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Clinical Trials/NCT01050972
NCT01050972
Unknown
Phase 3

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

University of Turin, Italy1 site in 1 country15,000 target enrollmentJune 2009

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Migraine
Sponsor
University of Turin, Italy
Enrollment
15000
Locations
1
Primary Endpoint
Reduction in number of days per month with headache and shoulders pain after 12 months.
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
November 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University of Turin, Italy

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

Outcomes

Primary Outcomes

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

Time Frame: 24 months

Secondary Outcomes

  • Reduction in number of days per month of drug intake after 12 months(24 months)

Study Sites (1)

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