search
Back to results

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

Primary Purpose

Headache Disorders, Headache, Neck Pain

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Cognitive, behavioral, exercise
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache Disorders focused on measuring Behavior Therapy, Relaxation Techniques, Cognitive Therapy, Exercise Movement Techniques

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Active Comparator

    Arm Label

    A

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 5, 2007
    Last Updated
    July 11, 2008
    Sponsor
    University of Turin, Italy
    Collaborators
    Compagnia di San Paolo, Turin, Italy, Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte, Regione Piemonte
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00457496
    Brief Title
    Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in Working Communities
    Official Title
    Effectiveness of a Cognitive and Physical Program in Reducing Headache, Neck and Shoulder Pain: a Workplace Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    April 2006 (Actual)
    Study Completion Date
    April 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Turin, Italy
    Collaborators
    Compagnia di San Paolo, Turin, Italy, Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte, Regione Piemonte

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Headache Disorders, Headache, Neck Pain, Shoulder Pain
    Keywords
    Behavior Therapy, Relaxation Techniques, Cognitive Therapy, Exercise Movement Techniques

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    300 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Active Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive, behavioral, exercise
    Intervention Description
    Relaxation exercises once a day, visual feedback, exercises for neck and shoulder
    Primary Outcome Measure Information:
    Title
    Frequency of headache and neck and shoulder pain after 6 months (monthly frequency, responder rate)
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Analgesic drug consumption after 6 and 12 months
    Time Frame
    12 months
    Title
    Headache index after 6 and 12 months
    Time Frame
    12 months
    Title
    Neck and shoulder pain index after 6 and 12 months
    Time Frame
    12 months
    Title
    Muscle tenderness at palpation after 6 and 12 months
    Time Frame
    12 months
    Title
    Psychiatric comorbidity and psychosomatic symptoms prevalence
    Time Frame
    12 months
    Title
    Frequency of pain in head/neck area after 12 months in both groups
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Franco Mongini, Professor
    Organizational Affiliation
    University of Turin, Italy
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Eugenia Rota, MD
    Organizational Affiliation
    University of Turin, Italy
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Alessandro Ugolini, DDS
    Organizational Affiliation
    University of Turin, Italy
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Luca Ferrero, DDS
    Organizational Affiliation
    University of Turin, Italy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs