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Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Large Population

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Turin, Italy.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Fondazione CRT, Torino
Comune di Torino
Regione Piemonte
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT01050972
First received: January 15, 2010
Last updated: July 8, 2010
Last verified: July 2010
History of Changes
  Purpose

This study is an interventional trial to evaluate the effectiveness of a cognitive and physical program (Intervention), in reducing the frequency of head and neck pain in the population of an extensive territory of Italy.


Condition Intervention Phase
Migraine
Tension Type Headache
Cervical Pain
 Behavioral: Behavioral: Cognitive, Relaxation, Exercise Therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Population of an Extensive Territory

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • Reduction in number of days per month with headache and shoulders pain after 12 months. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in number of days per month of drug intake after 12 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 15000
Study Start Date: June 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All residents of the Region Piemonte (Italy) may apply for recruitment

Exclusion Criteria:

  • Because of the pragmatic design, no exclusion criteria are required for this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050972

Contacts
Contact: Franco Mongini, Professor 00390116334041 franco.mongini@unito.it

Locations
Italy
Headache and Facial Pain Unit University of Turin Recruiting
Turin, Italy, I-10126
Contact: Franco Mongini, Professor     00390116334041     franco.mongini@unito.it    
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.            
Sponsors and Collaborators
University of Turin, Italy
Fondazione CRT, Torino
Comune di Torino
Regione Piemonte
Investigators
Principal Investigator: Franco Mongini, MD, Prof. Headache and Facial Pain Unit Dept. Clinical Pathophysiology University of Turin
  More Information

No publications provided

Responsible Party: Franco Mongini/ Professor and chairman, Unit of Headache and Facial Pain, Dept. of Clinical Pathophysiology
ClinicalTrials.gov Identifier: NCT01050972     History of Changes
Other Study ID Numbers: 3
Study First Received: January 15, 2010
Last Updated: July 8, 2010
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by University of Turin, Italy:
Headache
Cervical Pain
Cognitive treatment
Relaxation
Exercise

Additional relevant MeSH terms:
Tension-Type Headache
Neck Pain
Headache
Migraine Disorders
Pain
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013