The Efficacy of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Working Community
NCT ID: NCT00551980
Last Updated: 2009-11-13
Study Results
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Basic Information
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COMPLETED
PHASE3
2895 participants
INTERVENTIONAL
2007-10-31
2009-11-30
Brief Summary
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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 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cognitive and physical program
Randomized group of workers of the same institution ( City of Turin, Italy).
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
Control group
Randomized group of workers of the same institution ( City of Turin, Italy).
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
ALL
Yes
Sponsors
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Compagnia di San Paolo
OTHER
Turin, Italy
OTHER
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
OTHER
Regione Piemonte
OTHER
University of Turin, Italy
OTHER
Responsible Party
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Unit of Headache and Facial Pain, Dept. of Clinical Pathophysiology
Principal Investigators
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Franco Mongini, Professor
Role: STUDY_CHAIR
University of Turin, Italy
Chantal Milani, DDS
Role: PRINCIPAL_INVESTIGATOR
University of Turin, Italy
Luca Ferrero, DDS
Role: PRINCIPAL_INVESTIGATOR
University of Turin, Italy
Alessandro Ugolini, DDS
Role: PRINCIPAL_INVESTIGATOR
University of Turin, Italy
Monica Sigaudo, DDS
Role: PRINCIPAL_INVESTIGATOR
University of Turin, Italy
Elisa Chiorino, Dr
Role: PRINCIPAL_INVESTIGATOR
University of Turin, Italy
Locations
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Headache and Facial Pain Unit University of Turin
Torino, , Italy
Countries
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References
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Mongini F, Evangelista A, Milani C, Ferrero L, Ciccone G, Ugolini A, Piedimonte A, Sigaudo M, Carlino E, Banzatti E, Galassi C. An educational and physical program to reduce headache, neck/shoulder pain in a working community: a cluster-randomized controlled trial. PLoS One. 2012;7(1):e29637. doi: 10.1371/journal.pone.0029637. Epub 2012 Jan 9.
Other Identifiers
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1130SD2006.1911
Identifier Type: -
Identifier Source: org_study_id
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