Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Large Population
Study Details
Study Description
Brief Summary
This study is an interventional trial to evaluate the effectiveness of a cognitive and physical program (Intervention), in reducing the frequency of head and neck pain in the population of an extensive territory of Italy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cognitive and physical program Experimental: Cognitive and physical program. Non randomized residents in the territory of Piedmont (Piemonte) Italy. |
Behavioral: Behavioral: Cognitive, Relaxation, Exercise Therapy
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
|
Outcome Measures
Primary Outcome Measures
- Reduction in number of days per month with headache and shoulders pain after 12 months. [24 months]
Secondary Outcome Measures
- Reduction in number of days per month of drug intake after 12 months [24 months]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Headache and Facial Pain Unit University of Turin | Turin | Italy | I-10126 |
Sponsors and Collaborators
- University of Turin, Italy
- Fondazione CRT, Torino
- Turin, Italy
- Regione Piemonte
Investigators
- Principal Investigator: Franco Mongini, MD, Prof., Headache and Facial Pain Unit Dept. Clinical Pathophysiology University of Turin
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3