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Completed

NCT Number: NCT00457496

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

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

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Key information

Conditions

Headache Disorders Arthralgia Brain Diseases Central Nervous System Diseases Headache Joint Diseases Musculoskeletal Diseases Neck Pain Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Cognitive, behavioral, exercise

Behavioral

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

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. Analgesic drug consumption after 6 and 12 months

    Time frame: 12 months

  2. Headache index after 6 and 12 months

    Time frame: 12 months

  3. Neck and shoulder pain index after 6 and 12 months

    Time frame: 12 months

  4. Muscle tenderness at palpation after 6 and 12 months

    Time frame: 12 months

  5. Psychiatric comorbidity and psychosomatic symptoms prevalence

    Time frame: 12 months

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

    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 Cognitive and Physical Program in Reducing Headache, Neck and Shoulder Pain: a Workplace Controlled Trial

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Apr 6, 2007
Registry last updated
Jul 14, 2008

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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