The Efficacy of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Working Community
Primary Purpose
Migraine, Tension Type Headache, Cervical Pain
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Cognitive, Relaxation, Exercise Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring Headache, Cervical Pain, Cognitive treatment, Relaxation, Exercise
Eligibility 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.
Sites / Locations
- Headache and Facial Pain Unit University of Turin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cognitive and physical program
Control group
Arm Description
Randomized group of workers of the same institution ( City of Turin, Italy).
Randomized group of workers of the same institution ( City of Turin, Italy).
Outcomes
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
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
Full Information
NCT ID
NCT00551980
First Posted
October 31, 2007
Last Updated
November 12, 2009
Sponsor
University of Turin, Italy
Collaborators
Compagnia di San Paolo, Turin, Italy, Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte, Regione Piemonte
1. Study Identification
Unique Protocol Identification Number
NCT00551980
Brief Title
The Efficacy of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Working Community
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 Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Turin, Italy
Collaborators
Compagnia di San Paolo, Turin, Italy, Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte, Regione Piemonte
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Tension Type Headache, Cervical Pain
Keywords
Headache, Cervical Pain, Cognitive treatment, Relaxation, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2895 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive and physical program
Arm Type
Experimental
Arm Description
Randomized group of workers of the same institution ( City of Turin, Italy).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Randomized group of workers of the same institution ( City of Turin, Italy).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive, Relaxation, Exercise Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco Mongini, Professor
Organizational Affiliation
University of Turin, Italy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chantal Milani, DDS
Organizational Affiliation
University of Turin, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luca Ferrero, DDS
Organizational Affiliation
University of Turin, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alessandro Ugolini, DDS
Organizational Affiliation
University of Turin, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Monica Sigaudo, DDS
Organizational Affiliation
University of Turin, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elisa Chiorino, Dr
Organizational Affiliation
University of Turin, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Headache and Facial Pain Unit University of Turin
City
Torino
ZIP/Postal Code
I-10126
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
22253751
Citation
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.
Results Reference
derived
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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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