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

July 11, 2008 updated by: University of Turin, Italy

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Behavioral: Cognitive, behavioral, exercise
Relaxation exercises once a day, visual feedback, exercises for neck and shoulder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of headache and neck and shoulder pain after 6 months (monthly frequency, responder rate)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Analgesic drug consumption after 6 and 12 months
Time Frame: 12 months
12 months
Headache index after 6 and 12 months
Time Frame: 12 months
12 months
Neck and shoulder pain index after 6 and 12 months
Time Frame: 12 months
12 months
Muscle tenderness at palpation after 6 and 12 months
Time Frame: 12 months
12 months
Psychiatric comorbidity and psychosomatic symptoms prevalence
Time Frame: 12 months
12 months
Frequency of pain in head/neck area after 12 months in both groups
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Collaborators

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

Investigators

  • Study Chair: Franco Mongini, Professor, University of Turin, Italy
  • Principal Investigator: Luca Ferrero, DDS, University of Turin, Italy
  • Principal Investigator: Alessandro Ugolini, DDS, University of Turin, Italy
  • Principal Investigator: Eugenia Rota, MD, University of Turin, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

April 5, 2007

First Submitted That Met QC Criteria

April 5, 2007

First Posted (Estimate)

April 6, 2007

Study Record Updates

Last Update Posted (Estimate)

July 14, 2008

Last Update Submitted That Met QC Criteria

July 11, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5147SD2003.0271

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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