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

Phase 3

• Conditions: Migraine; Tension Type Headache; Cervical Pain

• Registration Number: NCT01050972
• Lead Sponsor: University of Turin, Italy

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-18
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-08
• Last Update Posted: 2010-07-09
• Primary Completion: 2011-06
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15000

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reduction in number of days per month with headache and shoulders pain after 12 months.	24 months

Secondary Outcome Measures

Name	Time	Method
Reduction in number of days per month of drug intake after 12 months	24 months

Trial Locations

Locations (1)

Headache and Facial Pain Unit University of Turin; 🇮🇹 Turin, Italy