Biobehavioral Physical Therapy Strategies Based on Therapeutic Exercise Applied to Chronic Migraine Patients
Keywords
Abstract
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.
Dates
| Last Verified: | 04/30/2016 |
| First Submitted: | 05/13/2015 |
| Estimated Enrollment Submitted: | 07/30/2015 |
| First Posted: | 08/02/2015 |
| Last Update Submitted: | 02/16/2017 |
| Last Update Posted: | 02/19/2017 |
| Actual Study Start Date: | 08/31/2015 |
| Estimated Primary Completion Date: | 09/30/2018 |
| Estimated Study Completion Date: | 09/30/2019 |
Condition or disease
Intervention/treatment
Behavioral: Therapeutic patient education
Other: Therapeutic exercise
Other: NO Intervention Control group
Other: TE + TPE + Manual therapy
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Other: 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 Control group No intervention consist on measure the whole variables in chronic migraine patients to compare it with experimental interventions |
| Experimental: Therapeutic exercise( TE) The intervention giving to the patients consist on a therapeutic exercise protocol based on neck and low intensity general exercises. | |
| Experimental: Therapeutic patient education ( TPE) The intervention giving to the patients consist on a therapeutic patient education based on pain neurophysiology protocol. | |
| Experimental: TE + TPE The intervention giving to the patients consist on the combination of the therapeutic exercise protocol and the therapeutic patient education protocol. | |
| 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. | Other: TE + TPE + 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| 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 |
Outcome
Primary Outcome Measures
1. Quality of Life measured by the HIT-6 Questionnaire [Baseline]
Secondary Outcome Measures
1. Cervical range of Motion measured by CROM ( cervical range of motion device) [Baseline , 6 weeks, 2 months, 4 months, 6 months, one year]
2. Temporal Summation measured by Von Frey filament [Baseline , 6 weeks, 2 months, 4 months, 6 months, one year]
3. Sleep Disorders measured by Latineen index score [Baseline , 6 weeks, 2 months, 4 months, 6 months, one year]
4. Medication Adherence scored by a medication calendar [Baseline , 6 weeks, 2 months, 4 months, 6 months, one year]
5. 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]
6. Anxiety measured by EUROQOL score [Baseline , 6 weeks, 2 months, 4 months, 6 months, one year]
7. Catastrophization measured by PCS ( Pain Catastrophizing Scale) [Baseline , 6 weeks, 2 months, 4 months, 6 months, one year]
8. Phobic Disorders measured by Chronic Pain self-efficacy Scale, BECK [Baseline , 6 weeks, 2 months, 4 months, 6 months, one year]
9. 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]
10. Self Efficacy measured by Chronic Pain self-efficacy Scale [Baseline , 6 weeks, 2 months, 4 months, 6 months, one year]
11. Pain perception outcome assessed by VAS [Baseline , 6 weeks, 2 months, 4 months, 6 months, one year]
12. Quality of Life measured by the HIT-6 Questionnaire [Baseline , 6 weeks, 2 months, 4 months, 6 months, one year]
13. Physical activity measured by IPAQ ( International physical Activity questionnaire) [Baseline , 6 weeks, 2 months, 4 months, 6 months, one year]
14. Pain Threshold measured by algometer [Baseline , 6 weeks, 2 months, 4 months, 6 months, one year]
15. Pain behaviour assessed by PBQ questionnaire ( Pain behaviour questionnaire) [Baseline , 6 weeks, 2 months, 4 months, 6 months, one year]
16. Kinesiophobia measured by TSK ( Tampa Scale of Kinesiophobia) [Baseline , 6 weeks, 2 months, 4 months, 6 months, one year]
