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

Primary Purpose

Chronic Migraine, Chronic Headache

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Therapeutic patient education
Therapeutic exercise
No intervention
Manual Therapy
Sponsored by
Universidad Autonoma de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Migraine focused on measuring patient education, therapeutic exercise, manual therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Unidad de Ciencias Neurológicas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Experimental

Experimental

Experimental

Experimental

Arm Label

NO Intervention Control group

Therapeutic exercise( TE)

Therapeutic patient education ( TPE)

TE + TPE

TE + TPE + Manual therapy

Arm Description

No therapeutic intervention are being giving to the group of patients, they only will have their Neurologist previously prescribed pharmacological treatment.

The intervention giving to the patients consist on a therapeutic exercise protocol based on neck and low intensity general exercises.

The intervention giving to the patients consist on a therapeutic patient education based on pain neurophysiology protocol.

The intervention giving to the patients consist on the combination of the therapeutic exercise protocol and the therapeutic patient education protocol.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).)
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
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
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
Anxiety measured by EUROQOL score
Feeling or emotion of dread, apprehension, and impending disaster but not disabling as with ANXIETY DISORDERS.
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.
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.
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.
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.
Pain perception outcome assessed by VAS
The process by which PAIN is recognized and interpreted by the brain.
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.
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.
Pain Threshold measured by algometer
Amount of stimulation required before the sensation of pain is experienced.
Pain behaviour assessed by PBQ questionnaire ( Pain behaviour questionnaire)
The process by which PAIN is recognized and interpreted by the brain.
Kinesiophobia measured by TSK ( Tampa Scale of Kinesiophobia)
Fear of having a painfull experience due to mevement

Full Information

First Posted
May 14, 2015
Last Updated
October 20, 2021
Sponsor
Universidad Autonoma de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT02514148
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Madrid

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine, Chronic Headache
Keywords
patient education, therapeutic exercise, manual therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NO Intervention Control group
Arm Type
Other
Arm Description
No therapeutic intervention are being giving to the group of patients, they only will have their Neurologist previously prescribed pharmacological treatment.
Arm Title
Therapeutic exercise( TE)
Arm Type
Experimental
Arm Description
The intervention giving to the patients consist on a therapeutic exercise protocol based on neck and low intensity general exercises.
Arm Title
Therapeutic patient education ( TPE)
Arm Type
Experimental
Arm Description
The intervention giving to the patients consist on a therapeutic patient education based on pain neurophysiology protocol.
Arm Title
TE + TPE
Arm Type
Experimental
Arm Description
The intervention giving to the patients consist on the combination of the therapeutic exercise protocol and the therapeutic patient education protocol.
Arm Title
TE + TPE + Manual therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic patient education
Other Intervention Name(s)
TPE
Intervention Description
Therapeutic patient education based on pain physiology from a biobehavioral perspective adding a training in coping strategies.
Intervention Type
Other
Intervention Name(s)
Therapeutic exercise
Other Intervention Name(s)
TE
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No intervention
Other Intervention Name(s)
NI
Intervention Description
No intervention consist on measure the whole variables in chronic migraine patients to compare it with experimental interventions
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Other Intervention Name(s)
MT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Life measured by the HIT-6 Questionnaire
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Cervical range of Motion measured by CROM ( cervical range of motion device)
Description
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.
Time Frame
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Title
Temporal Summation measured by Von Frey filament
Description
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).)
Time Frame
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Title
Sleep Disorders measured by Latineen index score
Description
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
Time Frame
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Title
Medication Adherence scored by a medication calendar
Description
Voluntary cooperation of the patient in taking drugs or medicine as prescribed. This includes timing, dosage, and frequency
Time Frame
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Title
Cope (Adaptation, Psychological) measured by CADC questionnaire ( Adaptation of the Chronic Pain self-efficacy Scale) and CAD- R questionnaire
Description
A state of harmony between internal needs and external demands and the processes used in achieving this condition
Time Frame
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Title
Anxiety measured by EUROQOL score
Description
Feeling or emotion of dread, apprehension, and impending disaster but not disabling as with ANXIETY DISORDERS.
Time Frame
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Title
Catastrophization measured by PCS ( Pain Catastrophizing Scale)
Description
Cognitive and emotional processes encompassing magnification of pain-related stimuli, feelings of helplessness, and a generally pessimistic orientation.
Time Frame
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Title
Phobic Disorders measured by Chronic Pain self-efficacy Scale, BECK
Description
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.
Time Frame
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Title
Disability Evaluation measured by neck disability Index and CF-PDI ( Craniofacial pain and disability inventory)
Description
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.
Time Frame
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Title
Self Efficacy measured by Chronic Pain self-efficacy Scale
Description
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.
Time Frame
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Title
Pain perception outcome assessed by VAS
Description
The process by which PAIN is recognized and interpreted by the brain.
Time Frame
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Title
Quality of Life measured by the HIT-6 Questionnaire
Description
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.
Time Frame
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Title
Physical activity measured by IPAQ ( International physical Activity questionnaire)
Description
The performance of the basic activities of self care or sport such as dressing, ambulation, eating, walking or practicing sports.
Time Frame
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Title
Pain Threshold measured by algometer
Description
Amount of stimulation required before the sensation of pain is experienced.
Time Frame
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Title
Pain behaviour assessed by PBQ questionnaire ( Pain behaviour questionnaire)
Description
The process by which PAIN is recognized and interpreted by the brain.
Time Frame
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year
Title
Kinesiophobia measured by TSK ( Tampa Scale of Kinesiophobia)
Description
Fear of having a painfull experience due to mevement
Time Frame
Baseline , 6 weeks, 2 months, 4 months, 6 months, one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Kindelan, MSc
Organizational Affiliation
associate professor Universidad Autónoma de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unidad de Ciencias Neurológicas
City
Madrid
ZIP/Postal Code
28003
Country
Spain

12. IPD Sharing Statement

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

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