Chronic MigraineNCT02514148
Biobehavioral Physical Therapy Strategies Based on Therapeutic Exercise Applied to Chronic Migraine Patients
A study testing Therapeutic patient education, Therapeutic exercise and Manual Therapy in people with Chronic Migraine and Chronic Headache, run by Universidad Autonoma de Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Migraine, Chronic Headache
- What is being tested?
- Therapeutic patient education, Therapeutic exercise and Manual Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2015to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
Read the 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
- Being tested
- Therapeutic patient education, Therapeutic exercise, No intervention, Manual Therapy
- Keywords
- patient education, therapeutic exercise, manual therapy
- Medical subject headings
- Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic patient educationBehavioural
Also called TPE
Therapeutic patient education based on pain physiology from a biobehavioral perspective adding a training in coping strategies.
Therapeutic exerciseOther
Also called TE
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 interventionOther
Also called NI
No intervention consist on measure the whole variables in chronic migraine patients to compare it with experimental interventions
Manual TherapyOther
Also called MT
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.
| Study group | Role | What they receive |
|---|---|---|
| NO Intervention Control group | Other | No therapeutic intervention are being giving to the group of patients, they only will have their Neurologist previously prescribed pharmacological treatment. Receives: Other: No intervention |
| Therapeutic exercise( TE) | Experimental | The intervention giving to the patients consist on a therapeutic exercise protocol based on neck and low intensity general exercises. Receives: Other: Therapeutic exercise |
| Therapeutic patient education ( TPE) | Experimental | The intervention giving to the patients consist on a therapeutic patient education based on pain neurophysiology protocol. Receives: Behavioral: Therapeutic patient education |
| TE + TPE | Experimental | The intervention giving to the patients consist on the combination of the therapeutic exercise protocol and the therapeutic patient education protocol. Receives: Behavioral: Therapeutic patient education; Other: Therapeutic exercise |
| TE + TPE + Manual therapy | Experimental | 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. Receives: Behavioral: Therapeutic patient education; Other: Therapeutic exercise; Other: Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (16)
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.
Measured: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
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).)
Measured: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
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
Measured: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
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
Measured: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
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
Measured: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Anxiety measured by EUROQOL score
Feeling or emotion of dread, apprehension, and impending disaster but not disabling as with ANXIETY DISORDERS.
Measured: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
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.
Measured: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
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.
Measured: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
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.
Measured: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
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.
Measured: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Pain perception outcome assessed by VAS
The process by which PAIN is recognized and interpreted by the brain.
Measured: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
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.
Measured: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
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.
Measured: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Pain Threshold measured by algometer
Amount of stimulation required before the sensation of pain is experienced.
Measured: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Pain behaviour assessed by PBQ questionnaire ( Pain behaviour questionnaire)
The process by which PAIN is recognized and interpreted by the brain.
Measured: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Kinesiophobia measured by TSK ( Tampa Scale of Kinesiophobia)
Fear of having a painfull experience due to mevement
Measured: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2018
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Kindelan, Universidad Autonoma de Madrid
- Investigators
- Paula Kindelan, MSc, Principal investigator, associate professor Universidad Autónoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514148
- Sponsor's protocol ID
- CSEULS-PI-002/2013
- Status last verified
- Oct 2021
- First submitted
- 14 May 2015
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Latimer KM. Chronic headache: stop the pain before it starts. J Fam Pract. 2013 Mar;62(3):126-33.
PubMed 23520582Pozo-Rosich P. [Chronic migraine: its epidemiology and impact]. Rev Neurol. 2012 Apr 10;54 Suppl 2:S3-11. Spanish.
PubMed 22532240Bashir 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.
PubMed 23986301Volcy 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. doi: 10.1111/j.1526-4610.2005.05193_2.x.
PubMed 16109127Calhoun 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.
PubMed 20100298Headache 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. No abstract available.
PubMed 23771276Lipton 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. doi: 10.1212/01.wnl.0000252808.97649.21.
PubMed 17261680Ruscheweyh R, Muller 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.
PubMed 23980919Finocchi 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.
PubMed 20464594Bartsch T, Goadsby PJ. The trigeminocervical complex and migraine: current concepts and synthesis. Curr Pain Headache Rep. 2003 Oct;7(5):371-6. doi: 10.1007/s11916-003-0036-y.
PubMed 12946290Grazzi 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.
PubMed 21533706Gerber WD, Schoenen J. Biobehavioral correlates in migraine: the role of hypersensitivity and information-processing dysfunction. Cephalalgia. 1998 Feb;18 Suppl 21:5-11. doi: 10.1177/0333102498018s2103.
PubMed 9533662Stanos 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.
PubMed 22427179Andrasik F, Buse DC, Grazzi L. Behavioral medicine for migraine and medication overuse headache. Curr Pain Headache Rep. 2009 Jun;13(3):241-8. doi: 10.1007/s11916-009-0041-x.
PubMed 19457287Carlson 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.
PubMed 18343324
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Physical Therapy Strategies Based on Therapeutic Exercise Applied to Chronic Migraine Patients
- ClinicalTrials.gov ID
- NCT02514148
- Acronym / sponsor ID
- CSEULS-PI-002/2013
- Conditions
- Chronic Migraine, Chronic Headache
- Keywords
- patient education, therapeutic exercise, manual therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 3 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| NO Intervention Control group | Other | Other: No interventionNo therapeutic intervention are being giving to the group of patients, they only will have their Neurologist previously prescribed pharmacological treatment. |
| Therapeutic exercise( TE) | Experimental | Other: Therapeutic exerciseThe intervention giving to the patients consist on a therapeutic exercise protocol based on neck and low intensity general exercises. |
| Therapeutic patient education ( TPE) | Experimental | Behavioral: Therapeutic patient educationThe intervention giving to the patients consist on a therapeutic patient education based on pain neurophysiology protocol. |
| TE + TPE | Experimental | Behavioral: Therapeutic patient education, Other: Therapeutic exerciseThe intervention giving to the patients consist on the combination of the therapeutic exercise protocol and the therapeutic patient education protocol. |
| TE + TPE + Manual therapy | Experimental | Behavioral: Therapeutic patient education, Other: Therapeutic exercise, Other: Manual TherapyThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic patient educationAlso: TPETherapeutic patient education based on pain physiology from a biobehavioral perspective adding a training in coping strategies. | Behavioural | TE + TPE, TE + TPE + Manual therapy, Therapeutic patient education ( TPE) |
| Therapeutic exerciseAlso: TETherapeutic 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 | TE + TPE, TE + TPE + Manual therapy, Therapeutic exercise( TE) |
| No interventionAlso: NINo intervention consist on measure the whole variables in chronic migraine patients to compare it with experimental interventions | Other | NO Intervention Control group |
| Manual TherapyAlso: MTManual 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. | Other | TE + TPE + Manual therapy |
Primary outcome
Quality of Life measured by the HIT-6 Questionnaire
Time frame: 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.
16 secondary outcomes
Cervical range of Motion measured by CROM ( cervical range of motion device)
Time frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Temporal Summation measured by Von Frey filament
Time frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Sleep Disorders measured by Latineen index score
Time frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Medication Adherence scored by a medication calendar
Time frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Cope (Adaptation, Psychological) measured by CADC questionnaire ( Adaptation of the Chronic Pain self-efficacy Scale) and CAD- R questionnaire
Time frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Anxiety measured by EUROQOL score
Time frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Catastrophization measured by PCS ( Pain Catastrophizing Scale)
Time frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Phobic Disorders measured by Chronic Pain self-efficacy Scale, BECK
Time frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Disability Evaluation measured by neck disability Index and CF-PDI ( Craniofacial pain and disability inventory)
Time frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Self Efficacy measured by Chronic Pain self-efficacy Scale
Time frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Pain perception outcome assessed by VAS
Time frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Quality of Life measured by the HIT-6 Questionnaire
Time frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Physical activity measured by IPAQ ( International physical Activity questionnaire)
Time frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Pain Threshold measured by algometer
Time frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Pain behaviour assessed by PBQ questionnaire ( Pain behaviour questionnaire)
Time frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Kinesiophobia measured by TSK ( Tampa Scale of Kinesiophobia)
Time frame: Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Background: PubMed 23520582Latimer KM. Chronic headache: stop the pain before it starts. J Fam Pract. 2013 Mar;62(3):126-33.
- Background: PubMed 22532240Pozo-Rosich P. [Chronic migraine: its epidemiology and impact]. Rev Neurol. 2012 Apr 10;54 Suppl 2:S3-11. Spanish.
- Background: PubMed 23986301Bashir 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.
- Background: PubMed 16109127Volcy 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. doi: 10.1111/j.1526-4610.2005.05193_2.x.
- Background: PubMed 20100298Calhoun 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.
- Background: PubMed 23771276Headache 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. No abstract available.
- Background: PubMed 17261680Lipton 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. doi: 10.1212/01.wnl.0000252808.97649.21.
- Background: PubMed 23980919Ruscheweyh R, Muller 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.
- Background: PubMed 20464594Finocchi 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.
- Background: PubMed 12946290Bartsch T, Goadsby PJ. The trigeminocervical complex and migraine: current concepts and synthesis. Curr Pain Headache Rep. 2003 Oct;7(5):371-6. doi: 10.1007/s11916-003-0036-y.
- Background: PubMed 21533706Grazzi 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.
- Background: PubMed 9533662Gerber WD, Schoenen J. Biobehavioral correlates in migraine: the role of hypersensitivity and information-processing dysfunction. Cephalalgia. 1998 Feb;18 Suppl 21:5-11. doi: 10.1177/0333102498018s2103.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Kindelan, MSc principal investigator
associate professor Universidad Autónoma de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic patient education, Therapeutic exercise and Manual Therapy in people with Chronic Migraine and Chronic Headache, run by Universidad Autonoma de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life measured by the HIT-6 Questionnaire (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02514148, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.