Clinical trial NCT00551980: The Efficacy of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Working Community
Official title: Effectiveness of a Workplace Cognitive and Physical Program in Reducing Headache,Neck and Shoulder Pain in an Extensive Working Community. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Tension Type Headache
Cervical Pain
Keywords: Headache
Cervical Pain
Cognitive treatment
Relaxation
Exercise
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: 2007-11-01
Enrollment: 2895
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 12 months
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Headache and Facial Pain Unit University of Turin
Study officials:
affiliation: University of Turin, Italy
name: Franco Mongini, Professor
role: STUDY_CHAIR
affiliation: University of Turin, Italy
name: Chantal Milani, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turin, Italy
name: Luca Ferrero, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turin, Italy
name: Alessandro Ugolini, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turin, Italy
name: Monica Sigaudo, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turin, Italy
name: Elisa Chiorino, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mongini F, Evangelista A, Milani C, Ferrero L, Ciccone G, Ugolini A, Piedimonte A, Sigaudo M, Carlino E, Banzatti E, Galassi C. An educational and physical program to reduce headache, neck/shoulder pain in a working community: a cluster-randomized controlled trial. PLoS One. 2012;7(1):e29637. doi: 10.1371/journal.pone.0029637. Epub 2012 Jan 9.