Cluster HeadachePhyCHNCT02460003
Physiotherapy Program for Cluster Headache
A study testing Physiotherapy and Home exercise program in people with Cluster Headache, run by AG Clinic at 1 site in Spain.
Trial summary
This study evaluates the effectiveness of physiotherapy program in the treatment of cluster headaches. Half of participants will receive a program of physiotherapy and usual drugs, while the other will receive an exercise program and usual drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cluster Headache
- What is being tested?
- Physiotherapy and Home exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2015to Jun 2016
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cluster headache diagnosed
Who cannot join
- Other types of headaches.
- Neurostimulator implanted.
- Other chronic pain processes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Physiotherapy Program in Patients With Cluster Headache
This study evaluates the effectiveness of physiotherapy program in the treatment of cluster headaches. Half of participants will receive a program of physiotherapy and usual drugs, while the other will receive an exercise program and usual drugs.
Read the detailed description
Previous studies have shown positive effects of physical therapy in patients with primary headache.
However, so far no study that assessed the effect of a physiotherapy program combined with regular medication in patients with cluster headache.
- Conditions
- Cluster Headache
- Being tested
- Physiotherapy, Home exercise program
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyBehavioural
Also called Manual Therapy, Physical Therapy
A program of physiotherapy including manual therapy, exercise, pain education.
Home exercise programOther
Also called Therapeutic exercise
Home exercise program
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy program | Experimental | Physiotherapy program and usual drugs Receives: Behavioral: Physiotherapy |
| Home exercise program | Active comparator | Home exercise program and usual drugs Receives: Other: Home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores on the Visual Analog Scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster HeadacheStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AG Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Hospital Universitario La Paz, Hospital Universitario La Paz
- Responsible party
- Sponsor
- Investigators
- Alfonso Gil-Martínez, Master, Study director, Hospital Universitario La Paz. AGClinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460003
- Sponsor's protocol ID
- CH-Physiotherapy
- Acronym
- PhyCH
- Status last verified
- Jul 2015
- First submitted
- 20 May 2015
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physiotherapy Program in Patients With Cluster Headache
- ClinicalTrials.gov ID
- NCT02460003
- Acronym / sponsor ID
- PhyCH / CH-Physiotherapy
- Conditions
- Cluster Headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AG ClinicUniversity, hospital or other
- Collaborators
- Instituto de Investigación Hospital Universitario La Paz, Hospital Universitario La Paz
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 2 Jun 2015 (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 evaluates the effectiveness of physiotherapy program in the treatment of cluster headaches. Half of participants will receive a program of physiotherapy and usual drugs, while the other will receive an exercise program and usual drugs.
Detailed description
Previous studies have shown positive effects of physical therapy in patients with primary headache.
However, so far no study that assessed the effect of a physiotherapy program combined with regular medication in patients with cluster headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy program | Experimental | Behavioral: PhysiotherapyPhysiotherapy program and usual drugs |
| Home exercise program | Active comparator | Other: Home exercise programHome exercise program and usual drugs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cluster headache diagnosed
Key exclusion criteria (3 listed)
- Other types of headaches.
- Neurostimulator implanted.
- Other chronic pain processes
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 |
|---|---|---|
| PhysiotherapyAlso: Manual Therapy, Physical TherapyA program of physiotherapy including manual therapy, exercise, pain education. | Behavioural | Physiotherapy program |
| Home exercise programAlso: Therapeutic exerciseHome exercise program | Other | Home exercise program |
Primary outcome
Pain Scores on the Visual Analog Scale
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
- AGClinic Advanced PhysiotherapyLink provided by the sponsor.
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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.
Alfonso Gil-Martínez, Master study director
Hospital Universitario La Paz. AGClinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy and Home exercise program in people with Cluster Headache, run by AG Clinic at 1 site in Spain.
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 3 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 31 Jul 2015. 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 Spain. 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.
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?
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?
Pain Scores on the Visual Analog Scale (time frame: 3 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 31 Jul 2015.