Back to resultsPhysiotherapy Program for Cluster Headache (PhyCH)
Primary Purpose
Cluster Headache
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physiotherapy
Home exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Cluster Headache
Eligibility Criteria
Inclusion Criteria:
- Cluster headache diagnosed
Exclusion Criteria:
- Other types of headaches.
- Neurostimulator implanted.
- Other chronic pain processes
Sites / Locations
- AGClinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Physiotherapy program
Home exercise program
Arm Description
Physiotherapy program and usual drugs
Home exercise program and usual drugs
Outcomes
Primary Outcome Measures
Pain Scores on the Visual Analog Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT02460003
First Posted
May 20, 2015
Last Updated
July 30, 2015
Sponsor
AG Clinic
Collaborators
Instituto de Investigación Hospital Universitario La Paz, Hospital Universitario La Paz
1. Study Identification
Unique Protocol Identification Number
NCT02460003
Brief Title
Physiotherapy Program for Cluster Headache
Acronym
PhyCH
Official Title
Effectiveness of Physiotherapy Program in Patients With Cluster Headache
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AG Clinic
Collaborators
Instituto de Investigación Hospital Universitario La Paz, Hospital Universitario La Paz
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cluster Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physiotherapy program
Arm Type
Experimental
Arm Description
Physiotherapy program and usual drugs
Arm Title
Home exercise program
Arm Type
Active Comparator
Arm Description
Home exercise program and usual drugs
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapy
Other Intervention Name(s)
Manual Therapy, Physical Therapy
Intervention Description
A program of physiotherapy including manual therapy, exercise, pain education.
Intervention Type
Other
Intervention Name(s)
Home exercise program
Other Intervention Name(s)
Therapeutic exercise
Intervention Description
Home exercise program
Primary Outcome Measure Information:
Title
Pain Scores on the Visual Analog Scale
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cluster headache diagnosed
Exclusion Criteria:
Other types of headaches.
Neurostimulator implanted.
Other chronic pain processes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfonso Gil-Martínez, Master
Organizational Affiliation
Hospital Universitario La Paz. AGClinic
Official's Role
Study Director
Facility Information:
Facility Name
AGClinic
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Physiotherapy Program for Cluster Headache
We'll reach out to this number within 24 hrs