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

Phase 3

Completed

• Conditions: Migraine; Tension Type Headache; Cervical Pain
• Interventions: Behavioral: Cognitive, Relaxation, Exercise Therapy

• Registration Number: NCT00551980
• Lead Sponsor: University of Turin, Italy

Brief Summary

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.

Detailed 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).

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-31
• Study First Submitted QC: 2007-10-31
• Study First Posted: 2007-11-01
• Primary Completion: 2009-06
• Status Verified: 2009-11
• Study Completion: 2009-11
• Last Update Submitted: 2009-11-12
• Last Update Posted: 2009-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2895

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive and physical program	Cognitive, Relaxation, Exercise Therapy	Randomized group of workers of the same institution ( City of Turin, Italy).

Primary Outcome Measures

Name	Time	Method
Reduction in number of days per month with headache and shoulders pain after 6 months.Proportion of subjects with more than 4 days with headache and shoulder pain at the baseline that will have reduction in pain frequency of more than 50%, after 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Headache index (Intensity x Frequency) after 6 and 12 months. Frequency of analgesic drug consumption after 6 and 12 months Frequency of headache and shoulder pain after 12 months	12 months

Trial Locations

Locations (1)

Headache and Facial Pain Unit University of Turin; 🇮🇹 Torino, Italy