Does pain self-efficacy predict, moderate or mediate outcomes in people with chronic headache; an exploratory analysis of the CHESS trial.

BACKGROUND: Chronic headache disorders are disabling. The CHESS trial studied the effects of a short non-pharmacological intervention of education with self-management support for people affected by migraine and/or tension type headache for at least 15 days per month for at least three months. There were no statistically significant effects on the Headache Impact Test-6 (HIT-6) at 12-months. However, we observed improvement in pain self-efficacy questionnaire (PSEQ) and short-term HIT-6. We explored the impact of the CHESS intervention on PSEQ, and subsequently, on the HIT-6 and chronic headache quality of life questionnaire (CH-QLQ) at four, eighth and 12 months. METHODS: We included all 736 participants from the CHESS trial. We used simple linear regression models to explore the change of HIT-6 and CH-QLQ with treatment and PSEQ at baseline (predictor analysis), and the interaction between treatment and baseline PSEQ (moderator analysis). We considered the change of PSEQ from baseline to four months as a mediator in the mediation analysis. RESULTS: Baseline PSEQ neither predicted nor moderated outcomes. The prediction effect on change of HIT-6 from baseline to 12 months was 0.01 (95% CI, -0.03 to 0.04) and the interaction (moderation) effect was -0.07 (95% CI, -0.15 to 0.002). However, the change of PSEQ from baseline to 4-month mediated the HIT-6 (baseline to 8-, and 12-month) and all components of CH-QLQ (baseline to 8-, and 12-month). The CHESS intervention improved the mediated variable, PSEQ, by 2.34 (95% CI, 0.484 to 4.187) units and this corresponds to an increase of 0.21 (95% CI, 0.03 to 0.45) units in HIT-6 at 12-months. The largest mediated effect was observed on the CH-QLQ Emotional Function, an increase of 1.12 (95% CI, 0.22 to 2.20). CONCLUSIONS: PSEQ was not an effective predictor of outcome. However, change of short-term PSEQ mediated all outcomes, albeit minimally. Future behavioural therapy for chronic headache may need to consider how to achieve larger, and more sustained increases level of self-efficacy than that achieved within the CHESS trial. TRIAL REGISTRATION: ISRCTN79708100.

Sphenopalatine ganglion stimulation: a comprehensive evaluation across diseases in randomized controlled trials.

Background: Current literature extensively covers the use of sphenopalatine ganglion stimulation (SPGs) in treating a broad spectrum of medical conditions, such as allergic rhinitis, cluster headaches, and strokes. Nevertheless, a discernible gap in the systematic organization and analysis of these studies is evident. This paper aims to bridge this gap by conducting a comprehensive review and analysis of existing literature on SPGs across various medical conditions. Methods: This study meticulously constructed a comprehensive database through systematic computerized searches conducted on PubMed, Embase, CNKI, Wanfang, VIP, and CBM up to May 2022. The inclusion criteria encompassed randomized controlled trials (RCTs) published in either Chinese or English, focusing on the therapeutic applications of SPGs for various medical conditions. Both qualitative and quantitative outcome indicators were considered eligible for inclusion. Results: This comprehensive study reviewed 36 publications, comprising 10 high-quality, 23 medium-quality, and three low-quality articles. The study investigated various diseases, including allergic rhinitis (AR), ischemic strokes (IS), cluster headache (CH), primary trigeminal neuralgia (PTN), pediatric chronic secretory otitis (PCSO), refractory facial paralysis (RFP), chronic tension-type headache (CTTH), as well as the analysis of low-frequency sphenopalatine ganglion stimulation (LF-SPGs) in chronic cluster headache (CCH) and the impact of SPGs on Normal nasal cavity function (NNCF). SPGs demonstrate efficacy in the treatment of AR. Regarding the improvement of rhinoconjunctivitis quality of life questionnaire (RQLQ) scores, SPGs are considered the optimal intervention according to the SUCRA ranking. Concerning the improvement in Total Nasal Symptom Score (TNSS), Conventional Acupuncture Combined with Tradiational Chinese Medicine (CA-TCM) holds a significant advantage in the SUCRA ranking and is deemed the best intervention. In terms of increasing Effective Rate (ER), SPGs outperformed both conventional acupuncture (CA) and Western Medicine (WM; P < 0.05). In the context of SPGs treatment for IS, the results indicate a significant improvement in the 3-month outcomes, as evaluated by the modified Rankin Scale (mRS) in the context of Cerebral Cortical Infarction (CCI; P < 0.05). In the treatment of CH with SPGs, the treatment has been shown to have a statistically significant effect on the relief and disappearance of headaches (P < 0.05). The impact of SPGs on NNCF reveals statistically significant improvements (P < 0.05) in nasal airway resistance (NAR), nasal cavity volume (NCV), exhaled nitric oxide (eNO), substance P (SP), vasoactive intestinal peptide (VIP) and neuropeptide Y (NPY). SPGs treatments for PCSO, RFP, and CTTH, when compared to control groups, yielded statistically significant results (P < 0.05). Conclusion: SPGs demonstrate significant effectiveness in the treatment of AR, IS, and CH. Effective management of CCH may require addressing both autonomic dysregulation and deeper neural pathways. However, additional high-quality research is essential to clarify its effects on NNCF, PTN, PCSO, RFP, and CTTH. Systematic Review Registration: PROSPERO, identifier CRD42021252073, https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=312429.

Differences in musculoskeletal dysfunctions and in postural alterations between chronic migraine and chronic tension type headache: A cross-sectional study.

OBJECTIVE: The aim of present study is to assess postural alterations and musculoskeletal dysfunctions over all spine in patients with chronic migraine and chronic tension type headache, moreover to highlight the differences between these two forms of primary headache. METHODS: A Cross sectional study was adopted to evaluate the musculoskeletal profile in patients with chronic migraine and with chronic tension type headache. The Bio photogrammetric evaluation was performed using the postural assessment software PAS/SAPO, while unilateral passive accessory intervertebral motion (PAIMs) were applied for manual examinations of spine segments from C0 to L5 vertebra. The One-way Analysis of Variance (ANOVA) test was used to compare the three groups with the software GraphPad InStat 3.06. RESULTS: A total of 60 patients were recruited, 20 for chronic tension type group, 20 for chronic migraine group and 20 healthy controls. The most interesting findings was that patients with chronic primary headaches presented postural alterations in all parameters (cranio-vertebral angle and lumbar-pelvic angle) and musculoskeletal dysfunctions in all spine with respect to healthy controls. Finally, the most clinically relevant finding was that no differences were found between chronic migraine and chronic tension type headache concerning the postural alterations nor the musculoskeletal dysfunctions. CONCLUSION: The sensitization acts as a substrate or consequence of these musculoskeletal dysfunctions in chronic primary headache. Therefore, non-pharmacological treatments targeted in the musculoskeletal system may be a good option in the management of chronic primary headache, especially when these therapies integrate various techniques that involve all spine.

Disease-Related Factors Associated with Acupuncture Response in Patients with Chronic Tension-Type Headache: A Secondary Analysis of A Randomized Controlled Trial.

OBJECTIVE: To explore the demographic and disease-related factors associated with acupuncture response in patients with chronic tension-type headache (CTTH). METHODS: Using data from a randomized clinical trial (218 cases) consisting of 4 weeks of baseline assessment, 8 weeks of treatment, and 24 weeks of follow-up, participants were regrouped into responders (at least a 50% reduction in monthly headache days at week 16 compared with baseline) and non-responders. Twenty-three demographic and disease-related factors associated with acupuncture response in 183 participants were analyzed by multivariable logistic regression. RESULTS: One hundred and nineteen (65.0%) participants were classified as responders. Four factors were significantly independently associated with acupuncture response, including treatment assignment, headache intensity at baseline, and 2 domains [general health (GH) and social functioning (SF)] from the 36-Item Short Form Health Survey quality of life questionnaire. Treatment assignment was associated with non-response: participants receiving true acupuncture were 3-time more likely to achieve a CTTH response than those receiving superficial acupuncture [odds ratio (OR) 0.322, 95% confidence interval (CI) 0.162 to 0.625, P=0.001]. Compared with patients with mild-intensity headache, patients with moderate-intensity headache were twice as likely to respond to acupuncture (OR 2.001, 95% CI 1.020 to 4.011, P=0.046). The likelihood of non-response increased by 4.5% with each unit increase in the GH grade (OR 0.955, 95% CI 0.917 to 0.993, P=0.024) while decreased by 3.8% with each unit increase in the SF grade (OR 1.038, 95% CI 1.009 to 1.069, P=0.011). CONCLUSIONS: Greater headache intensity, lower GH score, and higher SF score were associated with better acupuncture responses in CTTH patients. These 3 factors require independent validation as predictors of acupuncture effectiveness in CTTH.

Low-Frequency Repetitive Transcranial Magnetic Stimulation for Chronic Tension-Type Headache: A Randomized Controlled Study.

BACKGROUND: Nearly 1-3% of the population is affected by chronic tension-type headaches (CTTH). However, it is still difficult to treat owing to the lack of knowledge of the disease's pathophysiology. Available literature suggests a role for pericranial muscle activity and abnormal modulation of central pain. Repetitive transcranial magnetic stimulation (rTMS) therapy done at the dorsolateral prefrontal cortex (DLPFC) can help modulate pericranial muscle overactivity and central pain modulation in subjects with CTTH. AIM: This randomized controlled study aimed to assess the effect of rTMS used in the low-frequency dorsolateral prefrontal cortex on pain and muscle activity in subjects with a chronic tension-type headache. MATERIALS AND METHODS: The present randomized controlled clinical study was commenced in a health care center on 20 subjects with chronic tension-type headaches who were given either sham or low-frequency repetitive transcranial magnetic stimulation at the right dorsolateral prefrontal cortex. The therapy effect was evaluated statistically using Welch's corrected t-test. RESULTS: The study results depicted that daily use of rTMS therapy for two weeks led to a considerable reduction in the intensity of the pain, the activity of pericranial muscles, and headache impact, along with an increase in the nociceptive excitability thresholds in subjects with CTTH, with p=0.001 compared to the sham group. CONCLUSION: Considering its limitations, the present study depicts that rTMS is an efficacious management tool for reducing pain associated with CTTH and can serve as the cornerstone for additional investigations.

Psychiatric Comorbidity and Emotional Dysregulation in Chronic Tension-Type Headache: A Case-Control Study.

BACKGROUND: Chronic tension-type headache (CTTH) is frequently associated with a psychiatric comorbidity of depression and anxiety. Most studies focus their attention on this association, and only few link CTTH with psycho-affective emotional regulation disorders. OBJECTIVE: To evaluate the association of CTTH with anxiety, depression, positive and negative affectivity, and emotional management in CTTH patients with neither a previous diagnosis of psychiatric disorder nor use of psychoactive drugs or abuse of analgesics. DESIGN: Case-control study. METHODS: Validated scores for state and trait anxiety, depression, positive and negative state and trait affect, cognitive reappraisal, and expressive suppression were assessed in 40 subjects with CTTH and 40 healthy subjects. Associations between CTTH and psychological status were assessed through linear multivariate regression models. RESULTS: CTTH was associated with higher scores for depression (Beta = 5.46, 95% CI: 1.04-9.88), state and trait anxiety (Beta = 12.77, 95% CI: 4.99-20.56 and Beta = 8.79, 95% CI: 2.29-15.30, respectively), and negative state affect (Beta = 5.26, 95% CI: 0.88-9.64). CONCLUSIONS: CTTH is directly associated with depression, anxiety, and negative affectivity signs despite the absence of a previously diagnosed psychiatric disorder or psychopharmacological intake. The recognition of these comorbid and psycho-affective disorders is essential to adapt the emotional management of these patients for better control.

The Efficacy of Japanese Herbal Kampo Medicine as an Acute and Prophylactic Medication to Treat Chronic Daily Headache and Medication Overuse Headache:-Single Arm Retrospective Study.

Introduction A chronic daily headache (CDH) comprises a group of headaches occurring at least 15 days per month for three or more consecutive months. We retrospectively investigated the effectiveness of the hybrid treatment strategy for CDH using Kampo medicine combined with Western medication. Methods We retrospectively investigated 43 consecutive first-visit CDH patients. In addition to Western acute and prophylactic medications, we prescribed three types of Kampo medicines: goreisan, goshuyuto, and kakkonto depending on the patients' symptoms. Headache impact test-6 (HIT-6), monthly headache days (MHD), monthly migraine days (MMD), and monthly acute medication intake days (AMD) before, 1- and 3-months after starting the hybrid medications were assessed as outcomes. Results Thirty-six women and seven men were included. The median age was 51 years old. Nine were chronic migraine (CM), 22 were episodic migraine and tension-type headaches (EM+TTH), and 12 were chronic TTH. Twenty-seven patients also had medication overuse headaches (MOH). The medians of HIT-6 before, one and three months after treatment were 63, 48, and 40, respectively. Those of MHD were 20, 5, and 2. Those of MMD were 2, 0, and 0. Those of AMD were 15, 0, and 0. Significant reductions in HIT-6, MDH, MMD, and AMD were observed one and three months after starting Kampo treatment. Similar trends were observed in the EM+TTH and MOH patients as subgroup analyses. Conclusion The hybrid medication strategy of Kampo and Western medicines for CDH is safe and effective in terms of both acute and prophylactic medications with rapid efficacy.

Sensory Thresholds and Peripheral Nerve Responses in Chronic Tension-Type Headache and Neuropsychological Correlation.

Chronic tension-type headache (CTTH) is a common disease with no fully defined pathophysiological processes. We designed a study to value electrophysiological responses in these patients and their correlation with possible psychopathological manifestations in order to deepen understanding of central and peripheral mechanisms of CTTH. In 40 patients with CTTH and 40 healthy controls, we used electrical stimulation to determine sensory threshold (SPT) and pain perception threshold (PPT) and the characteristics of the electrophysiological sensory nerve action potential (SNAP): initial sensory response (ISR) and supramaximal response (SMR). We then calculated the intensity differences between thresholds (IDT), namely SPT-PPT, ISR-SMR and SMR-PPT, and correlated these IDTs with psychological characteristics: trait and state anxiety, depression, and emotional regulation. The SPT, together with the ISR and SMR thresholds, were higher (p < 0.01) in CTTH patients. The SMR-PPT IDT was smaller and correlated with significantly higher indicators of depression, state and trait anxiety, and poorer cognitive reappraisal. CTTH patients have less capacity to recognize non-nociceptive sensory stimuli, greater tendency toward pain facilitation, and a poor central pain control requiring higher stimulation intensity thresholds to reach the start and the peak amplitude of the SNAP. This is consistent with relative hypoexcitability of the Aß nerve fibers in distant regions from the site of pain, and therefore, it could be considered a generalized dysfunction with a focal expression. Pain facilitation is directly associated with psychological comorbidity.

Time to retire 'New daily persistent headache': Mode of onset of chronic migraine and tension-type headache.

New daily persistent headache is described as an enigmatic condition with daily headache from onset. It has posed challenges diagnostically and therapeutically.Methods: We conducted a study of patients referred to headache services based in Central and North-East London, United Kingdom, meeting the International Classificaiton of Headache Disorders - 3 criteria for New daily persistent headache. Information on demographics, phenotype and treatment responses were collected. The syndrome of the daily headache was also classified according any other ICHD-3-defined syndrome.Results: Of 162 patients, females comprised 68.5% with median age of onset 35 years. The daily headache experienced was chronic migraine in 89.7% and tension-type headache in 8.8%. Thunderclap-onset New daily persistent headache occurred in 14.8%. More than one headache syndrome was experienced in 15.4%, including cough, hypnic, sexual and stabbing headache. All aura types were experienced, most commonly brainstem aura in 39%. Prior headache was reported 53.7%. A persisting sub-form was present in 51.2%, relapsing remitting in 12.3% and 14.0% reported improvement; 19.8% were lost to follow-up. Only 11.1% reported an antecedent trigger. The most common premorbid disorders were psychiatric in 35.7%. A fifth improved on preventative medication, most commonly amitriptyline, propranolol and topiramate.Conclusion: Our cohort of New daily persistent headache is consistent with a mode of onset of migraine and tension-type headache which occurs in predisposed individuals.

Is new daily persistent headache a fallout of somatization? An observational study.

OBJECTIVE: New daily persistent headache (NDPH) is characterized by daily, persistent headache with clearly remembered onset, preceding events or triggers and treatment refractoriness of headache. The pathophysiology of NDPH is still unresolved. NDPH has been associated with somatoform disorder (DSM 4 TR). Somatization is characterized by vivid memory, disproportionate and persistent thought about symptoms that may explain many characteristics of NDPH. However, tendency towards somatization has not been studied in NDPH patients. METHODS: In this cross-sectional study, we evaluated somatization in NDPH, chronic migraine (CM), and chronic tension type headache (CTTH) by comparing the prevalence of somatic symptom disorder (SSD, DSM-5). We evaluated the past tendencies to somatization by comparing various characteristics of past somatic symptoms (number, duration, type, clearly remembered onset, etc.) between NDPH, CM, and CTTH. RESULTS: Forty-seven patients each of NDPH and CTTH and 46 patients of CM were evaluated. Criteria for SSD was fulfilled by 85.1% of NDPH and CTTH patients and only 45.7% of CM. Past history of somatic symptoms was seen in 70% patients with NDPH, 15.2% CM, and 23.4% CTTH (p<0.001). Median number of past somatic symptoms was higher in NDPH. All NDPH patients clearly remembered the onset of at least one past somatic symptom. None of CM and CTTH patients remembered the onset of past somatic symptoms. CONCLUSION: NDPH patients displayed significant past history of somatization. Continuation of past tendencies to manifest as NDPH suggests that NDPH may be an epiphenomenon of somatization.

The efficacy of botulinum toxin A treatment for tension-type or cervicogenic headache: a systematic review and meta-analysis of randomized, placebo-controlled trials.

OBJECTIVES: The pathogeneses of chronic tension-type headache (CTTH) and cervicogenic headache (CEH) are not well established. Peripheral activation or sensitization of myofascial nociceptors is suggested as a potential mechanism and injections of botulinum toxin (BONTA) have thus been used in the treatment for both headache conditions. BONTA inhibits the release of acetylcholine at the neuromuscular junction and inhibits contraction of skeletal muscles. If the pain is precipitated by increased tone in cervical muscles, local injections of BONTA could represent a prophylactic measure. However, the treatment is still controversial, and a thorough assessment of the current evidence is required. This review aims to assess the evidence of BONTA injection as a prophylactic treatment for CTTH and CEH by reviewing and examining the quality of placebo-controlled, randomized trials. METHODS: Data sources: we searched in the following databases: PubMed (including Medline), Embase, Cochrane Central register of Controlled Trials, Cinahl, Amed, SCOPUS and Google Scholar including other repository sources. Both MeSH and free keywords were used in conducting the systematic search in the databases. The search covered publications from the root of the databases to November 2020. STUDY ELIGIBILITY CRITERIA: The review included RCTs, comparing single treatment of BONTA with placebo on patients with CTTH or CEH above 18 years of age, by measuring pain severity/relief or headache frequency. DATA EXTRACTION: The following data were extracted: year of publication, country, setting, trial design, number of participants, injection procedure, BONTA dosages, and clinical outcome measures. STUDY APPRAISAL: To assess validity and quality, and risk of bias, the Oxford Pain Validity Scale, Modified Jadad Scale, last version of Cochrane Collaboration's tool for assessing risk of bias (RoB 2), and the CONSORT 2010 Checklist were used. The trials were assessed, and quality scored independently by two of the reviewers. A quantitative synthesis and meta-analyses of headache frequency and intensity were performed. RESULTS: We extracted 16 trials, 12 on prophylactic BONTA treatment for CTTH and four on CEH. Of these 12 trials (8 on CTTH and 4 on CEH) were included in the quantitative synthesis. A majority of the trials found no significant difference on the primary outcome measure when BONTA treatment was compared with placebo. Three "positive" trials, reporting significant difference in favor of BONTA treatment, but two of these were hampered by low validity and quality scores and high risk of bias. CONCLUSIONS: There is no clear clinical evidence supporting prophylactic treatment with BONTA for CTTH or CEH.

The effect of suboccipital muscle inhibition and posture correction exercises on chronic tension-type headaches.

BACKGROUND: Compared with healthy people, patients with chronic tension-type headache (CTTH) are likely to have forward head postures (FHP) and a higher number of active trigger points (aTrP) on the suboccipital muscle. OBJECTIVE: This study aims to verify how the suboccipital muscle inhibition (SMI) on aTrPs and the FHP correction exercise can effectively reduce symptoms of the CTTH patients. METHOD: The subjects of this study were 45 individuals with CTTH, divided into three groups of 15 patients each: a) the SMI group using the myofascial release technique; b) the SMIEx group subject to both the SMI therapy and FHP correction exercises; and c) the control group. Group A and B were given the relevant interventions twice a week for four consecutive weeks, and went through the headache impact test (HIT-6) and examinations on the pressure pain threshold (PPT) of the headache areas, the type and number of myofascial trigger points (TrP), the soft tissue PPT, and the posture before and after the intervention. RESULTS: There was a significant improvement in the HIT-6, the headache PPT, the soft tissue PPT, the TrP, and the posture in Group A and B patients to whom the SMI technique and SMIEx interventions were applied. The biggest reduction and increase in the HIT-6 and the headache PPT respectively were seen in the SMIEx group. CONCLUSION: According to this study, the SMIEx can be an effective intervention for patients with CTTH.

Advances in the Understanding of Pathophysiology of TTH and its Management.

BACKGROUND: Tension-type headache (TTH) is the most common form of primary headache. OBJECTIVE: The aim of this study was to document and summarize the advances in the understanding of TTH in terms of pathogenesis and management. MATERIAL AND METHODS: We reviewed the available literature on the pathogenesis and management of TTH by searches of PubMed between 1969 and October 2020, and references from relevant articles. The search terms "tension-type headache", "episodic tension-type headache", chronic tension-type headache, "pathophysiology", and "treatment" were used. RESULTS: TTH occurs in two forms: episodic TTH (ETTH) and chronic TTH (CTTH). Unlike chronic migraine, CTTH has been less thoroughly studied and is a more difficult headache to treat. Frequent ETTH and CTTH are associated with significant disability. The pathogenesis of TTH is multifactorial and varies between the subtypes. Peripheral mechanism (myofascial nociception) and environmental factors are possibly more important in ETTH, whereas genetic and central factors (sensitization and inadequate endogenous pain control) may play a significant role in the chronic variety. The treatment of TTH consists of pharmacologic and non-pharmacologic approaches. Simple analgesics like NSAIDs are the mainstays for acute management of ETTH. CTTH requires a multimodal approach. Preventive drugs like amitriptyline or mirtazapine and non-pharmacologic measures like relaxation and stress management techniques and physical therapies are often combined. Despite these measures, the outcome remains unsatisfactory in many patients. CONCLUSION: There is clearly an urgent need to understand the pathophysiology and improve the management of TTH patients, especially the chronic form.

Intravenous Chlorpromazine as Potentially Useful Treatment for Chronic Headache Disorders.

OBJECTIVE: The aim of this study was to describe a group of patients with chronic headache disorders (CH) and medication overuse headache (MOH) treated with intravenous chlorpromazine (IVC). We hypothesized that IVC is an effective and safe addition to well-known treatment strategies for CH and MOH management. INTRODUCTION: Up to 4% of the general population could experience CH. Most cases occur in women, in association with MOH. To date, evidence to support different treatment strategies is lacking. Although IVC is frequently used in the emergency room (ER), documentation on its use as supportive treatment for CH and for withdrawal management of MOH is poor. METHODS: A retrospective cohort of patients hospitalized to receive treatment for CH in a specialized neurological center in Argentina was analyzed. RESULTS: A total of 35 CH patients were included. Of the 35 patients, 33 (94%) patients also presented MOH. Patients reported only minor side effects to IVC administration (mainly drowsiness and symptomatic hypotension). Three months after inpatient treatment, the number of ER visits made by these patients decreased from an average of 2.8 in the 3 months prior to hospitalization to 0.7 after it (72%, P = .009). Headache frequency decreased in 20/34 (59%) patients during the same time period. Pain levels had dropped from a mean of 8 points at admission (in the scale of 1-10) to 2 points at discharge. In the first 3 months of follow-up, the average number of days per month in which patients experienced headache decreased from 28.9 to 15.4 days (53.3%, P < .0001). CONCLUSION: In this particular group of inpatients, there were no significant safety issues with IVC administration and the study might suggest that the efficacy of IVC as an add-on treatment for CH and MOH.

[Sleep quality in women with chronic tension type headache: an observational study]. / Kachestvo sna u zhenshchin, stradayushchikh khronicheskoi golovnoi bol'yu napryazheniya: observatsionnoe issledovanie.

OBJECTIVE: To investigate sleep quality parameters and their correlations with clinical characteristics in chronic tension type headache (CTTH). MATERIAL AND METHODS: One hundred and sixty-one women with CTTH were enrolled. Sleep quality and Pittsburgh Sleep Quality Index components, headache frequency (HF), headache duration (HD), headache intensity (HI), pericranial muscle tenderness (PMT), widespread pain index (WPI), anxiety and depression were evaluated. RESULTS: The prevalence of poor sleep quality (PSQI total score >5) was 94%. PSQI total score was significantly correlated (p<0.001) with HF (r=0.39), HI (r=0.36), PMT (r=0.32), WPI (r=0.52), and depression (r=0.54). Daytime dysfunction, the decrease in subjective sleep quality and the decrease in habitual sleep efficiency from mild to severe sleep disturbance were most prevalent: 70%, 69%, and 61%, respectively. Each of these parameters was correlated positively with characteristics of pain frequency and intensity. The relative insufficiency of sleep quantity had the prevalence 2.23 times as high as reduced sleep duration: 61% and 27%, respectively (p<0.001). CONCLUSIONS: CTTH is characterized by the decrease in sleep quality parameters, the main of which are Daytime dysfunction, Subjective sleep quality and Habitual sleep efficiency. Patients with CTTH characterize their sleep as: 1) of «bad¼ subjective quality, 2) non-restorative, 3) due to the relative insufficiency of its quantity.

Guideline on the preventive treatment of chronic migraine, chronic tension type headache, hemicrania continua and new daily persistent headache on behalf of the Colombian Association of Neurology / Guía de la Asociación Colombiana de Neurología para el tratamiento preventivo de la migraña crónica, cefalea tipo tensión crónica, hemicránea continua y cefalea diaria persistente de novo

SUMMARY INTRODUCTION: Chronic daily headache is a high impact entity in the general population. Although chronic migraine and tension-type headache are the most frequent conditions, it is necessary to consider hemicrania continua and new daily persistent headache as part of the differential diagnoses to perform a correct therapeutic approach. OBJECTIVE: To make recommendations for the treatment of chronic daily headache of primary origin METHODOLOGY: The Colombian Association of Neurology, by consensus and Grade methodology (Grading of recommendations, assessment, development and evaluation), presents the recommendations for the preventive treatment of each of the entities of the daily chronic headache of primary origin group. RESULTS: For the treatment of chronic migraine, the Colombian Association of Neurology recommends onabotulinum toxin A, erenumab, topiramate, flunarizine, amitriptyline, and naratriptan. In chronic tension-type headache the recommended therapeutic options are amitriptyline, imipramine, venlafaxine and mirtazapine. Topiramate, melatonin, and celecoxib for the treatment of hemicrania continua. Options for new daily persistent headache include gabapentin and doxycycline. The recommendations for inpatient treatment of patients with chronic daily headache and the justifications for performing neural blockades as a therapeutic complement are also presented. CONCLUSION: The therapeutic recommendations for the treatment of chronic daily headache based on consensus methodology and Grade System are presented.

RESUMEN INTRODUCCIÓN: La cefalea crónica diaria es una entidad de alto impacto en la población general. Aunque la migraña crónica y la cefalea tipo tensión son las condiciones más frecuentes, es necesario considerar la hemicránea continua y la cefalea diaria persistente de novo como parte de los diagnósticos diferenciales para realizar un enfoque terapéutico correcto. OBJETIVO: Hacer recomendaciones para el tratamiento de la cefalea crónica diaria de origen primario METODOLOGÍA: La Asociación Colombiana de Neurología, mediante consenso y metodología GRADE (Grading of Reccomendations, Assesment, Development and Evaluation), presenta las recomendaciones para el tratamiento preventivo de cada una de las entidades del grupo de la cefalea crónica diaria de origen primario. RESULTADOS: Para el tratamiento de la migraña crónica, la Asociación Colombiana de Neurología recomienda onabotulinum toxina A, erenumab, galcanezumab, fremanezumab, topiramato, flunarizina, amitriptilina y naratriptan. En cefalea tipo tensional crónica las opciones terapéuticas recomendadas son amitriptilina, imipramina, venlafaxina y mirtazapina. Para el tratamiento de la hemicránea continua topiramato, melatonina y celecoxib. Las opciones para cefalea diaria persistente de novo incluyen gabapentin y doxiciclina. Se presentan adicionalmente las recomendaciones para el tratamiento intrahospitalario de los pacientes con cefalea crónica diaria y las justificaciones para la realización de bloqueos neurales como complemento terapéutico. CONCLUSIÓN: se presentan las recomendaciones terapéuticas para el tratamiento de la cefalea crónica diaria basado en metodología de consenso y sistema GRADE.

The cost and the value of treatment of medication overuse headache in Italy: a longitudinal study based on patient-derived data.

BACKGROUND AND PURPOSE: The cost of medication overuse headache (MOH) is underestimated. Our aim was to address the cost-effectiveness of a structured treatment protocol and to present annual cost estimates. METHODS: Patients were enrolled on the occasion of a structured treatment protocol, were administered a research protocol addressing direct and indirect costs and were followed up for 3 months. RESULTS: Of 176 enrolled patients, 138 completed the study. The 3-month cost per patient fell from €2989 to €1160: the difference was €696 per month for patients treated in the ward and €466 for those treated in day-hospital; thus it takes 2-3 months to compensate for the protocol's cost. The per-person annual costs of MOH were €10 533 (95% confidence interval €8700-12 406): direct healthcare costs accounted for 44.8% and indirect costs for 51.5% of the total MOH cost. The annual MOH cost for Italy is estimated at €13.5 billion (95% confidence interval €11.1-15.9 billion). CONCLUSION: The cost of MOH around the period of a structured treatment protocol is much higher compared to previous estimates. Our protocol is cost-effective for reducing the economic burden of MOH.

The best from East and West? Acupuncture and medical training therapy as monotherapies or in combination for adult patients with episodic and chronic tension-type headache: study protocol for a randomized controlled trial.

BACKGROUND: This study aims to evaluate the feasibility and efficacy of a complex health intervention, based on the combination of conventional Western medicine and traditional Chinese medicine (TCM), in an outpatient department of a university hospital for patients with frequent episodic or chronic tension-type headaches. METHODS/DESIGN: This is a prospective randomized controlled pilot study with four balanced treatment arms (usual care, acupuncture, training, and training plus acupuncture). Each arm will have 24 patients. After the initial screening examination and randomization, a 6-week treatment period follows, with treatment frequencies decreasing at 2-week intervals. After completion of the intervention, two follow-up evaluations will be performed 3 and 6 months after the start of treatment. At predefined times, the various outcomes (pain intensity, health-related quality of life, pain duration, autonomic regulation, and heart rate variability) as well as the participants' acceptance of the complex treatment will be evaluated with valid assessment instruments (Migraine Disability Assessment, PHQ-D, GAD-7, and SF-12) and a headache diary. The acupuncture treatment will be based on the rules of TCM, comprising a standardized combination of acupuncture points and additional points selected according to individual pain localization. The training therapy comprises a combination of strength training, endurance training, and training to improve flexibility and coordination. Besides descriptive analyses of the samples, their comparability will be assessed using an analysis of variance (ANOVA) or chi-squared tests. Analyses will be performed on an intention-to-treat basis. Potential interaction effects will be calculated using a repeated-measures ANOVA to test the primary and secondary hypotheses. In supplementary analyses, the proportion of treatment responders (those with a 50% reduction in the frequency of pain episodes) will be determined for each treatment arm. DISCUSSION: This trial may provide evidence for the additive effects of acupuncture and medical training therapy as a combination treatment and may scientifically support the implementation of this complex health intervention. TRIAL REGISTRATION: Registered on 11 Feburary 2019. German Clinical Trials Register, DRKS00016723.

Comparison of chronic daily headache with and without medication overuse headache using ICHD II R and ICHD 3 beta criteria.

OBJECTIVE: To evaluate the frequency of Medication Overuse Headache (MOH) in the patients with Chronic Daily Headache (CDH) using International Classification of Headache Disorder II Revision (ICHD II R) and International Classification of Headache Disorder 3 Beta (ICHD-3 beta) criteria. We also compare the CHD patients with and without MOH using both the criteria. PATIENTS AND METHODS: Consecutive CDH patients from neurology service between 2014 and 2015 were included. The patients with CDH was categorised to MOH was based on ICHDIIR and ICHD-3 beta criteria. Their demographic and headache characteristics including frequency, duration, severity and disability were noted. Severity of headache was assessed using Visual Analogue Scale (VAS). Predictors of MOH were evaluated by multivariate analysis. Demographic and headache characteristics of CDH patients without MOH were compared with those with MOH. RESULTS: 202 patients were included whose median age was 32 (range 18-65) years, and 151(74.8%) were females. 12.3% patients fulfilled ICHDIIR criteria for MOH and 46.5% fulfilled ICHD-3 beta criteria. The predictors of MOH were female gender (OR = 3.72; 95% CI 1.72-8.02, p = 0.001), low education level (OR = 1.07, 95%CI 1.02-1.13; p = 0.007) and higher VAS score (OR = 0.67, 95%CI 0.51-0.88; p = 0.004). MOH patients as per ICHD-3 beta criteria had higher education (p = 0.02) and consumed lesser abortive drugs (p = 0.03) as compared with ICHDIIR criteria. CONCLUSION: The frequency of MOH increases by four-fold when using ICHD-3 beta criteria instead of ICHDIIR criteria. Females with lower education level predispose to MOH.

The CHESS trial: protocol for the process evaluation of a randomised trial of an education and self-management intervention for people with chronic headache.

BACKGROUND: Process evaluation is increasingly common alongside complex randomised controlled trials (RCTs). This evaluation helps in understanding the mechanisms of impact and how the study processes were executed, and it includes any contextual factors which may have implications for the trial results and any future implementation. This process evaluation is for the Chronic Headache Education and Self-management Study (CHESS) RCT, which is evaluating an education and self-management group behavioural intervention for people with chronic headache. Chronic headache is defined as headaches which are present for 15 or more days per month. The most common types are chronic migraine and chronic tension type and medication overuse headaches. METHODS: We will use a mixed methods approach. Quantitative data will be taken from routine trial data which will help us to assess the reach of the study; i.e. did we reach those whom we expected and from where? Intervention attendance (dose received) and attrition and qualitative data will augment our understanding about reasons why people may not wish to take part in or failed to attend sessions. Interviews with intervention facilitators and trial participants will gain different perspectives on taking part in the trial. Fidelity will be assessed through listening to audio recordings for adherence to course content and competence of the facilitation of a sample of sessions. DISCUSSION: Our process evaluation will allow us to gain insight into how the trial was delivered, the obstacles and enablers encountered and the possible reasons why the interventions may or may not be effective. TRIAL REGISTRATION: ISRCTN79708100 . Registered on 16 December 2015.