Is botulinum toxin type A effective in the treatment of spastic shoulder pain in patients after stroke? A double-blind randomized clinical trial

J Rehabil Med. 2007 Jul;39(6):440-7. doi: 10.2340/16501977-0066.


Objective: To determine the efficacy of botulinum toxin type A for the treatment of spastic shoulder pain in patients after stroke.

Design: Double-blind randomized clinical trial.

Patients: 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.

Conclusion: 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).

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Botulinum Toxins, Type A / administration & dosage
  • Botulinum Toxins, Type A / therapeutic use*
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Hemiplegia / complications
  • Hemiplegia / etiology
  • Hemiplegia / rehabilitation*
  • Humans
  • Injections, Intramuscular
  • Male
  • Middle Aged
  • Muscle Spasticity / drug therapy*
  • Muscle Spasticity / etiology
  • Neuromuscular Agents / administration & dosage
  • Neuromuscular Agents / therapeutic use*
  • Pain Measurement
  • Range of Motion, Articular
  • Shoulder Pain / drug therapy*
  • Shoulder Pain / etiology
  • Transcutaneous Electric Nerve Stimulation
  • Treatment Outcome


  • Neuromuscular Agents
  • Botulinum Toxins, Type A