Forward Head Posture With Associated Episodic Headache Disorder Clinical Trial
Official title:
A Randomized Double-Blind Placebo Controlled Multi-Center Study to Evaluate the Safety and Efficacy of Botulinum Neurotoxin Type A in the Treatment of Forward Head Posture With Associated Episodic Headache Disorder
This study will investigate the therapeutic utility of BOTOX in reducing the degree of Forward Head Posture (FHP) with associated headache and myofascial pain, decreasing the frequency of headache, and improving the overall quality of life.
This is a multi-center, prospective, double-blind, placebo-controlled parallel study
investigating the use of BOTOX in the treatment of patients with FHP and associated headache
using a novel fixed site injection paradigm.
Fifteen subjects will be randomized to receive BOTOX® and fifteen will receive placebo
injections. Study subjects will receive one cycle of injections, up to a maximal total dosage
of 250U. The study duration is approximately 4 months and is composed of a Screening Visit
(Visit 1, Month -1), a Baseline Visit (Visit 2, Day 0), and three Follow-Up Visits 1 month
apart (Months 1, 2 and 3).
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