paper in the botulinum toxin type A group compared with the placebo group at week 4 PMID 23064478 ↗

Publications

• Results Marciniak CM, Harvey RL, Gagnon CM, Duraski SA, Denby FA, McCarty S, Bravi LA, Polo KM, Fierstein KM. Does botulinum toxin type A decrease pain and lessen disability in hemiplegic survivors of stroke with shoulder pain and spasticity?: a randomized, double-blind, placebo-controlled trial. Am J Phys Med Rehabil. 2012 Dec;91(12):1007-19. doi: 10.1097/PHM.0b013e31826ecb02.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	100 iu	Intramuscular
Subject	Botulinum toxin type A	Protein / enzyme biologic	200 iu	Intramuscular

Indications

No indication recorded.