NCT00457496

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2007

Completed
Last Updated

July 14, 2008

Status Verified

July 1, 2008

Enrollment Period

1.1 years

First QC Date

April 5, 2007

Last Update Submit

July 11, 2008

Conditions

Headache DisordersHeadacheNeck PainShoulder Pain

Keywords

Behavior TherapyRelaxation TechniquesCognitive TherapyExercise Movement Techniques

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (6)

  • Analgesic drug consumption after 6 and 12 months

    12 months

  • Headache index after 6 and 12 months

    12 months

  • Neck and shoulder pain index after 6 and 12 months

    12 months

  • Muscle tenderness at palpation after 6 and 12 months

    12 months

  • Psychiatric comorbidity and psychosomatic symptoms prevalence

    12 months

  • +1 more secondary outcomes

Study Arms (1)

A

ACTIVE COMPARATOR
Behavioral: Cognitive, behavioral, exercise

Interventions

Cognitive, behavioral, exerciseBEHAVIORAL

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

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects employed at the Municipality of Turin ( Registry-Tax office) from the 1th January 2005 that will give informed consent before starting the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Headache DisordersHeadacheNeck PainShoulder Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthralgiaJoint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Franco Mongini, Professor

    University of Turin, Italy

    STUDY CHAIR

  • Eugenia Rota, MD

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

  • Alessandro Ugolini, DDS

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

  • Luca Ferrero, DDS

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 5, 2007

First Posted

April 6, 2007

Study Start

March 1, 2005

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

July 14, 2008

Record last verified: 2008-07