The Efficacy of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Working Community

University of Turin

Status and phase: Completed; Phase 3

Conditions: Cervical Pain; Migraine; Tension Type Headache

Treatments: Behavioral: Cognitive, Relaxation, Exercise Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00551980

1130SD2006.1911

Details and patient eligibility

About

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.

Full 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).

Enrollment: 2,895 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,895 participants in 2 patient groups

Cognitive and physical program

Experimental group

Description:

Randomized group of workers of the same institution ( City of Turin, Italy).

Treatment:

Behavioral: Cognitive, Relaxation, Exercise Therapy

Control group

No Intervention group

Description:

Randomized group of workers of the same institution ( City of Turin, Italy).