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

University of Turin, Italy300 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Headache Disorders Headache Neck Pain Shoulder Pain

Interventions

Cognitive, behavioral, exerciseBEHAVIORAL

Relaxation exercises once a day, visual feedback, exercises for neck and shoulder

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

Analgesic drug consumption after 6 and 12 months

Time frame: 12 months

Headache index after 6 and 12 months

Time frame: 12 months

Neck and shoulder pain index after 6 and 12 months

Time frame: 12 months

Muscle tenderness at palpation after 6 and 12 months

Time frame: 12 months

Psychiatric comorbidity and psychosomatic symptoms prevalence

Time frame: 12 months

Frequency of pain in head/neck area after 12 months in both groups

Time frame: 12 months

Data from ClinicalTrials.gov

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