Impementation of the Exercise Recommendations for the Treatment of Primary Headaches: A Qualitative Approach to the Headache Units in Catalonia (RECEPTA)

Implementació de Recomanacions d'Exercici Per al Tractament de Les Cefalees primàries: Una aproximació Qualitativa a Les Unitats de Cefalea a Catalunya

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Migraine; Headache; Chronic Headache
• Intervention / Treatment: Other: Interviews; Other: Surveys

Detailed Description

Therapeutic exercise strategies (TES) includes modalities such as aerobic activity and strength training, which have been investigated as treatments for primary headache in recent years. These modalities have been previously summarized, and despite the fact that the body of evidence available is less than in other therapeutic modalities, this is increasing, and they are positioned as strategies with a moderate effect size and recommendation.

However, its implementation is not simple and requires resources, such as professionals with specialized training, infrastructure, and clearly defined care circuits. Conversely, these strategies have demonstrated cost-effectiveness in other chronic pain conditions with similar treatment and care demands.

It is of interest to increase knowledge in this area given that the size of the effect of these interventions is large, although it varies according to the analyzed variable and type of exercise modality. The reduction in days per month with headache or migraine, reduction in headache hours per month, or decrease in headache intensity has been demonstrated in a non-negligible number of patients, but larger samples are needed.

The present study aimed to determine the status of exercise recommendations in the headache units of the Catalan territory and to evaluate the possible fit of specialized physiotherapy for the treatment of patients with headaches within these units based on the opinion of the responsible members of these units and available resources.

Contact with the headache units of the Catalan territory will be made by email or telephone during November 2023.

Semi-structured interviews and a survey developed from the interviews with the members of the units will be conducted to determine the status of exercise recommendations in the headache units of the Catalan territory and to evaluate the possible viability of specialized physiotherapy for the treatment of patients with headaches.

A total of 8-12 interviews and 20-30 responses to the surveys were expected. These will include neurologists, nurses, pharmacists, managers, rehabilitation doctors, and physiotherapists linked to neurology services.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Manresa, Barcelona, Spain, 08242
      • University of Manresa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

9

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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: Interviews; Semi-structured interviews; Other: Surveys; Estructured survey
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: Interviews; Semi-structured interviews; Other: Surveys; Estructured survey
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: Interviews; Semi-structured interviews; Other: Surveys; Estructured survey
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: Interviews; Semi-structured interviews; Other: Surveys; Estructured survey
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: Interviews; Semi-structured interviews; Other: Surveys; Estructured survey
Headache Unit of Hospital de Bellvitge - Barcelona; Neurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit.	Other: Interviews; Semi-structured interviews; Other: Surveys; Estructured survey
Headache Unit of Hospital del Mar - Barcelona; Neurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit.	Other: Interviews; Semi-structured interviews; Other: Surveys; Estructured survey
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: Interviews; Semi-structured interviews; Other: Surveys; Estructured survey
Headache Unit of Hospital Josep Trueta - Girona; Neurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit.	Other: Interviews; Semi-structured interviews; Other: Surveys; Estructured survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Create a survey for assessing headache unit resources.	List of essencial items to be included in the headache unit survey. Discussed by consensus among authors.	During November 2023
Necessary material resources	List of material resources needed for implementing physiotherapy in the headache units. Identified through semi-structured interviews.	During observation period from November 2023 to January 2024.
Necessary technological resources	List of technological resources needed for implementing physiotherapy in the headache units. Identified through semi-structured interviews.	During observation period from November 2023 to January 2024.
Necessary human resources	List of human resources needed for implementing physiotherapy in the headache units. Identified through semi-structured interviews.	During observation period from November 2023 to January 2024.
Necessary service resources	List of service resources needed for implementing physiotherapy in the headache units. Identified through semi-structured interviews.	During observation period from November 2023 to January 2024.
Necessary additional resources	List of additional resources needed for implementing physiotherapy in the headache units. Identified through semi-structured interviews.	During observation period from November 2023 to January 2024.
Acceptance to implementation therapeutic exercice strategies	Number of headache units that accepts to participate in a protocol to implement any of the therapeutic exercice strategies.	December 2023

Collaborators and Investigators

• Sponsor: Fundació Universitària del Bages

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 20, 2024
• Primary Completion (Estimated): May 20, 2024
• Study Completion (Estimated): June 20, 2024

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Physiotherapy; Exercise therapy; Neurology; Primary headaches; Headache units
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache; Headache Disorders
• Other Study ID Numbers: I-RECEPTA JPA003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Should be discussed with the participants

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No