Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in Working Communities

Phase 3

Completed

• Conditions: Headache Disorders; Headache; Neck Pain; Shoulder Pain
• Interventions: Behavioral: Cognitive, behavioral, exercise

• Registration Number: NCT00457496
• Lead Sponsor: University of Turin, Italy

Brief Summary

The primary purpose of this study is to evaluate the effectiveness of a workplace cognitive and physical program (Intervention), in reducing the frequency of head and neck pain

Detailed Description

Many studies have been 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.

The primary objective of this study is to evaluate the effectiveness of a workplace cognitive and physical programme (Intervention) in reducing the frequency of pain involving the head and neck area. 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.

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: 2005-03
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Study First Submitted: 2007-04-05
• Study First Submitted QC: 2007-04-05
• Study First Posted: 2007-04-06
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-11
• Last Update Posted: 2008-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Subjects employed at the Municipality of Turin ( Registry-Tax office) from the 1th January 2005 that will give informed consent before starting the study.

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
A	Cognitive, behavioral, exercise	-

Primary Outcome Measures

Name	Time	Method
Frequency of headache and neck and shoulder pain after 6 months (monthly frequency, responder rate)	6 months

Secondary Outcome Measures

Name	Time	Method
Analgesic drug consumption after 6 and 12 months	12 months
Headache index after 6 and 12 months	12 months
Neck and shoulder pain index after 6 and 12 months	12 months
Muscle tenderness at palpation after 6 and 12 months	12 months
Psychiatric comorbidity and psychosomatic symptoms prevalence	12 months
Frequency of pain in head/neck area after 12 months in both groups	12 months