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Completed

NCT Number: NCT02514148

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

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)

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Key information

Conditions

Chronic Migraine Brain Diseases Central Nervous System Diseases Chronic Headache Headache Disorders Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unidad de Ciencias Neurológicas

Madrid, 28003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapeutic patient education

Behavioral

Therapeutic patient education based on pain physiology from a biobehavioral perspective adding a training in coping strategies.

Other names: TPE

Therapeutic exercise

Other

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

No intervention

Other

No intervention consist on measure the whole variables in chronic migraine patients to compare it with experimental interventions

Other names: NI

Manual therapy

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Madrid

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Aug 3, 2015
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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