NCT01050972

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15,000 (estimated)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 15 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-06-01
• Completion: 2011-11-01
• First posted: 2010-01-18
• Last updated: 2010-07-09

Locations

1 site across 1 country: Italy