NCT00551980

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,895

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

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

October 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

November 13, 2009

Status Verified

November 1, 2009

Enrollment Period

1.7 years

First QC Date

October 31, 2007

Last Update Submit

November 12, 2009

Conditions

MigraineTension Type HeadacheCervical Pain

Keywords

HeadacheCervical PainCognitive treatmentRelaxationExercise

Outcome Measures

Primary Outcomes (1)

  • Reduction in number of days per month with headache and shoulders pain after 6 months.Proportion of subjects with more than 4 days with headache and shoulder pain at the baseline that will have reduction in pain frequency of more than 50%, after 6 months

    6 months

Secondary Outcomes (1)

  • Headache index (Intensity x Frequency) after 6 and 12 months. Frequency of analgesic drug consumption after 6 and 12 months Frequency of headache and shoulder pain after 12 months

    12 months

Study Arms (2)

Cognitive and physical program

EXPERIMENTAL

Randomized group of workers of the same institution ( City of Turin, Italy).

Behavioral: Cognitive, Relaxation, Exercise Therapy

Control group

NO INTERVENTION

Randomized group of workers of the same institution ( City of Turin, Italy).

Interventions

Cognitive, Relaxation, Exercise TherapyBEHAVIORAL

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

Cognitive and physical program

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All the subjects employed at the Municipality of Turin at September, 2007 will be recruited.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Headache and Facial Pain Unit University of Turin

Torino, I-10126, Italy

Location

Related Publications (1)

  • Mongini F, Evangelista A, Milani C, Ferrero L, Ciccone G, Ugolini A, Piedimonte A, Sigaudo M, Carlino E, Banzatti E, Galassi C. An educational and physical program to reduce headache, neck/shoulder pain in a working community: a cluster-randomized controlled trial. PLoS One. 2012;7(1):e29637. doi: 10.1371/journal.pone.0029637. Epub 2012 Jan 9.

    PMID: 22253751DERIVED

MeSH Terms

Conditions

Migraine DisordersTension-Type HeadacheNeck PainHeadacheMotor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Franco Mongini, Professor

    University of Turin, Italy

    STUDY CHAIR

  • Chantal Milani, DDS

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

  • Luca Ferrero, DDS

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

  • Alessandro Ugolini, DDS

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

  • Monica Sigaudo, DDS

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

  • Elisa Chiorino, Dr

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 31, 2007

First Posted

November 1, 2007

Study Start

October 1, 2007

Primary Completion

June 1, 2009

Study Completion

November 1, 2009

Last Updated

November 13, 2009

Record last verified: 2009-11

Locations

IT(1)