Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Large Population
Primary Purpose
Migraine, Tension Type Headache, Cervical Pain
Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Behavioral: Cognitive, Relaxation, Exercise Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring Headache, Cervical Pain, Cognitive treatment, Relaxation, Exercise
Eligibility 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
Sites / Locations
- Headache and Facial Pain Unit University of TurinRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive and physical program
Arm Description
Experimental: Cognitive and physical program. Non randomized residents in the territory of Piedmont (Piemonte) Italy.
Outcomes
Primary Outcome Measures
Reduction in number of days per month with headache and shoulders pain after 12 months.
Secondary Outcome Measures
Reduction in number of days per month of drug intake after 12 months
Full Information
NCT ID
NCT01050972
First Posted
January 15, 2010
Last Updated
July 8, 2010
Sponsor
University of Turin, Italy
Collaborators
Fondazione CRT, Torino, Turin, Italy, Regione Piemonte
1. Study Identification
Unique Protocol Identification Number
NCT01050972
Brief Title
Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Large Population
Official Title
Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Population of an Extensive Territory
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Turin, Italy
Collaborators
Fondazione CRT, Torino, Turin, Italy, Regione Piemonte
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Tension Type Headache, Cervical Pain
Keywords
Headache, Cervical Pain, Cognitive treatment, Relaxation, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive and physical program
Arm Type
Experimental
Arm Description
Experimental: Cognitive and physical program. Non randomized residents in the territory of Piedmont (Piemonte) Italy.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral: Cognitive, Relaxation, Exercise Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Reduction in number of days per month with headache and shoulders pain after 12 months.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Reduction in number of days per month of drug intake after 12 months
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Franco Mongini, Professor
Phone
00390116334041
Email
franco.mongini@unito.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco Mongini, MD, Prof.
Organizational Affiliation
Headache and Facial Pain Unit Dept. Clinical Pathophysiology University of Turin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Headache and Facial Pain Unit University of Turin
City
Turin
ZIP/Postal Code
I-10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franco Mongini, Professor
Phone
00390116334041
Email
franco.mongini@unito.it
First Name & Middle Initial & Last Name & Degree
Franco Mongini, MD
First Name & Middle Initial & Last Name & Degree
Chantal Milani, DDS
First Name & Middle Initial & Last Name & Degree
Emanuela Banzatti, DDS
First Name & Middle Initial & Last Name & Degree
Luca Ferrero, DDS
First Name & Middle Initial & Last Name & Degree
Alessandro Ugolini, DDS
First Name & Middle Initial & Last Name & Degree
Alessandro Piedimonte, Dr.
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Large Population
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