Headache DisordersPhase 3NCT00457496
Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in Working Communities
A Phase 3 study testing Cognitive, behavioral, exercise in people with Headache Disorders and Headache, run by University of Turin, Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Headache Disorders, Headache, Neck Pain
- What is being tested?
- Cognitive, behavioral, exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Apr 2006
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects employed at the Municipality of Turin ( Registry-Tax office) from the 1th January 2005 that will give informed consent before starting the study.
Who cannot join
- Because of the pragmatic design, no exclusion criteria are required for this study
About this study
Official title: Effectiveness of a Cognitive and Physical Program in Reducing Headache, Neck and Shoulder Pain: a Workplace Controlled Trial
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
Read the detailed description
Many studies have been performed to assess the efficacy of non invasive physical interventions in the treatment of different types of headache and cervical pain. However the evidence on their effectiveness is still limited and the results of recent studies are conflicting.
The primary objective of this study is to evaluate the effectiveness of a workplace cognitive and physical programme (Intervention) in reducing the frequency of pain involving the head and neck area. 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 parafunction and hyperfunction of the craniofacial and cervical muscles during the day.
Comparison(s): Group of employees that will receive a cognitive/physical programme (Intervention), compared to a similar group of employees that will not receive the Intervention (Controls); (frequency of headache and neck and shoulder pain).
- Conditions
- Headache Disorders, Headache, Neck Pain, Shoulder Pain
- Being tested
- Cognitive, behavioral, exercise
- Keywords
- Behavior Therapy, Relaxation Techniques, Cognitive Therapy, Exercise Movement Techniques
- Medical subject headings
- Headache Disorders, Headache, Neck Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive, behavioral, exerciseBehavioural
Relaxation exercises once a day, visual feedback, exercises for neck and shoulder
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Behavioral: Cognitive, behavioral, exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of headache and neck and shoulder pain after 6 months (monthly frequency, responder rate)
Measured: 6 months
Secondary outcomes (6)
Analgesic drug consumption after 6 and 12 months
Measured: 12 months
Headache index after 6 and 12 months
Measured: 12 months
Neck and shoulder pain index after 6 and 12 months
Measured: 12 months
Muscle tenderness at palpation after 6 and 12 months
Measured: 12 months
Psychiatric comorbidity and psychosomatic symptoms prevalence
Measured: 12 months
Frequency of pain in head/neck area after 12 months in both groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startMar 2005
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache DisordersStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Compagnia di San Paolo, Turin, Italy, Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte, Regione Piemonte
- Investigators
- Franco Mongini, Professor, Study chair, University of Turin, ItalyEugenia Rota, MD, Principal investigator, University of Turin, ItalyAlessandro Ugolini, DDS, Principal investigator, University of Turin, ItalyLuca Ferrero, DDS, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457496
- Sponsor's protocol ID
- 5147SD2003.0271
- Status last verified
- Jul 2008
- First submitted
- 5 Apr 2007
- Last updated
- 14 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Cognitive and Physical Program in Reducing Headache, Neck and Shoulder Pain: a Workplace Controlled Trial
- ClinicalTrials.gov ID
- NCT00457496
- Acronym / sponsor ID
- 5147SD2003.0271
- Conditions
- Headache Disorders, Headache, Neck Pain, Shoulder Pain
- Keywords
- Behavior Therapy, Relaxation Techniques, Cognitive Therapy, Exercise Movement Techniques
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- Compagnia di San Paolo, Turin, Italy, Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte, Regione Piemonte
- Study start
- Mar 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 6 Apr 2007 (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.
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
Detailed description
Many studies have been performed to assess the efficacy of non invasive physical interventions in the treatment of different types of headache and cervical pain. However the evidence on their effectiveness is still limited and the results of recent studies are conflicting.
The primary objective of this study is to evaluate the effectiveness of a workplace cognitive and physical programme (Intervention) in reducing the frequency of pain involving the head and neck area. 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 parafunction and hyperfunction of the craniofacial and cervical muscles during the day.
Comparison(s): Group of employees that will receive a cognitive/physical programme (Intervention), compared to a similar group of employees that will not receive the Intervention (Controls); (frequency of headache and neck and shoulder pain).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Behavioral: Cognitive, behavioral, exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects employed at the Municipality of Turin ( Registry-Tax office) from the 1th January 2005 that will give informed consent before starting the study.
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 |
|---|---|---|
| Cognitive, behavioral, exerciseRelaxation exercises once a day, visual feedback, exercises for neck and shoulder | Behavioural | A |
Primary outcome
Frequency of headache and neck and shoulder pain after 6 months (monthly frequency, responder rate)
Time frame: 6 months
6 secondary outcomes
Analgesic drug consumption after 6 and 12 months
Time frame: 12 months
Headache index after 6 and 12 months
Time frame: 12 months
Neck and shoulder pain index after 6 and 12 months
Time frame: 12 months
Muscle tenderness at palpation after 6 and 12 months
Time frame: 12 months
Psychiatric comorbidity and psychosomatic symptoms prevalence
Time frame: 12 months
Frequency of pain in head/neck area after 12 months in both groups
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2008.
Related trials for Headache Disorders
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
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, Professor study chair
University of Turin, Italy
Eugenia Rota, MD principal investigator
University of Turin, Italy
Alessandro Ugolini, DDS principal investigator
University of Turin, Italy
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive, behavioral, exercise in people with Headache Disorders and Headache, run by University of Turin, 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: finished, as of the sponsor's last update on 14 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of headache and neck and shoulder pain after 6 months (monthly frequency, responder rate) (time frame: 6 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 14 Jul 2008.