Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in Working Communities
Primary Purpose
Headache Disorders, Headache, Neck Pain
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Cognitive, behavioral, exercise
Sponsored by
About this trial
This is an interventional treatment trial for Headache Disorders focused on measuring Behavior Therapy, Relaxation Techniques, Cognitive Therapy, Exercise Movement Techniques
Eligibility Criteria
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.
Exclusion Criteria:
- Because of the pragmatic design, no exclusion criteria are required for this study
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Frequency of headache and neck and shoulder pain after 6 months (monthly frequency, responder rate)
Secondary Outcome Measures
Analgesic drug consumption after 6 and 12 months
Headache index after 6 and 12 months
Neck and shoulder pain index after 6 and 12 months
Muscle tenderness at palpation after 6 and 12 months
Psychiatric comorbidity and psychosomatic symptoms prevalence
Frequency of pain in head/neck area after 12 months in both groups
Full Information
NCT ID
NCT00457496
First Posted
April 5, 2007
Last Updated
July 11, 2008
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
NCT00457496
Brief Title
Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in Working Communities
Official Title
Effectiveness of a Cognitive and Physical Program in Reducing Headache, Neck and Shoulder Pain: a Workplace Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (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
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache Disorders, Headache, Neck Pain, Shoulder Pain
Keywords
Behavior Therapy, Relaxation Techniques, Cognitive Therapy, Exercise Movement Techniques
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cognitive, behavioral, exercise
Intervention Description
Relaxation exercises once a day, visual feedback, exercises for neck and shoulder
Primary Outcome Measure Information:
Title
Frequency of headache and neck and shoulder pain after 6 months (monthly frequency, responder rate)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Analgesic drug consumption after 6 and 12 months
Time Frame
12 months
Title
Headache index after 6 and 12 months
Time Frame
12 months
Title
Neck and shoulder pain index after 6 and 12 months
Time Frame
12 months
Title
Muscle tenderness at palpation after 6 and 12 months
Time Frame
12 months
Title
Psychiatric comorbidity and psychosomatic symptoms prevalence
Time Frame
12 months
Title
Frequency of pain in head/neck area after 12 months in both groups
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
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
Eugenia Rota, MD
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
Luca Ferrero, DDS
Organizational Affiliation
University of Turin, Italy
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in Working Communities
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