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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Migraine, Tension Type Headache, Cervical Pain

Intervention / Treatment
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* Behavioral: Behavioral: Cognitive, Relaxation, Exercise Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive and physical program<br>Experimental: Cognitive and physical program. Non randomized residents in the territory of Piedmont (Piemonte) Italy. | Behavioral: Behavioral: Cognitive, Relaxation, Exercise Therapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in number of days per month with headache and shoulders pain after 12 months. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in number of days per month of drug intake after 12 months |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Headache, Cervical Pain, Cognitive treatment, Relaxation, Exercise