Status:
COMPLETED
The Therapeutic Use of Botulinum Toxin Type A in Subacute Cervical/Upper Back Pain
Lead Sponsor:
Palo Alto Veterans Institute for Research
Collaborating Sponsors:
Allergan
Conditions:
Subacute Cervical Pain
Subacute Upper Back Pain
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
To determine the therapeutic efficacy of Botox not only for chronic cervical/upper back pain but also for subacute pain.
Detailed Description
Subjects diagnosed with subacute (2-6 months post-onset) bilateral cervical/ upper back pain will be recruited in this double-blind control study. A total of 30 subjects with subacute cervical/upper ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00282958
Start Date
February 1 2003
End Date
July 1 2006
Last Update
March 5 2015
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