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

NCT ID: NCT01050972

Last Updated: 2010-07-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 15000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-11-30

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.

Conditions

Migraine; Tension Type Headache; Cervical Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive and physical program

Experimental: Cognitive and physical program. Non randomized residents in the territory of Piedmont (Piemonte) Italy.

Group Type: EXPERIMENTAL

Behavioral: Cognitive, Relaxation, Exercise Therapy

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione CRT, Torino

UNKNOWN

Sponsor Role: collaborator

Turin, Italy

OTHER

Sponsor Role: collaborator

Regione Piemonte

OTHER

Sponsor Role: collaborator

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Unit of Headache and Facial Pain, Dept. of Clinical Pathophysiology

Principal Investigators

Franco Mongini, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Headache and Facial Pain Unit Dept. Clinical Pathophysiology University of Turin

Locations

Headache and Facial Pain Unit University of Turin

Turin, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Franco Mongini, Professor

Role: CONTACT

franco.mongini@unito.it

00390116334041

Facility Contacts

Franco Mongini, Professor

Role: primary

franco.mongini@unito.it

00390116334041

Other Identifiers

3

Identifier Type: -

Identifier Source: org_study_id