Physiotherapy Program for Cluster Headache | NCT02460003

Studies
Physiotherapy Program for Cluster Headache

NCT02460003

Sponsor

AG Clinic

Status

Unknown status

Last Update Posted

Jul 31, 2015Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Cluster Headache

Interventions

Physiotherapy
Home exercise program

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Dec 2015Estimated

Completion Date

Jun 2016Estimated

First Submitted Date

May 20, 2015

First Submission Date that Met QC Criteria

May 28, 2015

First Posted Date

Jun 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2015

Last Update Posted Date

Jul 31, 2015Estimated

Name	Class
Instituto de Investigación Hospital Universitario La Paz	OTHER
Hospital Universitario La Paz	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Physiotherapy program	Experimental	Physiotherapy program and usual drugs	Behavioral: Physiotherapy
Home exercise program	Active Comparator	Home exercise program and usual drugs	Other: Home exercise program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physiotherapy	Behavioral	A program of physiotherapy including manual therapy, exercise, pain education.	Physiotherapy program

Measure	Description	Time Frame
Pain Scores on the Visual Analog Scale		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cluster headache diagnosed

Exclusion Criteria:

Other types of headaches.
Neurostimulator implanted.
Other chronic pain processes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alfonso Gil-Martínez, Master	Hospital Universitario La Paz. AGClinic	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AGClinic		Madrid	Madrid	28046	Spain

Label	URL
AGClinic Advanced Physiotherapy	View source

Condition Browse Module

MeSH Terms

ID	Term
D003027	Cluster Headache

Ancestor Terms

ID	Term
D051303	Trigeminal Autonomic Cephalalgias
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D026741	Physical Therapy Modalities
D026201	Musculoskeletal Manipulations
D005081	Exercise Therapy

Ancestor Terms

ID	Term
D013812	Therapeutics
D012046	Rehabilitation
D000529	Complementary Therapies
D000359	Aftercare

Browse Leaves

Not provided

Browse Branches

Not provided