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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01050972

Enrollment

15000

Registered

2010-01-18

Start date

2009-06-30

Completion date

2011-11-30

Last updated

2010-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Pain, Migraine, Tension Type Headache

Keywords

Headache, Cervical Pain, Cognitive treatment, Relaxation, Exercise

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.

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.

Interventions

BEHAVIORALBehavioral: 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Because of the pragmatic design, no

Design outcomes

Primary

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

Secondary

Measure	Time frame
Reduction in number of days per month of drug intake after 12 months	24 months

Countries

Italy

Contacts

Primary ContactFranco Mongini, Professor

franco.mongini@unito.it00390116334041

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026