- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01050972
Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Large Population
Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Population of an Extensive Territory
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 results were stable at a 12 month follow up. More recently a controlled, cluster randomised, interventional trial was conducted on 1930 local government employees of the Municipality of Turin. The data obtained confirm those of the previous studies.
The present study was designed to confirm the data in a much more extensive population , that is, residents of the Italian Region Piemonte (Piedmont) who will apply to participate.
Primary objective is to confirm the effectiveness of the cognitive and physical programme (Intervention), in reducing the frequency of pain involving the head and neck area in a large population of a territory.
Secondary objective is to confirm the effectiveness of the Intervention, in reducing analgesic drugs consumption after the Intervention in the same population.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Franco Mongini, Professor
- Phone Number: 00390116334041
- Email: franco.mongini@unito.it
Study Locations
-
-
-
Turin, Italy, I-10126
- Recruiting
- Headache and Facial Pain Unit University of Turin
-
Contact:
- Franco Mongini, Professor
- Phone Number: 00390116334041
- Email: franco.mongini@unito.it
-
Principal Investigator:
- Franco Mongini, MD
-
Sub-Investigator:
- Chantal Milani, DDS
-
Sub-Investigator:
- Emanuela Banzatti, DDS
-
Sub-Investigator:
- Luca Ferrero, DDS
-
Sub-Investigator:
- Alessandro Ugolini, DDS
-
Sub-Investigator:
- Alessandro Piedimonte, Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All residents of the Region Piemonte (Italy) may apply for recruitment
Exclusion Criteria:
- Because of the pragmatic design, no exclusion criteria are required for this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cognitive and physical program
Experimental: Cognitive and physical program.
Non randomized residents in the territory of Piedmont (Piemonte) 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in number of days per month with headache and shoulders pain after 12 months.
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in number of days per month of drug intake after 12 months
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Franco Mongini, MD, Prof., Headache and Facial Pain Unit Dept. Clinical Pathophysiology University of Turin
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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