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Completed

NCT Number: NCT00551980

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

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.

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Key information

Conditions

Migraine Behavior Brain Diseases Central Nervous System Diseases Cervical Pain Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Motor Activity Neck Pain Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Tension Type Headache Tension-Type Headache

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Headache and Facial Pain Unit University of Turin

Torino, I-10126, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive, Relaxation, Exercise Therapy

Behavioral

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

Primary outcomes

  1. 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

    Time frame: 6 months

Secondary outcomes

  1. 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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Collaborators

  • Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
  • Compagnia di San Paolo
  • Regione Piemonte
  • Turin, Italy

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 1, 2007
Registry last updated
Nov 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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