Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Large Population

July 8, 2010 updated by: University of Turin, Italy

Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Population of an Extensive Territory

This study is an interventional trial to evaluate the effectiveness of a cognitive and physical program (Intervention), in reducing the frequency of head and neck pain in the population of an extensive territory of Italy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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 results were stable at a 12 month follow up. More recently a controlled, cluster randomised, interventional trial was conducted on 1930 local government employees of the Municipality of Turin. The data obtained confirm those of the previous studies.

The present study was designed to confirm the data in a much more extensive population , that is, residents of the Italian Region Piemonte (Piedmont) who will apply to participate.

Primary objective is to confirm the effectiveness of the cognitive and physical programme (Intervention), in reducing the frequency of pain involving the head and neck area in a large population of a territory.

Secondary objective is to confirm the effectiveness of the Intervention, in reducing analgesic drugs consumption after the Intervention in the same population.

Study Type

Interventional

Enrollment (Anticipated)

15000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Turin, Italy, I-10126
        • Recruiting
        • Headache and Facial Pain Unit University of Turin
        • Contact:
        • Principal Investigator:
          • Franco Mongini, MD
        • Sub-Investigator:
          • Chantal Milani, DDS
        • Sub-Investigator:
          • Emanuela Banzatti, DDS
        • Sub-Investigator:
          • Luca Ferrero, DDS
        • Sub-Investigator:
          • Alessandro Ugolini, DDS
        • Sub-Investigator:
          • Alessandro Piedimonte, Dr.

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

15 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All residents of the Region Piemonte (Italy) may apply for recruitment

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: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cognitive and physical program
Experimental: Cognitive and physical program. Non randomized residents in the territory of Piedmont (Piemonte) Italy.
Behavioral: Behavioral: Cognitive, Relaxation, Exercise Therapy
Behavioral: Cognitive, 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in number of days per month with headache and shoulders pain after 12 months.
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction in number of days per month of drug intake after 12 months
Time Frame: 24 months
24 months

Collaborators and Investigators

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

Sponsor

University of Turin, Italy

Collaborators

Regione Piemonte
Fondazione CRT, Torino
Turin, Italy

Investigators

  • Principal Investigator: Franco Mongini, MD, Prof., Headache and Facial Pain Unit Dept. Clinical Pathophysiology University of Turin

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

June 1, 2009

Primary Completion (ANTICIPATED)

June 1, 2011

Study Completion (ANTICIPATED)

November 1, 2011

Study Registration Dates

First Submitted

January 15, 2010

First Submitted That Met QC Criteria

January 15, 2010

First Posted (ESTIMATE)

January 18, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 9, 2010

Last Update Submitted That Met QC Criteria

July 8, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3

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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