Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in Working Communities

NCT ID: NCT00457496

Last Updated: 2008-07-14

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

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-04-30

Brief Summary

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The primary purpose of this study is to evaluate the effectiveness of a workplace cognitive and physical program (Intervention), in reducing the frequency of head and neck pain

Detailed Description

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Many studies have been 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.

The primary objective of this study is to evaluate the effectiveness of a workplace cognitive and physical programme (Intervention) in reducing the frequency of pain involving the head and neck area. 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.

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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Headache Disorders Headache Neck Pain Shoulder Pain

Keywords

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Behavior Therapy Relaxation Techniques Cognitive Therapy Exercise Movement Techniques

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Cognitive, behavioral, exercise

Intervention Type BEHAVIORAL

Relaxation exercises once a day, visual feedback, exercises for neck and shoulder

Interventions

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Cognitive, behavioral, exercise

Relaxation exercises once a day, visual feedback, exercises for neck and shoulder

Intervention Type BEHAVIORAL

Eligibility 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.
Minimum Eligible Age

18 Years

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

Eugenia Rota, MD

Role: PRINCIPAL_INVESTIGATOR

University of Turin, Italy

Alessandro Ugolini, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Turin, Italy

Luca Ferrero, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Turin, Italy

Other Identifiers

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5147SD2003.0271

Identifier Type: -

Identifier Source: org_study_id