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| Sponsor: | University of Turin, Italy |
|---|---|
| Collaborators: |
Compagnia di San Paolo Comune di Torino CPO Piemonte Regione Piemonte |
| Information provided by: | University of Turin, Italy |
| ClinicalTrials.gov Identifier: | NCT00551980 |
Purpose
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 |
|---|---|---|
|
Migraine Tension Type Headache Cervical Pain |
Behavioral: Cognitive, Relaxation, Exercise Therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Enrollment: | 2895 |
| Study Start Date: | October 2007 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cognitive and physical program
Randomized group of workers of the same institution ( City of Turin, Italy).
|
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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No Intervention: Control group
Randomized group of workers of the same institution ( City of Turin, Italy).
|
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).
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Italy | |
| Headache and Facial Pain Unit University of Turin | |
| 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 |
More Information
| Responsible Party: | Franco Mongini/ Professor and chairman, Unit of Headache and Facial Pain, Dept. of Clinical Pathophysiology |
| ClinicalTrials.gov Identifier: | NCT00551980 History of Changes |
| Other Study ID Numbers: | 1130SD2006.1911 |
| Study First Received: | October 31, 2007 |
| Last Updated: | November 12, 2009 |
| Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
|
Headache Cervical Pain Cognitive treatment Relaxation Exercise |
|
Neck Pain Headache Tension-Type Headache Migraine Disorders Pain Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases |