Chronic Headache, Chronic Migraine
Conditions
Keywords
patient education, therapeutic exercise, manual therapy
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)
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.
Interventions
BEHAVIORALTherapeutic patient education
Therapeutic patient education based on pain physiology from a biobehavioral perspective adding a training in coping strategies.
OTHERTherapeutic 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.
OTHERNo intervention
No intervention consist on measure the whole variables in chronic migraine patients to compare it with experimental interventions
OTHERManual 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.
Sponsors
Universidad Autonoma de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life measured by the HIT-6 Questionnaire | 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
| Measure | Time frame | Description |
|---|---|---|
| Temporal Summation measured by Von Frey filament | 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).) |
| Sleep Disorders measured by Latineen index score | 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 |
| Medication Adherence scored by a medication calendar | 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 |
| Cope (Adaptation, Psychological) measured by CADC questionnaire ( Adaptation of the Chronic Pain self-efficacy Scale) and CAD- R questionnaire | 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 |
| Anxiety measured by EUROQOL score | 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. |
| Catastrophization measured by PCS ( Pain Catastrophizing Scale) | 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. |
| Phobic Disorders measured by Chronic Pain self-efficacy Scale, BECK | 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. |
| Cervical range of Motion measured by CROM ( cervical range of motion device) | 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. |
| Self Efficacy measured by Chronic Pain self-efficacy Scale | 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. |
| Pain perception outcome assessed by VAS | Baseline , 6 weeks, 2 months, 4 months, 6 months, one year | The process by which PAIN is recognized and interpreted by the brain. |
| Quality of Life measured by the HIT-6 Questionnaire | 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. |
| Physical activity measured by IPAQ ( International physical Activity questionnaire) | 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. |
| Pain Threshold measured by algometer | Baseline , 6 weeks, 2 months, 4 months, 6 months, one year | Amount of stimulation required before the sensation of pain is experienced. |
| Pain behaviour assessed by PBQ questionnaire ( Pain behaviour questionnaire) | Baseline , 6 weeks, 2 months, 4 months, 6 months, one year | The process by which PAIN is recognized and interpreted by the brain. |
| Kinesiophobia measured by TSK ( Tampa Scale of Kinesiophobia) | Baseline , 6 weeks, 2 months, 4 months, 6 months, one year | Fear of having a painfull experience due to mevement |
| Disability Evaluation measured by neck disability Index and CF-PDI ( Craniofacial pain and disability inventory) | 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. |
Countries
Spain
Outcome results
None listed