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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

About this trial

This is an interventional treatment trial for Migraine focused on measuring Headache, Cervical Pain, Cognitive treatment, Relaxation, Exercise

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

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

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

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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