Biobehavioral Physical Therapy Strategies Based on Therapeutic Exercise Applied to Chronic Migraine Patients

October 20, 2021 updated by: Paula Kindelan, Universidad Autonoma de Madrid
The purpose of this study is to know wich combination of treatments are the most effective in patients with chronic migraine. The study design is a simple blind randomized controlled trial (outcomes assessor). The study population: Men and women aged from 18 to 70 years old with chronic migraine for at least 12 weeks. Interventions: A combination of techniques during 6 weeks (6 sessions; 1 per week)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Migraine is a neurological disease characterized by attacks of pulsating headache on one side of the head, presenting autonomic nervous system disfunction. Migraine is associated to significant personal and social burden. Physical activity could worsen patient´s symptoms. Migraine is associated with nausea, vomiting, photophobia and phonophobia Chronic migraine patients according to the third IHS ( International Headache Society) classification suffer headache at least 15 days per month no less than 3 months.

According to Pozo-Rosich et al., migraine incidence worldwide is 2% of the general population. In the US the 18% of migraine patients are females corresponding the 6% to males.

As comorbid diseases usually associated to migraine are found disability, depression, anxiety and biobehavioral disorders. Migraine is a chronic disease which cause biopsychosocial damage and decrease quality of life in its patients. Risk factors to endure Migraine are sex (females), obesity and overuse of headache medicaments.

Migraine origin and its physiopathology in unknown although there are several studies that support a central sensitization mechanism at the level of trigeminocervical complex to explain migraine. Trigeminocervical complex is made by the convergence between superior neurons of the trigeminal nucleus caudalis and the dorsal cervical horns of the first and second cervical levels.

Some authors suggest that it is a biobehavioral disorder that results from a cortical hypersensitivity and an associated social learning process. Behavioral habits and medication intake due to migraine attacks are important factors to keep in mind. Stanos et al. concluded that the best treatment for chronic migraine was a multidisciplinary treatment including biobehavioral and pharmacological approaches. Biobehavioral treatments (BBTs) for chronic pain patients includes therapeutic patient education (TPE) and selfcare, cognitive behavioral interventions, and biobehavioral training (biofeedback, relaxation training, and stress management).

TPE provides contact between the care providers and patients. TPE has been extensively studied in the management of anxiety, stress, and pain for chronic lower back pain. It is thought that in chronic diseases, TPE should be adapted to the needs of patients and caregivers. BBTs were identified as "grade A" evidence in the American Consortium of Evidence Based Headache Guidelines. It has been proposed that BBT based on educational approaches be used to manage migraines.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28003
        • Unidad de Ciencias Neurológicas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • subjects diagnosed with chronic migraine
  • Neck, shoulder or spine pain for at least 12 weeks
  • Continuous headache may be chronic daily headache or tension headache
  • Patients having the willing to undergo the treatment

Exclusion Criteria:

  • Patients undergoing physical another therapy treatment in cervical or head areas.
  • Patient with degenerative neurological syndrome or fibromyalgia
  • Patients with severe cognitive impairment
  • Patients undergo any neck, head or shoulder surgical process

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: NO Intervention Control group
No therapeutic intervention are being giving to the group of patients, they only will have their Neurologist previously prescribed pharmacological treatment.
Other: No intervention
No intervention consist on measure the whole variables in chronic migraine patients to compare it with experimental interventions
Other Names:
  • NI
Experimental: Therapeutic exercise( TE)
The intervention giving to the patients consist on a therapeutic exercise protocol based on neck and low intensity general exercises.
Other: Therapeutic exercise
Therapeutic exercise consist on stretch of cervical-scapular muscles ( Trapezius and angular of the scapula), Cranium-cervical flexor stabilization exercise, auto cervical tractions, shoulders rotation, low intensity exercise ( walking), craniocervical extension, cervical flexion and extension.
Other Names:
  • TE
Experimental: Therapeutic patient education ( TPE)
The intervention giving to the patients consist on a therapeutic patient education based on pain neurophysiology protocol.
Behavioral: Therapeutic patient education
Therapeutic patient education based on pain physiology from a biobehavioral perspective adding a training in coping strategies.
Other Names:
  • TPE
Experimental: TE + TPE
The intervention giving to the patients consist on the combination of the therapeutic exercise protocol and the therapeutic patient education protocol.
Other: Therapeutic exercise
Therapeutic exercise consist on stretch of cervical-scapular muscles ( Trapezius and angular of the scapula), Cranium-cervical flexor stabilization exercise, auto cervical tractions, shoulders rotation, low intensity exercise ( walking), craniocervical extension, cervical flexion and extension.
Other Names:
  • TE
Behavioral: Therapeutic patient education
Therapeutic patient education based on pain physiology from a biobehavioral perspective adding a training in coping strategies.
Other Names:
  • TPE
Experimental: TE + TPE + Manual therapy
The intervention giving to the patients consist on the combination of the therapeutic exercise protocol and the therapeutic patient education protocol plus a manual therapy techniques protocol.
Other: Therapeutic exercise
Therapeutic exercise consist on stretch of cervical-scapular muscles ( Trapezius and angular of the scapula), Cranium-cervical flexor stabilization exercise, auto cervical tractions, shoulders rotation, low intensity exercise ( walking), craniocervical extension, cervical flexion and extension.
Other Names:
  • TE
Behavioral: Therapeutic patient education
Therapeutic patient education based on pain physiology from a biobehavioral perspective adding a training in coping strategies.
Other Names:
  • TPE
Other: Manual Therapy
Manual therapy consist on ; oscillatory traction , maintained craniocervical traction, upper cervical flexion mobilization, side glide roll, anterior-posterior upper cervical mobilization with wedge, lateral glide at the C1-C2 and C2-C3 levels, retraction technique, trigeminocervical neural mobilization , and upper cervical traction, followed by posterior-anterior glide at C4.
Other Names:
  • MT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life measured by the HIT-6 Questionnaire
Time Frame: Baseline
A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral and social environment; the overall condition of a human life.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical range of Motion measured by CROM ( cervical range of motion device)
Time Frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
The distance and direction to which a bone joint can be extended. Range of motion is a function of the condition of the joints, muscles, and connective tissues involved. Joint flexibility can be improved through appropriate MUSCLE STRETCHING EXERCISES.
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Temporal Summation measured by Von Frey filament
Time Frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Postsynaptic Potential Summation: Physiological integration of multiple SYNAPTIC POTENTIAL signals to reach the threshold and initiate postsynaptic ACTION POTENTIALS. In spatial summation stimulations from additional synaptic junctions are recruited to generate s response. In temporal summation succeeding stimuli signals are summed up to reach the threshold. The postsynaptic potentials can be either excitatory or inhibitory (EPSP or IPSP).)
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Sleep Disorders measured by Latineen index score
Time Frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Conditions characterized by disturbances of usual sleep patterns or behaviors. Sleep disorders may be divided into three major categories: DYSSOMNIAS (i.e. disorders characterized by insomnia or hypersomnia), PARASOMNIAS (abnormal sleep behaviors), and sleep disorders secondary to medical or psychiatric disorders
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Medication Adherence scored by a medication calendar
Time Frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Voluntary cooperation of the patient in taking drugs or medicine as prescribed. This includes timing, dosage, and frequency
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Cope (Adaptation, Psychological) measured by CADC questionnaire ( Adaptation of the Chronic Pain self-efficacy Scale) and CAD- R questionnaire
Time Frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
A state of harmony between internal needs and external demands and the processes used in achieving this condition
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Anxiety measured by EUROQOL score
Time Frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Feeling or emotion of dread, apprehension, and impending disaster but not disabling as with ANXIETY DISORDERS.
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Catastrophization measured by PCS ( Pain Catastrophizing Scale)
Time Frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Cognitive and emotional processes encompassing magnification of pain-related stimuli, feelings of helplessness, and a generally pessimistic orientation.
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Phobic Disorders measured by Chronic Pain self-efficacy Scale, BECK
Time Frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Anxiety disorders in which the essential feature is persistent and irrational fear of a specific object, activity, or situation that the individual feels compelled to avoid. The individual recognizes the fear as excessive or unreasonable.
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Disability Evaluation measured by neck disability Index and CF-PDI ( Craniofacial pain and disability inventory)
Time Frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year

Determination of the degree of a physical, mental, or emotional handicap. The diagnosis is applied to legal qualification for benefits and income under disability insurance and to eligibility for Social Security and workmen's compensation benefits.

Determination of the degree of a physical, mental, or emotional handicap. The diagnosis is applied to legal qualification for benefits and income under disability insurance and to eligibility for Social Security and workmen's compensation benefits.

Determination of the degree of a physical, mental, or emotional handicap. The diagnosis is applied to legal qualification for benefits and income under disability insurance and to eligibility for Social Security and workmen's compensation benefits.
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Self Efficacy measured by Chronic Pain self-efficacy Scale
Time Frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Cognitive mechanism based on expectations or beliefs about one's ability to perform actions necessary to produce a given effect. It is also a theoretical component of behavior change in various therapeutic treatments.
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Pain perception outcome assessed by VAS
Time Frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
The process by which PAIN is recognized and interpreted by the brain.
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Quality of Life measured by the HIT-6 Questionnaire
Time Frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral and social environment; the overall condition of a human life.
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Physical activity measured by IPAQ ( International physical Activity questionnaire)
Time Frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
The performance of the basic activities of self care or sport such as dressing, ambulation, eating, walking or practicing sports.
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Pain Threshold measured by algometer
Time Frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Amount of stimulation required before the sensation of pain is experienced.
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Pain behaviour assessed by PBQ questionnaire ( Pain behaviour questionnaire)
Time Frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
The process by which PAIN is recognized and interpreted by the brain.
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Kinesiophobia measured by TSK ( Tampa Scale of Kinesiophobia)
Time Frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Fear of having a painfull experience due to mevement
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Madrid

Investigators

  • Principal Investigator: Paula Kindelan, MSc, associate professor Universidad Autónoma de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

May 14, 2015

First Submitted That Met QC Criteria

July 31, 2015

First Posted (Estimate)

August 3, 2015

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 20, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSEULS-PI-002/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Migraine

Clinical Trials on No intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe