MigrainePhase 3NCT01050972
Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Large Population
A Phase 3 study testing Behavioral: Cognitive, Relaxation, Exercise Therapy in people with Migraine and Tension Type Headache, run by University of Turin, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine, Tension Type Headache, Cervical Pain
- What is being tested?
- Behavioral: Cognitive, Relaxation, Exercise Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,000 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2009to Nov 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All residents of the Region Piemonte (Italy) may apply for recruitment
Who cannot join
- Because of the pragmatic design, no exclusion criteria are required for this study
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Headache and Facial Pain Unit University of Turin
Turin, I-10126
Franco Mongini, Professor, 00390116334041, franco.mongini@unito.it
Franco Mongini, MD
About this study
Official title: Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Population of an Extensive Territory
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.
Read the 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.
- Conditions
- Migraine, Tension Type Headache, Cervical Pain
- Being tested
- Behavioral: Cognitive, Relaxation, Exercise Therapy
- Keywords
- Headache, Cervical Pain, Cognitive treatment, Relaxation, Exercise
- Medical subject headings
- Migraine Disorders, Tension-Type Headache, Neck Pain, Headache, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Cognitive, Relaxation, Exercise TherapyBehavioural
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 group | Role | What they receive |
|---|---|---|
| Cognitive and physical program | Experimental | Experimental: Cognitive and physical program. Non randomized residents in the territory of Piedmont (Piemonte) Italy. Receives: Behavioral: Behavioral: Cognitive, Relaxation, Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in number of days per month with headache and shoulders pain after 12 months.
Measured: 24 months
Secondary outcomes (1)
Reduction in number of days per month of drug intake after 12 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startJun 2009
- Primary completionJun 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione CRT, Torino, Turin, Italy, Regione Piemonte
- Investigators
- Franco Mongini, MD, Prof., Principal investigator, Headache and Facial Pain Unit Dept. Clinical Pathophysiology University of Turin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050972
- Sponsor's protocol ID
- 3
- Status last verified
- Jul 2010
- First submitted
- 15 Jan 2010
- Last updated
- 9 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Population of an Extensive Territory
- ClinicalTrials.gov ID
- NCT01050972
- Acronym / sponsor ID
- 3
- Conditions
- Migraine, Tension Type Headache, Cervical Pain
- Keywords
- Headache, Cervical Pain, Cognitive treatment, Relaxation, Exercise
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- Fondazione CRT, Torino, Turin, Italy, Regione Piemonte
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 18 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive and physical program | Experimental | Behavioral: Behavioral: Cognitive, Relaxation, Exercise TherapyExperimental: Cognitive and physical program. Non randomized residents in the territory of Piedmont (Piemonte) Italy. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All residents of the Region Piemonte (Italy) may apply for recruitment
Key exclusion criteria (1 listed)
- Because of the pragmatic design, no exclusion criteria are required for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral: Cognitive, Relaxation, Exercise TherapyBehavioral: 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 | Behavioural | Cognitive and physical program |
Primary outcome
Reduction in number of days per month with headache and shoulders pain after 12 months.
Time frame: 24 months
1 secondary outcome
Reduction in number of days per month of drug intake after 12 months
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franco Mongini, MD, Prof. principal investigator
Headache and Facial Pain Unit Dept. Clinical Pathophysiology University of Turin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Behavioral: Cognitive, Relaxation, Exercise Therapy in people with Migraine and Tension Type Headache, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Franco Mongini, Professor (00390116334041, franco.mongini@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in number of days per month with headache and shoulders pain after 12 months. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2010.