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The Efficacy of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Working Community

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ClinicalTrials.gov Identifier: NCT00551980
Recruitment Status : Completed
First Posted : November 1, 2007
Last Update Posted : November 13, 2009
Sponsor:
Collaborators:
Compagnia di San Paolo
Turin, Italy
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Regione Piemonte
Information provided by:
University of Turin, Italy

Brief Summary:
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 or disease Intervention/treatment Phase
Migraine Tension Type Headache Cervical Pain Behavioral: Cognitive, Relaxation, Exercise Therapy Phase 3

Detailed Description:

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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2895 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
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

No Intervention: Control group
Randomized group of workers of the same institution ( City of Turin, Italy).



Primary Outcome Measures :
  1. 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 [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 12 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All the subjects employed at the Municipality of Turin at September, 2007 will be recruited.

Exclusion Criteria:

  • Because of the pragmatic design, no exclusion criteria are required for this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551980


Locations
Italy
Headache and Facial Pain Unit University of Turin
Torino, Italy, I-10126
Sponsors and Collaborators
University of Turin, Italy
Compagnia di San Paolo
Turin, Italy
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Regione Piemonte
Investigators
Study Chair: Franco Mongini, Professor University of Turin, Italy
Principal Investigator: 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: November 1, 2007    Key Record Dates
Last Update Posted: November 13, 2009
Last Verified: November 2009

Keywords provided by University of Turin, Italy:
Headache
Cervical Pain
Cognitive treatment
Relaxation
Exercise

Additional relevant MeSH terms:
Headache
Tension-Type Headache
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases