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

This study has been completed.
Sponsor:
Collaborators:
Compagnia di San Paolo
Turin, Italy
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Regione Piemonte
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT00457496
First received: April 5, 2007
Last updated: July 11, 2008
Last verified: July 2008
  Purpose

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


Condition Intervention Phase
Headache Disorders
Headache
Neck Pain
Shoulder Pain
Behavioral: Cognitive, behavioral, exercise
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of a Cognitive and Physical Program in Reducing Headache, Neck and Shoulder Pain: a Workplace Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • Frequency of headache and neck and shoulder pain after 6 months (monthly frequency, responder rate) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analgesic drug consumption after 6 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Headache index after 6 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Neck and shoulder pain index after 6 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Muscle tenderness at palpation after 6 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Psychiatric comorbidity and psychosomatic symptoms prevalence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Frequency of pain in head/neck area after 12 months in both groups [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: March 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Behavioral: Cognitive, behavioral, exercise
Relaxation exercises once a day, visual feedback, exercises for neck and shoulder

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457496

Sponsors and Collaborators
University of Turin, Italy
Compagnia di San Paolo
Turin, Italy
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Regione Piemonte
Investigators
Study Chair: Franco Mongini, Professor University of Turin
Principal Investigator: Eugenia Rota, MD University of Turin
Principal Investigator: Alessandro Ugolini, DDS University of Turin
Principal Investigator: Luca Ferrero, DDS University of Turin
  More Information

No publications provided

Responsible Party: Franco Mongini/ Professor and Chairman, Unit of Headache and Facial Pain, Dept. of Clinical Pathophysiology
ClinicalTrials.gov Identifier: NCT00457496     History of Changes
Other Study ID Numbers: 5147SD2003.0271
Study First Received: April 5, 2007
Last Updated: July 11, 2008
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by University of Turin, Italy:
Behavior Therapy
Relaxation Techniques
Cognitive Therapy
Exercise Movement Techniques

Additional relevant MeSH terms:
Headache
Shoulder Pain
Headache Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014