drugset / Trial / NCT00178945
Botulinum Toxin Type A (Botox) for the Treatment of Cervical Dystonia and Upper Thoracic Muscular Pain
RandomizedCrossoverDouble-blindTreatment
Summary
The purpose of this study is to investigate the use of injections of Botox (botulinum toxin type A) for the treatment of chronic neck pain. Botox is an approved treatment for patients with cervical dystonia. Cervical dystonia is a chronic condition characterized by involuntary movements of the neck that are often painful. In this study, the response from Botox in patients with neck pain not associated with cervical dystonia will be compared to the pain response in patients with cervical dystonia.
Timeline
- Start
- 2004-03
- Primary completion
- —
- Completion
- 2006-03
Publications
- Background Comella CL, Buchman AS, Tanner CM, Brown-Toms NC, Goetz CG. Botulinum toxin injection for spasmodic torticollis: increased magnitude of benefit with electromyographic assistance. Neurology. 1992 Apr;42(4):878-82. doi: 10.1212/wnl.42.4.878.
- Background Freund BJ, Schwartz M. Treatment of whiplash associated neck pain [corrected] with botulinum toxin-A: a pilot study. J Rheumatol. 2000 Feb;27(2):481-4.
- Background Gobel H, Heinze A, Heinze-Kuhn K, Austermann K. Botulinum toxin A in the treatment of headache syndromes and pericranial pain syndromes. Pain. 2001 Apr;91(3):195-199. doi: 10.1016/S0304-3959(01)00292-5. No abstract available.
- Background Porta M. A comparative trial of botulinum toxin type A and methylprednisolone for the treatment of myofascial pain syndrome and pain from chronic muscle spasm. Pain. 2000 Mar;85(1-2):101-5. doi: 10.1016/s0304-3959(99)00264-x.
- Background Wheeler AH, Goolkasian P, Gretz SS. A randomized, double-blind, prospective pilot study of botulinum toxin injection for refractory, unilateral, cervicothoracic, paraspinal, myofascial pain syndrome. Spine (Phila Pa 1976). 1998 Aug 1;23(15):1662-6; discussion 1667. doi: 10.1097/00007632-199808010-00009.
- Background Wheeler AH, Goolkasian P, Gretz SS. Botulinum toxin A for the treatment of chronic neck pain. Pain. 2001 Dec;94(3):255-260. doi: 10.1016/S0304-3959(01)00358-X.
- Background Botox(R) (Botulinum Toxin Type A) Purified Neurotoxin Complex. Package Insert.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | — | — |