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

Migraine Clinical Trial

— RECEPTA  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06127888
• Other study ID #: I-RECEPTA JPA003
• Status: Enrolling by invitation
• Start date: March 20, 2024
• Est. completion date: June 20, 2024

Study information

• Verified date: November 2023
• Source: Fundació Universitària del Bages
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: June 20, 2024
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Headache
• Headache
• Headache Disorders
• Migraine

Intervention

Other:
• Interviews
Semi-structured interviews
• Surveys
Estructured survey

Locations

Country	Name	City	State
Spain	University of Manresa	Manresa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Universitària del Bages

Country where clinical trial is conducted

Spain, 

References & Publications (12)

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 clin — View Citation

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. Spa — View Citation

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 Ma — View Citation

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 randomiz — View Citation

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. — View Citation

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): — View Citation

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: 10.1 — View Citation

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. — View Citation

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: 10.11 — View Citation

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, Consi — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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