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| Name | Class |
|---|---|
| Compagnia di San Paolo | OTHER |
| Turin, Italy | OTHER |
| Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte | OTHER |
| Regione Piemonte |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive and physical program | Experimental | Randomized group of workers of the same institution ( City of Turin, Italy). |
|
| Control group | No Intervention | Randomized group of workers of the same institution ( City of Turin, Italy). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive, Relaxation, Exercise Therapy | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in number of days per month with headache and shoulders pain after 6 months.Proportion of subjects with more than 4 days with headache and shoulder pain at the baseline that will have reduction in pain frequency of more than 50%, after 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Headache index (Intensity x Frequency) after 6 and 12 months. Frequency of analgesic drug consumption after 6 and 12 months Frequency of headache and shoulder pain after 12 months | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franco Mongini, Professor | University of Turin, Italy | Study Chair |
| Chantal Milani, DDS | University of Turin, Italy | Principal Investigator |
| Luca Ferrero, DDS | University of Turin, Italy | Principal Investigator |
| Alessandro Ugolini, DDS | University of Turin, Italy | Principal Investigator |
| Monica Sigaudo, DDS | University of Turin, Italy | Principal Investigator |
| Elisa Chiorino, Dr | University of Turin, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Headache and Facial Pain Unit University of Turin | Torino | I-10126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22253751 | Derived | 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. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D018781 | Tension-Type Headache |
| D019547 | Neck Pain |
| D006261 | Headache |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| OTHER |
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| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |