NCT02460003

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

8 months

First QC Date

May 20, 2015

Last Update Submit

July 30, 2015

Conditions

Cluster Headache

Outcome Measures

Primary Outcomes (1)

  • Pain Scores on the Visual Analog Scale

    3 months

Study Arms (2)

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

PhysiotherapyBEHAVIORAL

A program of physiotherapy including manual therapy, exercise, pain education.

Also known as: Manual Therapy, Physical Therapy
Physiotherapy program
Home exercise programOTHER

Home exercise program

Also known as: Therapeutic exercise
Home exercise program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cluster headache diagnosed

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AGClinic

Madrid, Madrid, 28046, Spain

Location

Related Links

MeSH Terms

Conditions

Cluster Headache

Interventions

Physical Therapy ModalitiesMusculoskeletal ManipulationsExercise Therapy

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationComplementary TherapiesAftercareContinuity of Patient CarePatient Care

Study Officials

  • Alfonso Gil-Martínez, Master

    Hospital Universitario La Paz. AGClinic

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2015

First Posted

June 2, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

ES(1)