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

Effectiveness of a Workplace Cognitive and Physical Program in Reducing Headache,Neck and Shoulder Pain in an Extensive Working Community. A Randomized Controlled Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00551980
Enrollment
2895
Registered
2007-11-01
Start date
2007-10-31
Completion date
2009-11-30
Last updated
2009-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Pain, Migraine, Tension Type Headache

Keywords

Headache, Cervical Pain, Cognitive treatment, Relaxation, Exercise

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).

Interventions

BEHAVIORALCognitive, Relaxation, Exercise Therapy

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 hyperfunction of the craniofacial and cervical muscles during the day

Sponsors

Compagnia di San Paolo
CollaboratorOTHER
Turin, Italy
CollaboratorOTHER
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
CollaboratorOTHER
Regione Piemonte
CollaboratorOTHER
University of Turin, Italy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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 months6 months

Secondary

MeasureTime frame
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 months12 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026