Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Large Population
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|ClinicalTrials.gov Identifier: NCT01050972|
Recruitment Status : Unknown
Verified July 2010 by University of Turin, Italy.
Recruitment status was: Recruiting
First Posted : January 18, 2010
Last Update Posted : July 9, 2010
|Condition or disease||Intervention/treatment||Phase|
|Migraine Tension Type Headache Cervical Pain||Behavioral: Behavioral: Cognitive, Relaxation, Exercise Therapy||Phase 3|
In a previous non-randomized-controlled study in which the cognitive and physical programme was applied to a consistent number of office workers, a significant reduction of frequency of pain in the head and neck areas and of analgesic drug consumption was obtained. The results were stable at a 12 month follow up. More recently a controlled, cluster randomised, interventional trial was conducted on 1930 local government employees of the Municipality of Turin. The data obtained confirm those of the previous studies.
The present study was designed to confirm the data in a much more extensive population , that is, residents of the Italian Region Piemonte (Piedmont) who will apply to participate.
Primary objective is to confirm the effectiveness of the cognitive and physical programme (Intervention), in reducing the frequency of pain involving the head and neck area in a large population of a territory.
Secondary objective is to confirm the effectiveness of the Intervention, in reducing analgesic drugs consumption after the Intervention in the same population.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Population of an Extensive Territory|
|Study Start Date :||June 2009|
|Estimated Primary Completion Date :||June 2011|
|Estimated Study Completion Date :||November 2011|
Experimental: Cognitive and physical program
Experimental: Cognitive and physical program. Non randomized residents in the territory of Piedmont (Piemonte) Italy.
Behavioral: Behavioral: Cognitive, Relaxation, Exercise Therapy
Behavioral: Cognitive, Relaxation, Exercise Therapy The intervention consists of brief shoulder and neck exercises to be performed several times a day, a relaxation exercise and instructions of how to reduce hyperfunction of the craniofacial and cervical muscles during the day
- Reduction in number of days per month with headache and shoulders pain after 12 months. [ Time Frame: 24 months ]
- Reduction in number of days per month of drug intake after 12 months [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050972
|Contact: Franco Mongini, Professorfirstname.lastname@example.org|
|Headache and Facial Pain Unit University of Turin||Recruiting|
|Turin, Italy, I-10126|
|Contact: Franco Mongini, Professor 00390116334041 email@example.com|
|Principal Investigator: Franco Mongini, MD|
|Sub-Investigator: Chantal Milani, DDS|
|Sub-Investigator: Emanuela Banzatti, DDS|
|Sub-Investigator: Luca Ferrero, DDS|
|Sub-Investigator: Alessandro Ugolini, DDS|
|Sub-Investigator: Alessandro Piedimonte, Dr.|
|Principal Investigator:||Franco Mongini, MD, Prof.||Headache and Facial Pain Unit Dept. Clinical Pathophysiology University of Turin|