The Efficacy of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Working Community

Study Overview
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Brief Summary
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This study is a controlled, cluster randomised, interventional trial to evaluate the effectiveness of a workplace cognitive and physical program (Intervention), in reducing the frequency of head and neck pain in an extensive working population.

Detailed Description
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Many studies were performed to assess the efficacy of non invasive physical interventions in the treatment of different types of headache and cervical pain. However the evidence on their effectiveness is still limited and the results of recent studies are conflicting. 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 present study was designed to confirm the data in a much more extensive working population and applying a randomised design. The primary objective is to confirm the effectiveness of a workplace cognitive and physical programme (Intervention), in reducing the frequency of pain involving the head and neck area in a large working community using a randomized design.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 parafunction and hyperfunction of the craniofacial and cervical muscles during the day. Secondary objectives: To confirm the effectiveness of the Intervention, in reducing the intensity of pain involving the head and neck area in a large working community using a randomized design. To confirm the reduction in analgesic drugs consumption after the Intervention in a large working community using a randomized design. To evaluate the persistence of the effectiveness of the Intervention after 12 months in a large working community using a randomized design. Comparison(s): Group of employees that will receive a cognitive/physical programme (Intervention), compared to a similar group of employees that will not receive the Intervention (Controls); (frequency of headache and neck and shoulder pain).

Official Title
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Effectiveness of a Workplace Cognitive and Physical Program in Reducing Headache,Neck and Shoulder Pain in an Extensive Working Community. A Randomized Controlled Trial

Conditions
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Migraine, Tension Type Headache, Cervical Pain

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All the subjects employed at the Municipality of Turin at September, 2007 will be recruited. Exclusion Criteria: Because of the pragmatic design, no exclusion criteria are required for this study.
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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive and physical program<br>Randomized group of workers of the same institution ( City of Turin, Italy). | Behavioral: Cognitive, Relaxation, Exercise Therapy<br>* 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>|
| No Intervention: Control group<br>Randomized group of workers of the same institution ( City of Turin, Italy). | |

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 6 months.Proportion of subjects with more than 4 days with headache and shoulder pain at the baseline that will have reduction in pain frequency of more than 50%, after 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache index (Intensity x Frequency) after 6 and 12 months. Frequency of analgesic drug consumption after 6 and 12 months Frequency of headache and shoulder pain after 12 months |  | 12 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