NCT02514148

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Universidad Autonoma de Madrid · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Migraine
• Chronic Headache

Interventions

Type	Name	Description
BEHAVIORAL	Therapeutic patient education	Therapeutic patient education based on pain physiology from a biobehavioral perspective adding a training in coping strategies.
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	No intervention	No intervention consist on measure the whole variables in chronic migraine patients to compare it with experimental interventions
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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-10-01
• Completion: 2019-10-01
• First posted: 2015-08-03
• Last updated: 2021-10-21

Locations

1 site across 1 country: Spain