Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 12:07 AM
NCT ID:
NCT00282958
Eligibility 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
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00282958
Study Brief:
Protocol Section:
NCT00282958