Clinical trial NCT02514148: Biobehavioral Physical Therapy Strategies Based on Therapeutic Exercise Applied to Chronic Migraine Patients
Official title: Biobehavioral Physical Therapy Strategies Based on Therapeutic Exercise Applied to Chronic Migraine Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Migraine
Chronic Headache
Keywords: patient education
therapeutic exercise
manual therapy
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
First posted: 2015-08-03
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Quality of Life measured by the HIT-6 Questionnaire
timeFrame: Baseline
Secondary outcomes:
measure: Cervical range of Motion measured by CROM ( cervical range of motion device)
timeFrame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
measure: Temporal Summation measured by Von Frey filament
timeFrame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
measure: Sleep Disorders measured by Latineen index score
timeFrame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
measure: Medication Adherence scored by a medication calendar
timeFrame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
measure: Cope (Adaptation, Psychological) measured by CADC questionnaire ( Adaptation of the Chronic Pain self-efficacy Scale) and CAD- R questionnaire
timeFrame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
measure: Anxiety measured by EUROQOL score
timeFrame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
measure: Catastrophization measured by PCS ( Pain Catastrophizing Scale)
timeFrame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
measure: Phobic Disorders measured by Chronic Pain self-efficacy Scale, BECK
timeFrame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
measure: Disability Evaluation measured by neck disability Index and CF-PDI ( Craniofacial pain and disability inventory)
timeFrame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
measure: Self Efficacy measured by Chronic Pain self-efficacy Scale
timeFrame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
measure: Pain perception outcome assessed by VAS
timeFrame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
measure: Quality of Life measured by the HIT-6 Questionnaire
timeFrame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
measure: Physical activity measured by IPAQ ( International physical Activity questionnaire)
timeFrame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
measure: Pain Threshold measured by algometer
timeFrame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
measure: Pain behaviour assessed by PBQ questionnaire ( Pain behaviour questionnaire)
timeFrame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
measure: Kinesiophobia measured by TSK ( Tampa Scale of Kinesiophobia)
timeFrame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Unidad de Ciencias Neurológicas
Study officials:
affiliation: associate professor Universidad Autónoma de Madrid
name: Paula Kindelan, MSc
role: PRINCIPAL_INVESTIGATOR
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