NCT06127888

Brief Summary

Therapeutic exercise, including aerobic activity and strength training, has shown promise in treating primary headaches with a moderate effect size, despite limited evidence. Implementation requires specialized professionals, infrastructure, and defined care pathways. These strategies are cost-effective for similar chronic pain conditions. More research is needed to better understand the varying effects on headache frequency, duration, and intensity in larger patient samples.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

February 12, 2024

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

November 8, 2023

Last Update Submit

February 9, 2024

Conditions

Keywords

Exercise therapyNeurologyHeadache unitsPrimary headachesPhysiotherapy

Outcome Measures

Primary Outcomes (3)

  • Status of exercise prescription in primary headaches

    Likert Scale from 1-5: (1) Not recommended, (2) occasionally recommended, (3) usually recommended, (4) occasionally recommended and supervised by a qualified professional, (5) usually recommended and supervised by a qualified professional. Through survey and interviews.

    During observation period from November 2023 to January 2024.

  • Viability of the exercise prescription in the headache units

    List of necessary resources for implementing exercise for primary headache patients reported by headache units. Qualitative information from surveys and interviews.

    During observation period from November 2023 to January 2024.

  • Relevance of exercise as a strategy for the treatment of patients with primary headaches.

    Likert 1-5: (1) Not interesting for headache management, (2) Low interest for headache management (3) Moderate interest for headache management (4) High interest for headache management (5) Absolute interest for headache management. Through survey and interviews.

    During observation period from November 2023 to January 2024.

Secondary Outcomes (7)

  • Create a survey for assessing headache unit resources.

    During November 2023

  • Necessary material resources

    During observation period from November 2023 to January 2024.

  • Necessary technological resources

    During observation period from November 2023 to January 2024.

  • Necessary human resources

    During observation period from November 2023 to January 2024.

  • Necessary service resources

    During observation period from November 2023 to January 2024.

  • +2 more secondary outcomes

Study Arms (9)

Unit of headache and neurological pain of the Hospital Vall d'Hebron (VHIR) - Barcelona

Neurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit.

Other: InterviewsOther: Surveys

Unit of headaches and neuralgias of the Hospital de Sant Pau - Barcelona

Neurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit.

Other: InterviewsOther: Surveys

Unit of headache of the Hospital Sant Joan de Déu - Althaia - Manresa

Neurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit.

Other: InterviewsOther: Surveys

Unit of headache of the Hospital Universitari Arnau de Vilanova - Lleida

Neurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit.

Other: InterviewsOther: Surveys

Group of work on headaches of the Hospital Clínic de Barcelona

Neurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit.

Other: InterviewsOther: Surveys

Headache Unit of Hospital de Bellvitge - Barcelona

Neurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit.

Other: InterviewsOther: Surveys

Headache Unit of Hospital del Mar - Barcelona

Neurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit.

Other: InterviewsOther: Surveys

Headache Unit of Hospital de Germans Tries i Pujol - Can Ruti - Badalona

Neurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit.

Other: InterviewsOther: Surveys

Headache Unit of Hospital Josep Trueta - Girona

Neurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit.

Other: InterviewsOther: Surveys

Interventions

Semi-structured interviews

Group of work on headaches of the Hospital Clínic de BarcelonaHeadache Unit of Hospital Josep Trueta - GironaHeadache Unit of Hospital de Bellvitge - BarcelonaHeadache Unit of Hospital de Germans Tries i Pujol - Can Ruti - BadalonaHeadache Unit of Hospital del Mar - BarcelonaUnit of headache and neurological pain of the Hospital Vall d'Hebron (VHIR) - BarcelonaUnit of headache of the Hospital Sant Joan de Déu - Althaia - ManresaUnit of headache of the Hospital Universitari Arnau de Vilanova - LleidaUnit of headaches and neuralgias of the Hospital de Sant Pau - Barcelona
SurveysOTHER

Estructured survey

Group of work on headaches of the Hospital Clínic de BarcelonaHeadache Unit of Hospital Josep Trueta - GironaHeadache Unit of Hospital de Bellvitge - BarcelonaHeadache Unit of Hospital de Germans Tries i Pujol - Can Ruti - BadalonaHeadache Unit of Hospital del Mar - BarcelonaUnit of headache and neurological pain of the Hospital Vall d'Hebron (VHIR) - BarcelonaUnit of headache of the Hospital Sant Joan de Déu - Althaia - ManresaUnit of headache of the Hospital Universitari Arnau de Vilanova - LleidaUnit of headaches and neuralgias of the Hospital de Sant Pau - Barcelona

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Neurologists, nurses, pharmacists, researchers, physical therapists, rehabilitation doctors, health manager of the headache unit or rehabilitation service connected to the headache unit.

You may qualify if:

  • Be part of the headache unit
  • Be a part of a service related to the headache unit
  • Be a healthcare practitioner, researcher, health manager or rehabilitation service manager.

You may not qualify if:

  • Decline participation
  • Unable to understand Catalan, Spanish or English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manresa

Manresa, Barcelona, 08242, Spain

Location

Related Publications (12)

  • Hanssen H, Minghetti A, Magon S, Rossmeissl A, Rasenack M, Papadopoulou A, Klenk C, Faude O, Zahner L, Sprenger T, Donath L. Effects of different endurance exercise modalities on migraine days and cerebrovascular health in episodic migraineurs: A randomized controlled trial. Scand J Med Sci Sports. 2018 Mar;28(3):1103-1112. doi: 10.1111/sms.13023. Epub 2018 Jan 8.

  • Kroll LS, Hammarlund CS, Linde M, Gard G, Jensen RH. The effects of aerobic exercise for persons with migraine and co-existing tension-type headache and neck pain. A randomized, controlled, clinical trial. Cephalalgia. 2018 Oct;38(12):1805-1816. doi: 10.1177/0333102417752119. Epub 2018 Jan 15.

  • Madsen BK, Sogaard K, Andersen LL, Tornoe B, Jensen RH. Efficacy of strength training on tension-type headache: A randomised controlled study. Cephalalgia. 2018 May;38(6):1071-1080. doi: 10.1177/0333102417722521. Epub 2017 Jul 27.

  • van Ettekoven H, Lucas C. Efficacy of physiotherapy including a craniocervical training programme for tension-type headache; a randomized clinical trial. Cephalalgia. 2006 Aug;26(8):983-91. doi: 10.1111/j.1468-2982.2006.01163.x.

  • Alvarez-Melcon AC, Valero-Alcaide R, Atin-Arratibel MA, Melcon-Alvarez A, Beneit-Montesinos JV. Effects of physical therapy and relaxation techniques on the parameters of pain in university students with tension-type headache: A randomised controlled clinical trial. Neurologia (Engl Ed). 2018 May;33(4):233-243. doi: 10.1016/j.nrl.2016.06.008. Epub 2016 Aug 1. English, Spanish.

  • Reina-Varona A, Madronero-Miguel B, Gaul C, Hall T, Oliveira AB, Bond DS, Fernandez-de Las Penas C, Florencio LL, Carvalho GF, Luedtke K, Varkey E, Kroll LS, Bevilaqua-Grossi D, Kisan R, La Touche R, Paris-Alemany A. Therapeutic Exercise Parameters, Considerations, and Recommendations for Migraine Treatment: An International Delphi Study. Phys Ther. 2023 Oct 3;103(10):pzad080. doi: 10.1093/ptj/pzad080.

  • Miyamoto GC, Lin CC, Cabral CMN, van Dongen JM, van Tulder MW. Cost-effectiveness of exercise therapy in the treatment of non-specific neck pain and low back pain: a systematic review with meta-analysis. Br J Sports Med. 2019 Feb;53(3):172-181. doi: 10.1136/bjsports-2017-098765. Epub 2018 Apr 20.

  • Del Llano Senaris JE, Correia NN, Logusso LG, Errea Rodriguez M, Bringas Roldan C. [The indirect costs of tension type headache. A systematic literature review]. Aten Primaria. 2022 Mar;54(3):102238. doi: 10.1016/j.aprim.2021.102238. Epub 2022 Jan 22. Spanish.

  • Salazar A, Berrocal L, Failde I. Prevalence of Migraine in General Spanish Population; Factors Related and Use of Health Resources. Int J Environ Res Public Health. 2021 Oct 23;18(21):11145. doi: 10.3390/ijerph182111145.

  • Jimenez-Trujillo I, Lopez-de-Andres A, Del Barrio JL, Hernandez-Barrera V, Valero-de-Bernabe M, Jimenez-Garcia R. Gender Differences in the Prevalence and Characteristics of Pain in Spain: Report from a Population-Based Study. Pain Med. 2019 Dec 1;20(12):2349-2359. doi: 10.1093/pm/pnz004.

  • Fierro A, Perez-Roji G, Blanco A, Lopez P, Andres M, Gonzalez-Quintanilla V, Perez-Pereda S, Fontanillas N, Pascual J. Headache as main reason for consultation to a hospital Emergency Department in Spain: a prospective study. Neurologia (Engl Ed). 2021 May 31:S0213-4853(21)00089-X. doi: 10.1016/j.nrl.2021.03.015. Online ahead of print. English, Spanish.

  • Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.

MeSH Terms

Conditions

Migraine DisordersHeadacheHeadache Disorders

Interventions

Interviews as TopicSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 13, 2023

Study Start

March 20, 2024

Primary Completion

May 20, 2024

Study Completion

June 20, 2024

Last Updated

February 12, 2024

Record last verified: 2023-11

Locations