Original article
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.
https://doi.org/10.1016/j.apmr.2007.08.133Get rights and content

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.

Section snippets

Participants

Twenty-nine adult subjects with diagnoses of cervical or upper-back pain of myofascial origin participated in the study. Through flyers and advertisements, subjects were recruited from the general population and the patient population of the physical medicine and rehabilitation clinic in a university-affiliated tertiary hospital. The study was approved by the institutional review board of the hospital’s affiliated university. Subjects were included if they (1) had been diagnosed as having neck

Demographics

Thirty subjects consented and were randomized to the study. One subject was excluded in the analysis because his age exceeded 70 years, which was a protocol deviation. There were 20 men and 9 women among the 29 subjects included in the analysis. An analysis of the group characteristics regarding age, sex, and race yielded no significant group differences between the treatment and control subjects (table 1). A comparison of the BTX-A and control groups showed no baseline differences in the

Discussion

BTX-A inhibits acetylcholine release from motor nerve terminals at the neuromuscular junction, resulting in reversible chemical denervation and temporary (3–4mo) relief of muscle spasm.2, 3, 4 But it has also been proposed that the pain relief resulting from BTX-A injection is due to mechanisms other than chemodenervation. Precisely what these mechanisms are remain unclear, but it has been postulated that BTX-A acts centrally on spinal interneurons, through antagonism with substance P, and

Conclusions

This study is among few randomized controlled investigations on the use of trigger point injections of BTX-A for the treatment of myofascial neck and upper back pain. Within the limitations of this pilot study, when compared with saline, BTX-A injections did not result in statistically significant changes in NDI and VAS measures. However, compared with controls, BTX-A injections produced significantly better outcomes in bodily pain (at 2 and 4 months postinjection) and mental health scales (at

Acknowledgment

Data analysis conducted by ethica Clinical Research Inc.

References (23)

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    (2002)
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    Supported in part by Allergan Inc.

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