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Headache clinical trials

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NCT ID: NCT05249647 Completed - Clinical trials for Cervicogenic Headache

Instrument Based Fascial Abrasion Versus Myofascial Release Technique in Cervicogenic Headache Patients

Start date: January 25, 2022
Phase: N/A
Study type: Interventional

Study will be randomized clinical trial. Data will be collected from non probability consecutive sampling technique. Total 44 participants from Rafiqa Hospital and District Headquarter (DHQ) Sargodha will be selected and randomly allocated to two different groups i.e Group A and Group B. Group A will be treated with Instrument assisted Fascial Abrasion and Conventional Therapy for 5 minutes, 6 sessions (3 sessions per week) (12) while Group B will be treated with Myofascial Release Technique and Conventional Therapy for 2 to 3 minutes, 5-7 repetitions and 3 sessions per week on alternate days were given for 6 weeks. NPRS, MOS-36, NDI will be used as outcome measuring tool before and after treatment. Data will be analyzed by using Statistical package for social sciences 25.

NCT ID: NCT05247333 Completed - Constipation Clinical Trials

Implementation of a Minor Ailment Service in Community Pharmacy Practice

INDICA+PRO
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Self-care and self-medication are commonly the treatments of choice for the management of minor ailments. Minor ailments can be treated through community pharmacy using a Minor Ailment Service (MAS). The INDICA+PRO Impact Study, evaluated the clinical, economic and humanistic impact of a MAS, concluding that community pharmacies could greatly benefit the health system. Thus, the following objectives were defined for the INDICA+PRO implementation study. The primary objective is to implement a standardised MAS in usual practice in community pharmacy in Spain. The secondary objectives include an evaluation of the clinical and economic outcomes and the role and impact of two different models of change agents. A pragmatic study with an effectiveness-implementation hybrid design type 3 will be undertaken using the Framework for the Implementation of Services in Pharmacy (FISpH). The study will be carried between October 2020 and December 2022. Two type of practice change facilitators FaFa and SEFaFa. Their main function, using the Observe-Plan-Do-Study-Act process, will be to facilitate the implementation through individualised continuous support to providers of the MAS. The depth and breadth of support to pharmacist providers by each type of change agents will vary. Pharmaceutical Associations (PA) and/or Spanish Society of Community Pharmacy (SEFAC) will invite community pharmacies/pharmacists. Participating pharmacists will need to sign a commitment form. The second study population will consist of patients presenting with minor ailments or requesting a non-prescription medication. Recruitment of patients will be carried out by the pharmacist providers. The inclusion criteria will be: patients or caregivers (aged ≥18 years, or younger if they are accompanied by an adult) presenting with 31 minor ailments, grouped into five categories (respiratory, moderate pain, digestive, dermatological and other) with pre-agreed referral protocols. Other symptoms may be included at the discretion of the pharmacists. The exclusion criteria will be patients who do not provide informed consent. The patient/pharmacist intervention will consist of a MAS protocol adapted for each symptom. The consultation will be record in an electronic data capture system (SEFAC eXPERT®-) that provides a step-by-step approach with protocols and clinical information embedded. The FISpH model will be used to guide the implementation of MAS. Two types of change agents, FaFas and SeFaFas, previously trained for 18 hours, will be used to facilitate the implementation. During each of the stages (exploration, preparation, testing and operation, and initial sustainability), strategies will be used by FaFas and SeFaFas to moderate implementation factors. The impact of strategies will be evaluated. Data on pharmacy/pharmacist's provider performance and patient outcomes will be provided to pharmacist, change agents and PA and SEFAC. FaFas and SeFaFas will have a classification system for barriers and facilitators derived from the constructs in the Consolidated Framework for Implementation Research (CFIR). The classification system for implementation strategies consists of an adaptation of the facilitation activities listed by Dogherty et al. These will be documented in an electronic data capture system. FaFas will train their pharmacists (max. of 25 pharmacies) for 6 hours and subsequently provide at least monthly follow-up. The research team will provide ongoing feedback and support to the FaFas and SeFaFas through periodically, hold group meetings by video conference between the research group and all the FaFas and SeFaFas. The research group will provide formal reports on the implementation process and patient outcomes. Other forms of communication such as emails, telephone calls or WhatsApp messaging will also be available. Implementation and patient consultation process and outcome variables will be measured such as reach, fidelity and integration. Outcome service indicators will be clinical, economic and humanistic. A patient follow up will occur at a maximum of 10 days. Continuous variables will be reported using mean and standard deviation, or median and percentiles. Categorical variables will be reported using percentages. T Student's test or the ANOVA test or Kruskal-Wallis. χ2 test, Fisher's exact test or Yate's chi-squared will also be used. To determine the relationship between the dependent and the independent variables, logistic regression models will be performed including the variables with statistical significance in the bivariate model. The level of significance will be set at p <0.05. Machine learning and big data techniques are being considered for predictive modelling. The research team will only have access to de-identified data of pharmacists and patients. This study protocol has been approved by the Granada Research Ethics Committee on the 5th February 2020.

NCT ID: NCT05243953 Completed - Clinical trials for Post-Traumatic Headache

Hypersensitivity to Opening of ATP-Sensitive Potassium Channels in Post-Traumatic Headache

Start date: March 21, 2022
Phase: N/A
Study type: Interventional

The aim is to investigate whether opening of ATP-sensitive potassium (KATP) channels induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).

NCT ID: NCT05205590 Completed - COVID-19 Clinical Trials

COVID-19 Pandemic and Migraine Disorder, Tension Headache and Epilepsy

Start date: June 1, 2021
Phase:
Study type: Observational

Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has already rapidly spread around the world as a pandemic after its first report in Wuhan, China on December 12th 2019 ( Holshue ML et al .,2019 ). As of December 27th 2020, there were more than 79.2 million confirmed cases and more than 1.7 million deaths caused by COVID-19 worldwide (WHO,2020). Migraine& tension headacheare considered one of the most disabling chronic neurological diseases, and patients with migraine or tension headache are particularly vulnerable to drastic negative impacts of the pandemic. From heightened levels of psychosocial stress, social isolation , disruption of sleep and dietary habits ,to several COVID-19-specific concerns. Normally, people with epilepsy (PWE)patients are very sensitive to different factors such as physical or emotional disturbances or environmental and lifestyle changes.Many factors can increase the risk of seizures,i.e., illness and fever, stressful events, sleep deprivation,changes in antiepileptic drugs (AED),use of proconvulsive treatments,to name a few.Some are unavoidable during a sociosanitary crisis like that currently being experienced. Because of the rapid increase of infections, Government enacted a national state of emergency, limiting public mobility and compelling home confinement and social isolation. This national lockdown, in addition to the direct effects of COVID-19, have dramatically altered the lifestyle and normal routines of the entire population.Therefore, in addition to the risk of neurological involvement that COVID-19 itself has, during the pandemic,different circumstances may negatively impact on seizure control in PWE.

NCT ID: NCT05204316 Completed - Headache Disorders Clinical Trials

NLP Headache Speech (NLPH-SPEECH): a Cross-sectional Study on Natural Language Processing Analysing Spoken Monologues by Headache Patients

NLPH SPEECH
Start date: January 13, 2022
Phase: N/A
Study type: Interventional

The research collects spoken descriptions of headache disorders by participants with headache disorders. The speech recordings are analyzed by natural language processing (NLP) tools to analyse linguistic properties of the texts and to obtain insight into the potential of NLP machine learning models for the recognition of headache syndromes of the participants.

NCT ID: NCT05199064 Completed - Migraine Clinical Trials

Efficacy of Greater Occipital Nerve Radiofrequency for Refractory Migraine Treatment

Start date: September 15, 2020
Phase:
Study type: Observational

Objective: Ultrasound-guided pulsed radiofrequency therapy can be used on the greateroccipital nerve (GON) in patients with chronic migraine (CM) who are unresponsive to conservative treatments. In this study, we aimed to demonstrate the change in pain intensity, duration of migraine episodes, frequency of attacks,migraine disability, depression,and sleep disturbance scores before and after treatment in patients with CM who underwent ultrasound-guided GON pulsed radiofrequency and the effectiveness of treatment. Patients and methods:The study included 25 patients who were diagnosed as having CMaccording to the International Classification of Headache Disorders III beta version diagnostic criteria. The Migraine Disability Assessment Scale (MIDAS), Beck Depression Inventory(BDI), Pittsburgh Sleep Quality Index (PSQI),and a visual analog scale (VAS) were used on patients before GON pulsed radiofrequency treatment and at post treatment months 1 and 3. Results:The median duration and number of migraine episodes in the post-interventional 1st month and 3rd month were significantly shorter and fewer compared with the pre intervention period (p<0.001). In the comparison with the pre intervention values, all of the scoring concepts, namely the MIDAS, VAS, BDI, and PSQI, revealed a significant drop in the post intervention 1st and 3rd month (p<0.001). Conclusion: In this study, we observed that ultrasound-guided GON pulsed radiofrequency therapy applied at the proximal (C2) level was a safe and effective treatment option.With GON pulsed radiofrequency, we observed a decrease in pain intensity, pain frequency, andduration of episodes, and an improvement in depression symptoms, migraine disability, and sleep disorder scores accompanying chronic migraine.

NCT ID: NCT05153876 Completed - Migraine Disorders Clinical Trials

An Open Internet-based Survey and Natural Language Processing Project Analysing Written Monologues by Headache Patients

NLPH-OPEN
Start date: October 11, 2021
Phase:
Study type: Observational

Headache disorders are among the most prevalent medical conditions worldwide. The diagnosis of headache disorders is based on medical history taking. Digital solutions such as natural language processing (NLP) may be of aid to understand the linguistic aspects of headache attack and headache related disability descriptions by patients. Participants will provide a written description of their headache disorder. The results will hopefully lead to a better understanding of the potential use of NLP in headache disorders.

NCT ID: NCT05108688 Completed - Headache Clinical Trials

Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache

Start date: November 15, 2021
Phase: Phase 4
Study type: Interventional

Postdural puncture headache (PDPH) is a potential complication after spinal anesthesia caused by traction on pain-sensitive structures from low cerebrospinal fluid pressure (intracranial hypotension) following a leak of cerebrospinal fluid at the puncture site. Symptoms of this condition include a bilateral frontal or occipital headache that is worse in the upright position, along with nausea, neck pain, dizziness, visual changes, tinnitus, hearing loss, or radicular symptoms in the arms. This study will examine the efficacy of mirtazapine in in the treatment of PDPH after obstetric surgery under spinal anesthesia and compared its efficacy with that of sumatriptan.

NCT ID: NCT05093582 Completed - Cluster Headache Clinical Trials

The Effects of Levcromakalim in Patients With Cluster Headache

Start date: June 4, 2021
Phase: N/A
Study type: Interventional

Cluster headache is a primary headache disorder characterized by attacks of unilateral headache of short duration and severe pain intensity. There is an unmet need to understand the underlying disease mechanisms that will ultimately lead to the development of disease-specific medicines. Until now, it has been suggested that the calcitonin gene-related peptide (CGRP) plays a major role in the initiation of a cluster headache attack, possibly involving the ATP-sensitive potassium channels. The current study aims to determine whether the opening of ATP-sensitive potassium channels triggers cluster headache attacks in patients with cluster headache.

NCT ID: NCT05085483 Completed - Migraine Headache Clinical Trials

Ketone for Migraine Prevention

Start date: October 11, 2021
Phase: N/A
Study type: Interventional

Efficacy of a nutritional ketogenic supplement (NKS) in reducing the number, intensity, and duration of migraine headaches in episodic migraine patients.