Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Large Population

University of Turin

Status and phase: Unknown; Phase 3

Conditions: Cervical Pain; Migraine; Tension Type Headache

Treatments: Behavioral: Behavioral: Cognitive, Relaxation, Exercise Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01050972

3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15,000 estimated patients

Sex: All

Ages: 15 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15,000 participants in 1 patient group

Cognitive and physical program

Experimental group

Description:

Experimental: Cognitive and physical program. Non randomized residents in the territory of Piedmont (Piemonte) Italy.

Treatment:

Behavioral: Behavioral: Cognitive, Relaxation, Exercise Therapy