Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in Working Communities

Study Overview
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Brief Summary
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The primary purpose of this study is to evaluate the effectiveness of a workplace cognitive and physical program (Intervention), in reducing the frequency of head and neck pain

Detailed Description
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Many studies have been 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. The primary objective of this study is to evaluate the effectiveness of a workplace cognitive and physical programme (Intervention) in reducing the frequency of pain involving the head and neck area. 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. 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 Cognitive and Physical Program in Reducing Headache, Neck and Shoulder Pain: a Workplace Controlled Trial

Conditions
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Headache Disorders, Headache, Neck Pain, Shoulder Pain

Intervention / Treatment
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* Behavioral: Cognitive, behavioral, exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects employed at the Municipality of Turin ( Registry-Tax office) from the 1th January 2005 that will give informed consent before starting the study. 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: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Behavioral: Cognitive, behavioral, exercise<br>* Relaxation exercises once a day, visual feedback, exercises for neck and shoulder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of headache and neck and shoulder pain after 6 months (monthly frequency, responder rate) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic drug consumption after 6 and 12 months |  | 12 months | 
| Headache index after 6 and 12 months |  | 12 months | 
| Neck and shoulder pain index after 6 and 12 months |  | 12 months | 
| Muscle tenderness at palpation after 6 and 12 months |  | 12 months | 
| Psychiatric comorbidity and psychosomatic symptoms prevalence |  | 12 months | 
| Frequency of pain in head/neck area after 12 months in both groups |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavior Therapy, Relaxation Techniques, Cognitive Therapy, Exercise Movement Techniques