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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00457496 |
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Date of registration:
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05/04/2007 |
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Primary sponsor: |
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Public title:
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Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in Working Communities
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Scientific title:
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Effectiveness of a Cognitive and Physical Program in Reducing Headache, Neck and Shoulder Pain: a Workplace Controlled Trial |
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Date of first enrolment:
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March 2005 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00457496 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Contacts
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Name:
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Alessandro Ugolini, DDS |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Turin |
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Name:
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Eugenia Rota, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Turin |
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Name:
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Franco Mongini, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Turin |
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Name:
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Luca Ferrero, DDS |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Turin |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Headache
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Headache Disorders
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Neck Pain
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Shoulder Pain
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Intervention(s)
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Behavioral: Cognitive, behavioral, exercise
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Primary Outcome(s)
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Frequency of headache and neck and shoulder pain after 6 months (monthly frequency, responder rate)
[Time Frame: 6 months]
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Secondary Outcome(s)
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Analgesic drug consumption after 6 and 12 months
[Time Frame: 12 months]
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Frequency of pain in head/neck area after 12 months in both groups
[Time Frame: 12 months]
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Headache index after 6 and 12 months
[Time Frame: 12 months]
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Muscle tenderness at palpation after 6 and 12 months
[Time Frame: 12 months]
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Neck and shoulder pain index after 6 and 12 months
[Time Frame: 12 months]
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Psychiatric comorbidity and psychosomatic symptoms prevalence
[Time Frame: 12 months]
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Secondary ID(s)
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5147SD2003.0271
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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