Botulinum toxin a in the treatment of chronic tension-type headache with cervical myofascial trigger points: a randomized, double-blind, placebo-controlled pilot study.
OBJECTIVE
To evaluate the efficacy of botulinum toxin A (BT-A) as a prophylactic treatment for chronic tension-type headache (CTTH) with myofascial trigger points (MTPs) producing referred head pain.


BACKGROUND
Although BT-A has received mixed support for the treatment of TTH, deliberate injection directly into the cervical MTPs very often found in this population has not been formally evaluated.


METHODS
Patients with CTTH and specific MTPs producing referred head pain were assigned randomly to receive intramuscular injections of BT-A or isotonic saline (placebo) in a double-blind design. Daily headache diaries, pill counts, trigger point pressure algometry, range of motion assessment, and responses to standardized pain and psychological questionnaires were used as outcome measures; patients returned for follow-up assessment at 2 weeks, 1 month, 2 months, and 3 months post injection. After 3 months, all patients were offered participation in an open-label extension of the study. Effect sizes were calculated to index treatment effects among the intent-to-treat population; individual time series models were computed for average pain intensity.


RESULTS
The 23 participants reported experiencing headache on a near-daily basis (average of 27 days/month). Compared with placebo, patients in the BT-A group reported greater reductions in headache frequency during the first part of the study (P = .013), but these effects dissipated by week 12. Reductions in headache intensity over time did not differ significantly between groups (P = .80; maximum d = 0.13), although a larger proportion of BT-A patients showed evidence of statistically significant improvements in headache intensity in the time series analyses (62.5% for BT-A vs 30% for placebo). There were no differences between the groups on any of the secondary outcome measures.


CONCLUSIONS
The evidence for BT-A in headache is mixed, and even more so in CTTH. However, the putative technique of injecting BT-A directly into the ubiquitous MTPs in CTTH is partially supported in this pilot study. Definitive trials with larger samples are needed to test this hypothesis further.
Harden
R Norman
RN
Center for Pain Studies, Rehabilitation Institute of Chicago, 446 E. Ontario, Chicago, IL 60611, USA.
Cottrill
Jerod
J
Gagnon
Christine M
CM
Smitherman
Todd A
TA
Weinland
Stephan R
SR
Tann
Beverley
B
Joseph
Petra
P
Lee
Thomas S
TS
Houle
Timothy T
TT
D000328:Adult; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage*; D002908:Chronic Disease / Q000188:drug therapy; D004311:Double-Blind Method; D005205:Fascia / Q000187:drug effects / Q000503:physiopathology; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D009209:Myofascial Pain Syndromes / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D009334:Neck Muscles / Q000187:drug effects* / Q000294:innervation / Q000503:physiopathology; D009465:Neuromuscular Agents / Q000008:administration & dosage*; D009483:Neuropsychological Tests; D010147:Pain Measurement; D010865:Pilot Projects; D010919:Placebos; D011795:Surveys and Questionnaires; D018781:Tension-Type Headache / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome
D009465:Neuromuscular Agents; D010919:Placebos; D019274:Botulinum Toxins, Type A