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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2895 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Migraine Tension Type Headache Cervical Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cognitive and physical program

Randomized group of workers of the same institution ( City of Turin, Italy).

Group Type EXPERIMENTAL

Cognitive, Relaxation, Exercise Therapy

Intervention Type 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

Control group

Randomized group of workers of the same institution ( City of Turin, Italy).

Group Type NO_INTERVENTION

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All the subjects employed at the Municipality of Turin at September, 2007 will be recruited.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Compagnia di San Paolo

OTHER

Sponsor Role collaborator

Turin, Italy

OTHER

Sponsor Role collaborator

Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

OTHER

Sponsor Role collaborator

Regione Piemonte

OTHER

Sponsor Role collaborator

University of Turin, Italy

OTHER

Sponsor Role lead

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

Site Status

Countries

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Italy

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.

Reference Type DERIVED
PMID: 22253751 (View on PubMed)

Other Identifiers

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1130SD2006.1911

Identifier Type: -

Identifier Source: org_study_id

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