Safety and Efficacy Study of Botox in the Treatment of Forward Head Posture With Associated Episodic Headache Disorder
Recruitment status was: Recruiting
Forward Head Posture With Associated Episodic Headache Disorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|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|
- 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). [ Designated as safety issue: Yes ]
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).
- Determining the efficacy and safety of BOTOX injections [ Designated as safety issue: Yes ]
- 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.
|Study Start Date:||September 2009|
|Placebo Comparator: Saline||Drug: Saline|
|Active Comparator: Botox||Drug: Botox|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350375
|United States, California|
|The Research Center of Southern California|
|Oceanside, California, United States, 92056|