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

Chronic Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514148
• Other study ID #: CSEULS-PI-002/2013
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: October 2019

Study information

• Verified date: October 2021
• Source: Universidad Autonoma de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Headache
• Chronic Migraine
• Headache
• Headache Disorders
• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
Spain	Unidad de Ciencias Neurológicas	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (21)

Andrasik F, Buse DC, Grazzi L. Behavioral medicine for migraine and medication overuse headache. Curr Pain Headache Rep. 2009 Jun;13(3):241-8. Review. — View Citation

Bartsch T, Goadsby PJ. The trigeminocervical complex and migraine: current concepts and synthesis. Curr Pain Headache Rep. 2003 Oct;7(5):371-6. Review. — View Citation

Bashir A, Lipton RB, Ashina S, Ashina M. Migraine and structural changes in the brain: a systematic review and meta-analysis. Neurology. 2013 Oct 1;81(14):1260-8. doi: 10.1212/WNL.0b013e3182a6cb32. Epub 2013 Aug 28. Review. — View Citation

Buse DC, Andrasik F. Behavioral medicine for migraine. Neurol Clin. 2009 May;27(2):445-65. doi: 10.1016/j.ncl.2009.01.003. Review. — View Citation

Calhoun AH, Ford S, Millen C, Finkel AG, Truong Y, Nie Y. The prevalence of neck pain in migraine. Headache. 2010 Sep;50(8):1273-7. doi: 10.1111/j.1526-4610.2009.01608.x. Epub 2010 Jan 18. — View Citation

Carlson CR. Psychological considerations for chronic orofacial pain. Oral Maxillofac Surg Clin North Am. 2008 May;20(2):185-95, vi. doi: 10.1016/j.coms.2007.12.002. Review. — View Citation

Daviet JC, Bonan I, Caire JM, Colle F, Damamme L, Froger J, Leblond C, Leger A, Muller F, Simon O, Thiebaut M, Yelnik A. Therapeutic patient education for stroke survivors: Non-pharmacological management. A literature review. Ann Phys Rehabil Med. 2012 Dec;55(9-10):641-56. doi: 10.1016/j.rehab.2012.08.011. Epub 2012 Sep 7. Review. English, French. — View Citation

Finocchi C, Villani V, Casucci G. Therapeutic strategies in migraine patients with mood and anxiety disorders: clinical evidence. Neurol Sci. 2010 Jun;31 Suppl 1:S95-8. doi: 10.1007/s10072-010-0297-2. Review. — View Citation

Gerber WD, Schoenen J. Biobehavioral correlates in migraine: the role of hypersensitivity and information-processing dysfunction. Cephalalgia. 1998 Feb;18 Suppl 21:5-11. Review. — View Citation

Grazzi L, Bussone G. What future for treatment of chronic migraine with medication overuse? Neurol Sci. 2011 May;32 Suppl 1:S19-22. doi: 10.1007/s10072-011-0553-0. Review. — View Citation

Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. — View Citation

Kindelan-Calvo P, Gil-Martínez A, Paris-Alemany A, Pardo-Montero J, Muñoz-García D, Angulo-Díaz-Parreño S, La Touche R. Effectiveness of therapeutic patient education for adults with migraine. A systematic review and meta-analysis of randomized controlled trials. Pain Med. 2014 Sep;15(9):1619-36. doi: 10.1111/pme.12505. Epub 2014 Aug 26. Review. — View Citation

Latimer KM. Chronic headache: stop the pain before it starts. J Fam Pract. 2013 Mar;62(3):126-33. Review. — View Citation

Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF; AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007 Jan 30;68(5):343-9. — View Citation

Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198. Review. — View Citation

Nicholson R, Nash J, Andrasik F. A self-administered behavioral intervention using tailored messages for migraine. Headache. 2005 Oct;45(9):1124-39. — View Citation

Pozo-Rosich P. [Chronic migraine: its epidemiology and impact]. Rev Neurol. 2012 Apr 10;54 Suppl 2:S3-11. Review. Spanish. — View Citation

Rains JC, Penzien DB, McCrory DC, Gray RN. Behavioral headache treatment: history, review of the empirical literature, and methodological critique. Headache. 2005 May;45 Suppl 2:S92-109. Review. — View Citation

Ruscheweyh R, Müller M, Blum B, Straube A. Correlation of headache frequency and psychosocial impairment in migraine: a cross-sectional study. Headache. 2014 May;54(5):861-71. doi: 10.1111/head.12195. Epub 2013 Aug 23. — View Citation

Stanos S. Focused review of interdisciplinary pain rehabilitation programs for chronic pain management. Curr Pain Headache Rep. 2012 Apr;16(2):147-52. doi: 10.1007/s11916-012-0252-4. Review. — View Citation

Volcy M, Sheftell FD, Tepper SJ, Rapoport AM, Bigal ME. Tinnitus in migraine: an allodynic symptom secondary to abnormal cortical functioning? Headache. 2005 Sep;45(8):1083-7. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life measured by the HIT-6 Questionnaire	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.	Baseline
Secondary	Cervical range of Motion measured by CROM ( cervical range of motion device)	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.	Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Secondary	Temporal Summation measured by Von Frey filament	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).)	Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Secondary	Sleep Disorders measured by Latineen index score	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	Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Secondary	Medication Adherence scored by a medication calendar	Voluntary cooperation of the patient in taking drugs or medicine as prescribed. This includes timing, dosage, and frequency	Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Secondary	Cope (Adaptation, Psychological) measured by CADC questionnaire ( Adaptation of the Chronic Pain self-efficacy Scale) and CAD- R questionnaire	A state of harmony between internal needs and external demands and the processes used in achieving this condition	Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Secondary	Anxiety measured by EUROQOL score	Feeling or emotion of dread, apprehension, and impending disaster but not disabling as with ANXIETY DISORDERS.	Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Secondary	Catastrophization measured by PCS ( Pain Catastrophizing Scale)	Cognitive and emotional processes encompassing magnification of pain-related stimuli, feelings of helplessness, and a generally pessimistic orientation.	Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Secondary	Phobic Disorders measured by Chronic Pain self-efficacy Scale, BECK	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.	Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Secondary	Disability Evaluation measured by neck disability Index and CF-PDI ( Craniofacial pain and disability inventory)	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.	Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Secondary	Self Efficacy measured by Chronic Pain self-efficacy Scale	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.	Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Secondary	Pain perception outcome assessed by VAS	The process by which PAIN is recognized and interpreted by the brain.	Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Secondary	Quality of Life measured by the HIT-6 Questionnaire	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.	Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Secondary	Physical activity measured by IPAQ ( International physical Activity questionnaire)	The performance of the basic activities of self care or sport such as dressing, ambulation, eating, walking or practicing sports.	Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Secondary	Pain Threshold measured by algometer	Amount of stimulation required before the sensation of pain is experienced.	Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Secondary	Pain behaviour assessed by PBQ questionnaire ( Pain behaviour questionnaire)	The process by which PAIN is recognized and interpreted by the brain.	Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Secondary	Kinesiophobia measured by TSK ( Tampa Scale of Kinesiophobia)	Fear of having a painfull experience due to mevement	Baseline , 6 weeks, 2 months, 4 months, 6 months, one year