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Botulinum toxin a in the treatment of chronic tension-type headache with cervical myofascial trigger points: a randomized, double-blind, placebo-controlled pilot study.
Headache. 2009 May; 49(5):732-43.H

Abstract

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.

Authors+Show Affiliations

Center for Pain Studies, Rehabilitation Institute of Chicago, 446 E. Ontario, Chicago, IL 60611, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19178577

Citation

Harden, R Norman, et al. "Botulinum Toxin a in the Treatment of Chronic Tension-type Headache With Cervical Myofascial Trigger Points: a Randomized, Double-blind, Placebo-controlled Pilot Study." Headache, vol. 49, no. 5, 2009, pp. 732-43.
Harden RN, Cottrill J, Gagnon CM, et al. Botulinum toxin a in the treatment of chronic tension-type headache with cervical myofascial trigger points: a randomized, double-blind, placebo-controlled pilot study. Headache. 2009;49(5):732-43.
Harden, R. N., Cottrill, J., Gagnon, C. M., Smitherman, T. A., Weinland, S. R., Tann, B., Joseph, P., Lee, T. S., & Houle, T. T. (2009). Botulinum toxin a in the treatment of chronic tension-type headache with cervical myofascial trigger points: a randomized, double-blind, placebo-controlled pilot study. Headache, 49(5), 732-43. https://doi.org/10.1111/j.1526-4610.2008.01286.x
Harden RN, et al. Botulinum Toxin a in the Treatment of Chronic Tension-type Headache With Cervical Myofascial Trigger Points: a Randomized, Double-blind, Placebo-controlled Pilot Study. Headache. 2009;49(5):732-43. PubMed PMID: 19178577.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Botulinum toxin a in the treatment of chronic tension-type headache with cervical myofascial trigger points: a randomized, double-blind, placebo-controlled pilot study. AU - Harden,R Norman, AU - Cottrill,Jerod, AU - Gagnon,Christine M, AU - Smitherman,Todd A, AU - Weinland,Stephan R, AU - Tann,Beverley, AU - Joseph,Petra, AU - Lee,Thomas S, AU - Houle,Timothy T, Y1 - 2008/10/24/ PY - 2009/1/31/entrez PY - 2009/1/31/pubmed PY - 2009/8/26/medline SP - 732 EP - 43 JF - Headache JO - Headache VL - 49 IS - 5 N2 - 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. SN - 1526-4610 UR - https://www.unboundmedicine.com/medline/citation/19178577/Botulinum_toxin_a_in_the_treatment_of_chronic_tension_type_headache_with_cervical_myofascial_trigger_points:_a_randomized_double_blind_placebo_controlled_pilot_study_ L2 - https://doi.org/10.1111/j.1526-4610.2008.01286.x DB - PRIME DP - Unbound Medicine ER -