Clinical Trial: Safety and Efficacy Study of Botox in the Treatment of Forward Head Posture With Associated Episodic Headache Disorder

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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).


Sponsor: The Research Center of Southern California

Current Primary Outcome: Determining the efficacy and safety of BOTOX injections • The change in number of headache free days; • % days with headache; • Average headache severity; • Number of headache episodes (number of headaches).

The primary objective of this study is to determine the efficacy and safety of BOTOX injections in the treatment of forward head posture with associated Episodic Headache Disorder through:

  • The change in number of headache free days;
  • % days with headache;
  • Average headache severity;
  • Number of headache episodes (number of headaches).


Original Primary Outcome: Same as current

Current Secondary Outcome: Determining the efficacy and safety of BOTOX injections

  • To determine the efficacy and safety of BOTOX injections on the change in forward head posture as measured by the improvement in the degree of FHP (measured in cm and finger breadths) at the primary analysis point of 8 weeks post-injection.
  • To determine the efficacy and safety of BOTOX injections on the change in myofascial pain measured on visual analog scale scores.


Original Secondary Outcome: Same as current

Information By: The Research Center of Southern California

Dates:
Date Received: May 6, 2011
Date Started: September 2009
Date Completion:
Last Updated: May 6, 2011
Last Verified: April 2011