Therapeutic Use of Botulinum Toxin Type A in Treating Neck and Upper-Back Pain of Myofascial Origin: A Pilot Study
Presented as a poster to the American Academy of Physical Medicine and Rehabilitation, November 2006, Honolulu, HI.
Abstract
Lew HL, Lee EH, Castaneda A, Klima R, Date E. Therapeutic use of botulinum toxin type A in treating neck and upper-back pain of myofascial origin: a pilot study.
Objective
To determine the efficacy of botulinum toxin type A (BTX-A) in treating neck and upper-back pain of myofascial origin.
Design
A randomized, double-blind, placebo-controlled pilot study.
Setting
Outpatient physical medicine and rehabilitation clinic of a university-affiliated tertiary hospital.
Participants
A total of 29 subjects enrolled from among 45 screened patients. No subject withdrawal due to serious adverse events occurred.
Intervention
Subjects were evaluated at baseline, received a 1-time injection of either BTX-A (treatment group) or saline (control group), and were followed up at 2 weeks and at months 1, 2, 3, 4, and 6.
Main Outcome Measures
Visual analog scale (VAS) for pain, the Neck Disability Index (NDI), and the Medical Outcome Study 36-Item Short-Form Health Survey (SF-36).
Results
Improvements in the VAS and NDI scores were seen in the treatment group but were not significant when compared with the controls. Statistically significant improvements for the treatment group were seen in the SF-36 bodily pain (at months 2 and 4) and mental health (at month 1) scales but not in the other scales, nor in the summary measures. No serious adverse events were reported.
Conclusions
Trends toward improvements in VAS and NDI scores of the BTX-A group are encouraging, but they were possibly due to a placebo effect and were not statistically significant. The BTX-A subjects, at certain time points, showed statistically significant improvements in the bodily pain and mental health scales of the SF-36 compared with controls. Our study had limited power and population base, but the results could be used to properly power follow-up studies to further investigate this topic.
Physical Medicine and Rehabilitation Service, VA Palo Alto Health Care System, Palo Alto, CA; and Stanford University School of Medicine, Stanford, CA.
Reprint requests to Henry L. Lew, MD, PhD, VA Palo Alto Health Care System, PM&R Service (117), 3801 Miranda Ave, Palo Alto CA, 94304
Supported in part by Allergan Inc.
No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit upon the author(s) or upon any organization with which the author(s) is/are associated.