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

Migraine Clinical Trial

Official title:

Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Population of an Extensive Territory

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01050972
• Other study ID #: 3
• Status: Recruiting
• Phase: Phase 3
• First received: January 15, 2010
• Last updated: July 8, 2010
• Start date: June 2009
• Est. completion date: November 2011

Study information

• Verified date: July 2010
• Source: University of Turin, Italy
• Contact: Franco Mongini, Professor
• Phone: 00390116334041
• Email: franco.mongini[@]unito.it
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: November 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Pain
• Migraine
• Neck Pain
• Tension Type Headache
• Tension-Type Headache

Intervention

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

Locations

Country	Name	City	State
Italy	Headache and Facial Pain Unit University of Turin	Turin

Sponsors (4)

Lead Sponsor	Collaborator
University of Turin, Italy	Fondazione CRT, Torino, Regione Piemonte, Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in number of days per month with headache and shoulders pain after 12 months.		24 months	No
Secondary	Reduction in number of days per month of drug intake after 12 months		24 months	No