ClinicalTrials.gg
Enrolling by invitationNCT06127888RECEPTAUpdated Feb 12, 2024

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

An observational study in Migraine, Headache and Chronic Headache, sponsored by Fundació Universitària del Bages. Enrolling by invitation at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-12.

Sponsored by Fundació Universitària del Bages · Observational

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 5 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Migraine
  • Headache
  • Chronic Headache

Keywords

  • Exercise therapy
  • Neurology
  • Headache units
  • Primary headaches
  • Physiotherapy
03

In context

Migraine Disorders

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

This study's planned enrollment of 30 is below the median of 137 across 331 observational studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Fundació Universitària del Bages is the lead sponsor of 7 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Decline participation
  • Unable to understand Catalan, Spanish or English
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
30 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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 · Other: 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: Interviews · Other: 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: Interviews · Other: 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: Interviews · Other: 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: Interviews · Other: Surveys

  • Headache Unit of Hospital de Bellvitge - Barcelona

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

    Other: Interviews · Other: Surveys

  • Headache Unit of Hospital del Mar - Barcelona

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

    Other: Interviews · Other: 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: Interviews · Other: Surveys

  • Headache Unit of Hospital Josep Trueta - Girona

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

    Other: Interviews · Other: Surveys

Interventions

  • OtherInterviews

    Semi-structured interviews

  • OtherSurveys

    Estructured survey

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: During observation period from November 2023 to January 2024.

  2. 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.

    Time frame: During observation period from November 2023 to January 2024.

  3. 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.

    Time frame: During observation period from November 2023 to January 2024.

Secondary outcomes

  1. 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.

    Time frame: During November 2023

  2. Necessary material resources

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

    Time frame: During observation period from November 2023 to January 2024.

  3. Necessary technological resources

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

    Time frame: During observation period from November 2023 to January 2024.

  4. Necessary human resources

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

    Time frame: During observation period from November 2023 to January 2024.

  5. Necessary service resources

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

    Time frame: During observation period from November 2023 to January 2024.

  6. Necessary additional resources

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

    Time frame: During observation period from November 2023 to January 2024.

  7. 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.

    Time frame: December 2023

07

Study locations

1 site
  • University of Manresa
    Manresa, Barcelona 08242, Spain
08

References and documents

Publications

  • 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. PubMed 29161767 ↗
  • 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. PubMed 29333870 ↗
  • 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. PubMed 28750588 ↗
  • 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. PubMed 16886935 ↗
  • 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. PubMed 27491303 ↗
  • 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. PubMed 37410390 ↗
  • 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. PubMed 29678893 ↗
  • 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. PubMed 35077913 ↗
  • 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. PubMed 34769668 ↗
  • 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. PubMed 30789640 ↗
  • 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. PubMed 34083062 ↗
  • 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. PubMed 29368949 ↗

Individual participant data

Plan to share: Undecided — Should be discussed with the participants

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2024; primary completion for May 2024, 2 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2023
First posted
Nov 13, 2023
StartEst.
Mar 20, 2024
Primary completionEst.
May 20, 2024
CompletionEst.
Jun 20, 2024
Last update
Feb 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06127888
Lead sponsor
Fundació Universitària del Bages
Responsible party
Sponsor
First posted
Nov 13, 2023
Start date
Mar 20, 2024 (estimated)
Primary completion
May 20, 2024 (estimated)
Completion
Jun 20, 2024 (estimated)
Last update
Feb 12, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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