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A RCT on the Efficacy of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Working Community
This study is currently recruiting participants.
Verified by University of Turin, Italy, October 2007
Sponsors and Collaborators: University of Turin, Italy
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

Genetics Home Reference related topics: familial hemiplegic migraine
MedlinePlus related topics: Exercise and Physical Fitness Headache Migraine Neck Injuries and Disorders
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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.

Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 2905
Study Start Date: October 2007
Estimated Study Completion Date: October 2008
Arms Assigned Interventions
A: Active Comparator 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

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).

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00551980

Contacts
Contact: Franco Mongini, Professor 0039.011.6334041 franco.mongini@unito.it

Locations
Italy
Headache and Facial Pain Unit University of Turin Recruiting
Torino, Italy, I-10126
Contact: Franco Mongini, Professor     00390116334041     franco.mongini@unito.it    
Principal Investigator: Chantal Milani, DDS            
Headache and Facial Pain Unit University of Turin Recruiting
Torino, Italy, I-10126
Sponsors and Collaborators
University of Turin, Italy
Compagnia di San Paolo
Comune di Torino
CPO Piemonte
Regione Piemonte
Investigators
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

Study ID Numbers: 1130SD2006.1911
Study First Received: October 31, 2007
Last Updated: October 31, 2007
ClinicalTrials.gov Identifier: NCT00551980  
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

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

Study placed in the following topic categories:
Signs and Symptoms
Migraine Disorders
Shoulder Pain
Tension-Type Headache
Neck Pain
Headache
Central Nervous System Diseases
Neurologic Manifestations
Headache Disorders, Primary
Pain
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009