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

Sponsor
Fundació Universitària del Bages (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06127888
Collaborator
(none)
30
1
2.3
12.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
30 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Implementació de Recomanacions d'Exercici Per al Tractament de Les Cefalees primàries: Una aproximació Qualitativa a Les Unitats de Cefalea a Catalunya
Anticipated Study Start Date :
Nov 5, 2023
Anticipated Primary Completion Date :
Dec 15, 2023
Anticipated Study Completion Date :
Jan 15, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Status of exercise prescription in primary headaches [During observation period from November 2023 to January 2024.]

    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.

  2. Viability of the exercise prescription in the headache units [During observation period from November 2023 to January 2024.]

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

  3. Relevance of exercise as a strategy for the treatment of patients with primary headaches. [During observation period from November 2023 to January 2024.]

    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.

Secondary Outcome Measures

  1. Create a survey for assessing headache unit resources. [During November 2023]

    List of essencial items to be included in the headache unit survey. Discussed by consensus among authors.

  2. Necessary material resources [During observation period from November 2023 to January 2024.]

    List of material resources needed for implementing physiotherapy in the headache units. Identified through semi-structured interviews.

  3. Necessary technological resources [During observation period from November 2023 to January 2024.]

    List of technological resources needed for implementing physiotherapy in the headache units. Identified through semi-structured interviews.

  4. Necessary human resources [During observation period from November 2023 to January 2024.]

    List of human resources needed for implementing physiotherapy in the headache units. Identified through semi-structured interviews.

  5. Necessary service resources [During observation period from November 2023 to January 2024.]

    List of service resources needed for implementing physiotherapy in the headache units. Identified through semi-structured interviews.

  6. Necessary additional resources [During observation period from November 2023 to January 2024.]

    List of additional resources needed for implementing physiotherapy in the headache units. Identified through semi-structured interviews.

  7. Acceptance to implementation therapeutic exercice strategies [December 2023]

    Number of headache units that accepts to participate in a protocol to implement any of the therapeutic exercice strategies.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Manresa Manresa Barcelona Spain 08242

Sponsors and Collaborators

  • Fundació Universitària del Bages

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fundació Universitària del Bages
ClinicalTrials.gov Identifier:
NCT06127888
Other Study ID Numbers:
  • I-RECEPTA JPA003
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 15, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fundació Universitària del Bages
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2023