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

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ClinicalTrials.gov Identifier: NCT02514148
Recruitment Status : Recruiting
First Posted : August 3, 2015
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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)

Condition or disease Intervention/treatment
Chronic Migraine Chronic Headache Behavioral: Therapeutic patient education Other: Therapeutic exercise Other: No intervention Other: Manual Therapy

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Biobehavioral Physical Therapy Strategies Based on Therapeutic Exercise Applied to Chronic Migraine Patients
Study Start Date : September 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 Name: 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 Name: 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 Name: 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.
Behavioral: Therapeutic patient education
Therapeutic patient education based on pain physiology from a biobehavioral perspective adding a training in coping strategies.
Other Name: TPE
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 Name: TE
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.
Behavioral: Therapeutic patient education
Therapeutic patient education based on pain physiology from a biobehavioral perspective adding a training in coping strategies.
Other Name: TPE
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 Name: TE
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 Name: MT


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).)

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.


  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514148


Contacts
Contact: Paula Kindelan, MSc +34661348103 paulakindelan@gmail.com

Locations
Spain
Unidad de Ciencias Neurológicas Recruiting
Madrid, Spain, 28003
Contact: paula Kindelan, MsC    661348103    paulakindelan@gmail.com   
Sub-Investigator: Beatriz Gómez Ramiro, MsC         
Sponsors and Collaborators
Universidad Autonoma de Madrid
Investigators
Principal Investigator: Paula Kindelan, MSc associate professor Universidad Autónoma de Madrid
More Information

Publications:

Responsible Party: Paula Kindelan, Associate Professor, Universidad autónoma de Madrid, Universidad Autonoma de Madrid
ClinicalTrials.gov Identifier: NCT02514148     History of Changes
Other Study ID Numbers: CSEULS-PI-002/2013
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: May 2016

Keywords provided by Paula Kindelan, Universidad Autonoma de Madrid:
patient education
therapeutic exercise
manual therapy

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders
Headache Disorders, Primary
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms