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Sponsors and Collaborators: |
University of Turin, Italy Compagnia di San Paolo Comune di Torino CPO Piemonte Regione Piemonte |
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Information provided by: | University of Turin, Italy |
ClinicalTrials.gov Identifier: | NCT00551980 |
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
Condition | Intervention | Phase |
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Migraine Tension Type Headache Cervical Pain |
Behavioral: Cognitive, Relaxation, Exercise Therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effectiveness of a Workplace Cognitive and Physical Program in Reducing Headache,Neck and Shoulder Pain in an Extensive Working Community. A Randomized Controlled Trial. |
Estimated Enrollment: | 2905 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2008 |
Arms | Assigned Interventions |
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A: Active Comparator |
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
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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).
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Franco Mongini, Professor | 0039.011.6334041 | franco.mongini@unito.it |
Italy | |
Headache and Facial Pain Unit University of Turin | Recruiting |
Torino, Italy, I-10126 | |
Contact: Franco Mongini, Professor 00390116334041 franco.mongini@unito.it | |
Principal Investigator: Chantal Milani, DDS | |
Headache and Facial Pain Unit University of Turin | Recruiting |
Torino, Italy, I-10126 |
Study Chair: | Franco Mongini, Professor | University of Turin |
Principal Investigator: | Chantal Milani, DDS | University of Turin |
Principal Investigator: | Luca Ferrero, DDS | University of Turin |
Principal Investigator: | Alessandro Ugolini, DDS | University of Turin |
Principal Investigator: | Monica Sigaudo, DDS | University of Turin |
Principal Investigator: | Elisa Chiorino, Dr | University of Turin |
Study ID Numbers: | 1130SD2006.1911 |
Study First Received: | October 31, 2007 |
Last Updated: | October 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00551980 |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Headache Cervical Pain Cognitive treatment Relaxation Exercise |
Signs and Symptoms Migraine Disorders Shoulder Pain Tension-Type Headache Neck Pain Headache |
Central Nervous System Diseases Neurologic Manifestations Headache Disorders, Primary Pain Brain Diseases Headache Disorders |
Nervous System Diseases |