MigraineRECEPTANCT06127888
Impementation of the Exercise Recommendations for the Treatment of Primary Headaches: A Qualitative Approach to the Headache Units in Catalonia
An observational study of Migraine and Headache, run by Fundació Universitària del Bages at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Migraine, Headache, Chronic Headache
- What is being tested?
- Interviews and Surveys
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 20 Mar 2024to 20 Jun 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Neurologists, nurses, pharmacists, researchers, physical therapists, rehabilitation doctors, health manager of the headache unit or rehabilitation service connected to the headache unit.
Who may be able to join
- 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.
Who cannot join
- Decline participation
- Unable to understand Catalan, Spanish or English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Migraine, Headache, Chronic Headache
- Being tested
- Interviews, Surveys
- Keywords
- Exercise therapy, Neurology, Headache units, Primary headaches, Physiotherapy
- Medical subject headings
- Migraine Disorders, Headache, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewsOther
Semi-structured interviews
SurveysOther
Estructured survey
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Interviews; Other: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: During observation period from November 2023 to January 2024.
Secondary outcomes (7)
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.
Measured: During November 2023
Necessary material resources
List of material resources needed for implementing physiotherapy in the headache units. Identified through semi-structured interviews.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start20 Mar 2024 (estimated)
- Primary completion20 May 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fundació Universitària del Bages
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127888
- Sponsor's protocol ID
- I-RECEPTA JPA003
- Acronym
- RECEPTA
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Should be discussed with the participants
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 29161767Kroll 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 29333870Madsen 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 28750588van 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 16886935Alvarez-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 27491303Reina-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 37410390Miyamoto 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 29678893Del 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 35077913Salazar 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 34769668Jimenez-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 30789640Headache 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementació de Recomanacions d'Exercici Per al Tractament de Les Cefalees primàries: Una aproximació Qualitativa a Les Unitats de Cefalea a Catalunya
- ClinicalTrials.gov ID
- NCT06127888
- Acronym / sponsor ID
- RECEPTA / I-RECEPTA JPA003
- Conditions
- Migraine, Headache, Chronic Headache
- Keywords
- Exercise therapy, Neurology, Headache units, Primary headaches, Physiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundació Universitària del BagesUniversity, hospital or other
- Study start
- 20 Mar 2024 (estimated)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Unit of headache and neurological pain of the Hospital Vall d'Hebron (VHIR) - Barcelona | – | Other: Interviews, Other: SurveysNeurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit. |
| Unit of headaches and neuralgias of the Hospital de Sant Pau - Barcelona | – | Other: Interviews, Other: SurveysNeurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit. |
| Unit of headache of the Hospital Sant Joan de Déu - Althaia - Manresa | – | Other: Interviews, Other: SurveysNeurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit. |
| Unit of headache of the Hospital Universitari Arnau de Vilanova - Lleida | – | Other: Interviews, Other: SurveysNeurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit. |
| Group of work on headaches of the Hospital Clínic de Barcelona | – | Other: Interviews, Other: SurveysNeurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit. |
| Headache Unit of Hospital de Bellvitge - Barcelona | – | Other: Interviews, Other: SurveysNeurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit. |
| Headache Unit of Hospital del Mar - Barcelona | – | Other: Interviews, Other: SurveysNeurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit. |
| Headache Unit of Hospital de Germans Tries i Pujol - Can Ruti - Badalona | – | Other: Interviews, Other: SurveysNeurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit. |
| Headache Unit of Hospital Josep Trueta - Girona | – | Other: Interviews, Other: SurveysNeurologists, nurses, pharmacists, health managers, physiotherapists, and other healthcare professionals related to the headache unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Neurologists, nurses, pharmacists, researchers, physical therapists, rehabilitation doctors, health manager of the headache unit or rehabilitation service connected to the headache unit.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Decline participation
- Unable to understand Catalan, Spanish or English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewsSemi-structured interviews | Other | Group of work on headaches of the Hospital Clínic de Barcelona, Headache Unit of Hospital Josep Trueta - Girona, Headache Unit of Hospital de Bellvitge - Barcelona, Headache Unit of Hospital de Germans Tries i Pujol - Can Ruti - Badalona, Headache Unit of Hospital del Mar - Barcelona, Unit of headache and neurological pain of the Hospital Vall d'Hebron (VHIR) - Barcelona, Unit of headache of the Hospital Sant Joan de Déu - Althaia - Manresa, Unit of headache of the Hospital Universitari Arnau de Vilanova - Lleida, Unit of headaches and neuralgias of the Hospital de Sant Pau - Barcelona |
| SurveysEstructured survey | Other | Group of work on headaches of the Hospital Clínic de Barcelona, Headache Unit of Hospital Josep Trueta - Girona, Headache Unit of Hospital de Bellvitge - Barcelona, Headache Unit of Hospital de Germans Tries i Pujol - Can Ruti - Badalona, Headache Unit of Hospital del Mar - Barcelona, Unit of headache and neurological pain of the Hospital Vall d'Hebron (VHIR) - Barcelona, Unit of headache of the Hospital Sant Joan de Déu - Althaia - Manresa, Unit of headache of the Hospital Universitari Arnau de Vilanova - Lleida, Unit of headaches and neuralgias of the Hospital de Sant Pau - Barcelona |
Primary outcome
Status of exercise prescription in primary headaches
Time frame: 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.
Viability of the exercise prescription in the headache units
Time frame: 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.
Relevance of exercise as a strategy for the treatment of patients with primary headaches.
Time frame: 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.
7 secondary outcomes
Create a survey for assessing headache unit resources.
Time frame: During November 2023
Necessary material resources
Time frame: During observation period from November 2023 to January 2024.
Necessary technological resources
Time frame: During observation period from November 2023 to January 2024.
Necessary human resources
Time frame: During observation period from November 2023 to January 2024.
Necessary service resources
Time frame: During observation period from November 2023 to January 2024.
Necessary additional resources
Time frame: During observation period from November 2023 to January 2024.
Acceptance to implementation therapeutic exercice strategies
Time frame: December 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Results publication: PubMed 29161767Hanssen 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.
- Results publication: PubMed 29333870Kroll 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.
- Results publication: PubMed 28750588Madsen 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.
- Results publication: PubMed 16886935van 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.
- Results publication: PubMed 27491303Alvarez-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.
- Results publication: PubMed 37410390Reina-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.
- Results publication: PubMed 29678893Miyamoto 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.
- Results publication: PubMed 35077913Del 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.
- Results publication: PubMed 34769668Salazar 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.
- Results publication: PubMed 30789640Jimenez-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.
- Results publication: PubMed 29368949Headache 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.
- Individual participant dataSharing planned: Undecided. Should be discussed with the participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Headache, run by Fundació Universitària del Bages at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Status of exercise prescription in primary headaches (time frame: During observation period from November 2023 to January 2024.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06127888, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.