NCT01050972

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

July 9, 2010

Status Verified

July 1, 2010

Enrollment Period

2 years

First QC Date

January 15, 2010

Last Update Submit

July 8, 2010

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 12 months.

    24 months

Secondary Outcomes (1)

  • Reduction in number of days per month of drug intake after 12 months

    24 months

Study Arms (1)

Cognitive and physical program

EXPERIMENTAL

Experimental: Cognitive and physical program. Non randomized residents in the territory of Piedmont (Piemonte) Italy.

Behavioral: Behavioral: Cognitive, Relaxation, Exercise Therapy

Interventions

Behavioral: Cognitive, Relaxation, Exercise TherapyBEHAVIORAL

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

Cognitive and physical program

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Headache and Facial Pain Unit University of Turin

Turin, I-10126, Italy

RECRUITING

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, MD, Prof.

    Headache and Facial Pain Unit Dept. Clinical Pathophysiology University of Turin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Franco Mongini, Professor

CONTACT

00390116334041franco.mongini@unito.it

Study Design

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

Study Record Dates

First Submitted

January 15, 2010

First Posted

January 18, 2010

Study Start

June 1, 2009

Primary Completion

June 1, 2011

Study Completion

November 1, 2011

Last Updated

July 9, 2010

Record last verified: 2010-07

Locations

IT(1)