The Therapeutic Use of Botulinum Toxin Type A in Subacute Cervical/Upper Back Pain

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the therapeutic efficacy of Botox not only for chronic cervical/upper back pain but also for subacute pain.

• Phase: N/A

Details

• Lead Sponsor: Palo Alto Veterans Institute for Research
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Male or female 18 y/o or greater,

• Subacute bilateral cervical/ upper back pain, pain of longer than 2 months and shorter than 6 months duration,

• VAS pain score of 5 or greater for the cervical/ upper back pain for 4 week period before injection,

• If female or child bearing potential, concurrent use of a reliable method of contraception.

Exclusion Criteria:

• Known allergy or sensitivity to Botulinum toxin type A.

• Any medical condition that may put the subject at increased risk with exposure to BOTOX®, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function

• Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function

• Pregnancy, breast feeding, or planned pregnancy

• Acute or operative pathology on cervical MRI

• History of treatment for gatro-esophageal reflux disease

• Abnormal finding on 3-oz water swallowing test on the initial screening visit