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

NCT02514148 | Completed DMC

• 1 other identifier: CSEULS-PI-002/2013
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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)

Conditions

Chronic Migraine; Chronic Headache

Keywords

patient education; therapeutic exercise; manual therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Cervical range of Motion measured by CROM ( cervical range of motion device)

  Baseline , 6 weeks, 2 months, 4 months, 6 months, one year

• Temporal Summation measured by Von Frey filament

  Baseline , 6 weeks, 2 months, 4 months, 6 months, one year

• Sleep Disorders measured by Latineen index score

  Baseline , 6 weeks, 2 months, 4 months, 6 months, one year

• Medication Adherence scored by a medication calendar

  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

  Baseline , 6 weeks, 2 months, 4 months, 6 months, one year

Study Arms (5)

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.

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.

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.

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.

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.

Behavioral: Therapeutic patient education; Other: Therapeutic exercise; Other: Manual Therapy

Interventions

Therapeutic patient education BEHAVIORAL

Therapeutic patient education based on pain physiology from a biobehavioral perspective adding a training in coping strategies.

Also known as: TPE

TE + TPE; TE + TPE + Manual therapy; Therapeutic patient education ( TPE)

Therapeutic exercise OTHER

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.

Also known as: TE

TE + TPE; TE + TPE + Manual therapy; Therapeutic exercise( TE)

No intervention OTHER

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

Also known as: NI

NO Intervention Control group

Manual Therapy OTHER

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.

Also known as: MT

TE + TPE + Manual therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Autonoma de Madrid: lead

Study Sites (1)

Unidad de Ciencias Neurológicas

Madrid, 28003, Spain

Location

Related Publications (21)

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  PMID: 23520582 BACKGROUND

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  PMID: 16109127 BACKGROUND

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  PMID: 20100298 BACKGROUND

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  PMID: 23771276 BACKGROUND

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  PMID: 17261680 BACKGROUND

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  PMID: 23980919 BACKGROUND

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  PMID: 12946290 BACKGROUND

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  PMID: 21533706 BACKGROUND

• Gerber 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.

  PMID: 9533662 BACKGROUND

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  PMID: 22427179 BACKGROUND

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  PMID: 19457287 BACKGROUND

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  PMID: 18343324 BACKGROUND

• 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. doi: 10.1111/j.1526-4610.2005.4502003.x.

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• 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. English, French.

  PMID: 23000090 BACKGROUND

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• Nicholson R, Nash J, Andrasik F. A self-administered behavioral intervention using tailored messages for migraine. Headache. 2005 Oct;45(9):1124-39. doi: 10.1111/j.1526-4610.2005.00236.x.

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

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• Kindelan-Calvo P, Gil-Martinez A, Paris-Alemany A, Pardo-Montero J, Munoz-Garcia D, Angulo-Diaz-Parreno 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.

  PMID: 25159212 BACKGROUND

MeSH Terms

Conditions

Headache Disorders

Interventions

Exercise Therapy; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Complementary Therapies

Study Officials

• Paula Kindelan, MSc

  associate professor Universidad Autónoma de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Universidad autónoma de Madrid

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: August 3, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2019
• Last Updated: October 21, 2021

Record last verified: 2021-10

Locations

ES (1)