Clinical trial NCT00457496: Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in Working Communities
Official title: Effectiveness of a Cognitive and Physical Program in Reducing Headache, Neck and Shoulder Pain: a Workplace Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Headache Disorders
Headache
Neck Pain
Shoulder Pain
Keywords: Behavior Therapy
Relaxation Techniques
Cognitive Therapy
Exercise Movement Techniques
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: Compagnia di San Paolo
name: Turin, Italy
name: Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
name: Regione Piemonte
First posted: 2007-04-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of headache and neck and shoulder pain after 6 months (monthly frequency, responder rate)
timeFrame: 6 months
Secondary outcomes:
measure: Analgesic drug consumption after 6 and 12 months
timeFrame: 12 months
measure: Headache index after 6 and 12 months
timeFrame: 12 months
measure: Neck and shoulder pain index after 6 and 12 months
timeFrame: 12 months
measure: Muscle tenderness at palpation after 6 and 12 months
timeFrame: 12 months
measure: Psychiatric comorbidity and psychosomatic symptoms prevalence
timeFrame: 12 months
measure: Frequency of pain in head/neck area after 12 months in both groups
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Turin, Italy
name: Franco Mongini, Professor
role: STUDY_CHAIR
affiliation: University of Turin, Italy
name: Eugenia Rota, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turin, Italy
name: Alessandro Ugolini, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turin, Italy
name: Luca Ferrero, DDS
role: PRINCIPAL_INVESTIGATOR
References: