High concurrent validity between digital and analogue algometers to measure pressure pain thresholds in healthy participants and people with migraine: a cross-sectional study.

BACKGROUND: Pressure pain thresholds (PPTs) are commonly assessed to quantify mechanical sensitivity in various conditions, including migraine. Digital and analogue algometers are used, but the concurrent validity between these algometers is unknown. Therefore, we assessed the concurrent validity between a digital and analogue algometer to determine PPTs in healthy participants and people with migraine. METHODS: Twenty-six healthy participants and twenty-nine people with migraine participated in the study. PPTs were measured interictally and bilaterally at the cephalic region (temporal muscle, C1 paraspinal muscles, and trapezius muscle) and extra-cephalic region (extensor carpi radialis muscle and tibialis anterior muscle). PPTs were first determined with a digital algometer, followed by an analogue algometer. Intraclass correlation coefficients (ICC3.1) and limits of agreement were calculated to quantify concurrent validity. RESULTS: The concurrent validity between algometers in both groups was moderate to excellent (ICC3.1 ranged from 0.82 to 0.99, with 95%CI: 0.65 to 0.99). Although PPTs measured with the analogue algometer were higher at most locations in both groups (p < 0.05), the mean differences between both devices were less than 18.3 kPa. The variation in methods, such as a hand-held switch (digital algometer) versus verbal commands (analogue algometer) to indicate when the threshold was reached, may explain these differences in scores. The limits of agreement varied per location and between healthy participants and people with migraine. CONCLUSION: The concurrent validity between the digital and analogue algometer is excellent in healthy participants and moderate in people with migraine. Both types of algometer are well-suited for research and clinical practice but are not exchangeable within a study or patient follow-up.

Fluctuations in local and widespread mechanical sensitivity throughout the migraine cycle: a prospective longitudinal study.

BACKGROUND: People with migraine have localised (i.e., cephalic) mechanical sensitivity. There is uncertainty regarding widespread (i.e., extra-cephalic) mechanical sensitivity and variations in mechanical sensitivity throughout the migraine cycle. Therefore, this study aimed (1) to comprehensively assess mechanical sensitivity in both cephalic and extra-cephalic regions during the preictal, ictal, postictal and interictal phases; and (2) to compare these findings with mechanical sensitivity at corresponding time-points and locations in healthy participants. METHODS: According to sample size calculations, 19 people with migraine and 19 matched healthy volunteers participated in a prospective longitudinal study. Pressure pain thresholds were evaluated in three cephalic regions (temporalis, upper trapezius and C1 paraspinal muscles) and two extra-cephalic regions (extensor carpi radialis and tibialis anterior muscle) with a digital algometer during the four phases of the migraine cycle in people with migraine and at corresponding intervals and locations in healthy participants. Linear mixed model analyses with a random intercept were used. RESULTS: People with migraine had increased mechanical sensitivity in cephalic and extra-cephalic regions in all phases of the migraine cycle compared to healthy participants. Furthermore, this mechanical sensitivity was more severe in the preictal, ictal and postictal phase compared to the interictal phase in cephalic and extra-cephalic regions. CONCLUSION: People with migraine have localised as well as widespread mechanical sensitivity compared to healthy participants. This sensitivity is even more pronounced immediately before, during and after a migraine attack.

The effect of aerobic exercise on the number of migraine days, duration and pain intensity in migraine: a systematic literature review and meta-analysis.

BACKGROUND: In patients with frequent migraine, prophylactic treatments are used. Patients often request non-pharmacological alternatives. One treatment option can be aerobic exercise. The value of aerobic exercise as prophylactic treatment however needs to be determined. METHODS: A systematic review and meta-analysis was performed to investigate the result of aerobic exercise on the number of migraine days, duration and pain intensity in patients with migraine. After screening three online databases, PubMed, Cochrane library and Web of Science, using predefined in- and exclusion criteria, six studies were retained. Pooling of data was performed when possible. RESULTS: Significant reductions in the number of migraine days after aerobic exercise treatment were found with a mean reduction of 0.6 ± 0.3 migraine days/month. Other outcomes were too variable to pool due to heterogeneity of outcome measurements. Unpooled data revealed small to moderate reductions in attack duration (20-27%) and pain intensity (20-54%) after aerobic exercise intervention. Various exercise intensities are applied. CONCLUSION: There is moderate quality evidence that in patients with migraine aerobic exercise therapy can decrease the number of migraine days. No conclusion for pain intensity or duration of attacks can be drawn. Effect sizes are small due to a lack of uniformity. For future studies, we recommend standardized outcome measures and sufficiently intense training programs. TRIAL REGISTRATION: CRD42018091178 .

Pressure pain thresholds over the cranio-cervical region in headache: a systematic review and meta-analysis.

BACKGROUND: Sensitivity of tissues can be measured by algometry. Decreased pressure pain thresholds over the cranio-cervical area are supposed to reflect signs of sensitization of the trigemino-cervical nucleus caudalis. A systematic review was conducted to assess the current scientific literature describing pressure pain threshold (PPT) values over the cranio-cervical region in patients with migraine, tension-type headache (TTH), and cervicogenic headache (CeH). A literature search was executed in three databases. The search strategy included the following keywords: migraine, TTH, CeH, PPT and algometry. A total of 624 papers was identified of which relevant papers were subsequently assessed for methodological quality. Twenty-two selected papers were assessed by two independent reviewers and the majority of studies scored low risk of bias on the selected items. Mean PPT values of several sites measured in the cranio-cervical region in patients with migraine, chronic TTH and CeH scored lower values compared to controls. The trapezius muscle (midpoint between vertebrae C7 and acromion) was the most frequently targeted site and showed significantly lower PPT values in adults with migraine (pooled standardized mean difference kPa: 1.26 [95%CI -1.71, -0.81]) and chronic TTH (pooled standardized mean difference kPa: -2.00 [95%CI -2.93, -1.08]). Most studies found no association between PPT values and headache characteristics such as frequency, duration or intensity. Further standardization of PPT measurement in the cranio-cervical region is recommended.

Translating the new International IFOMPT Cervical Framework into a framework flowchart for clinical practice and education.

BACKGROUND: In 2020, a revised version of the International IFOMPT Cervical Framework was published. This framework provides both physical therapists and educators the necessary information to guide the assessment of the cervical spine region for potential vascular pathologies of the neck in advance of planned Orthopaedic Manual Therapy (OMT) interventions. OBJECTIVE: The objective was to develop a framework flowchart which is useful in clinical practice and education to assist physical therapists to improve the safety of OMT, and apply this in a case report. METHODS: The framework was developed in co-creation with manual therapy experts, researchers, educators in manual therapy, patients, medical specialists and the Manual Therapy Association in The Netherlands and Belgium. Manual therapists and patients tested the framework for intelligibility and usefulness. RESULTS: A framework flowchart is developed and presented, that is easy to use in both clinical practice and education. It is a visual representation of the sequence of steps and decisions needed during the process. A case description of a patient with neck pain and headache is added to illustrate the clinical usefulness of the framework flowchart. CONCLUSION: The framework flowchart helps physical therapists in their clinical reasoning to provide safe OMT interventions.

Risk assessment of vascular complications following manual therapy and exercise for the cervical region: diagnostic accuracy of the International Federation of Orthopaedic Manipulative Physical Therapists framework (The Go4Safe project).

QUESTION: What is the diagnostic accuracy of the International Federation of Orthopaedic Manipulative Physical Therapists (IFOMPT) framework to assess the risk of vascular complications in patients seeking physiotherapy care for neck pain and/or headache? DESIGN: Cross-sectional diagnostic accuracy study. PARTICIPANTS: One hundred and fifty patients seeking physiotherapy for neck pain and/or headache in primary care. METHODS: Nineteen physiotherapists performed the index test according to the IFOMPT framework. Patients were classified as having a high, intermediate or low risk of vascular complications, following manual therapy and/or exercise, derived from the estimated risk of the presence of vascular pathology. The reference test was a consensus medical decision reached by a vascular neurologist and an interventional neurologist, with input from a neuroradiologist. The neurologists had access to clinical data and magnetic resonance imaging of the cervical spine, including an angiogram of the cervical arteries. OUTCOME MEASURES: Diagnostic accuracy measures were calculated for 'no contraindication' (ie, the low-risk category) and 'contraindication' (ie, the high-risk and intermediate-risk categories) for manual therapy and/or exercise. Sensitivity, specificity, predictive values, likelihood ratios and the area under the curve were calculated. RESULTS: Manual therapy and/or exercise were contraindicated in 54.7% of the patients. The sensitivity of the IFOMPT framework was low (0.50, 95% CI 0.39 to 0.61) and its specificity was moderate (0.63, 95% CI 0.51 to 0.75). The positive and negative likelihood ratios were weak at 1.36 (95% CI 0.93 to 1.99) and 0.79 (95% CI 0.60 to 1.05), respectively. The area under the curve was poor (0.57, 95% CI 0.49 to 0.65). CONCLUSION: The IFOMPT framework has poor diagnostic accuracy when compared with a reference standard consisting of a consensus medical decision.

Study protocol for a nationwide implementation of internet-based vestibular rehabilitation for patients with chronic vestibular symptoms (I-RECOVER).

BACKGROUND: Vestibular rehabilitation is a safe and effective exercise-based treatment for patients with chronic vestibular symptoms. However, it is underused in general practice. Internet-based vestibular rehabilitation (Vertigo Training), which has proven to be effective as well, was developed to increase uptake. We now aim to improve the quality of care for patients with vestibular symptoms by carrying out a nationwide implementation of Vertigo Training. We will evaluate the effect of this implementation on primary care. METHODS: Our implementation study consists of three successive phases: 1) We will perform a retrospective observational cohort study and a qualitative interview study to evaluate the current management of patients with vestibular symptoms in primary care, in particular anti-vertigo drug prescriptions, and identify areas for improvement. We will use the results of this phase to tailor our implementation strategy to the needs of general practitioners (GPs) and patients. 2) This phase entails the implementation of Vertigo Training using a multicomponent implementation strategy, containing: guideline adaptations; marketing strategy; pharmacotherapeutic audit and feedback meetings; education; clinical decision support; and local champions. 3) In this phase, we will evaluate the effect of the implementation in three ways. a. Interrupted time series. We will use routine primary care data from adult patients with vestibular symptoms to compare the number of GP consultations for vestibular symptoms, referrals for vestibular rehabilitation, prescriptions for anti-vertigo drugs, and referrals to physiotherapy and secondary care before and after implementation. b. Prospective observational cohort study. We will extract data from Vertigo Training to investigate the usage and the characteristics of participants. We will also determine whether these characteristics are associated with successful treatment. c. Qualitative interview study. We will conduct interviews with GPs to explore their experiences with the implementation. DISCUSSION: This is one of the first studies to evaluate the effect of a nationwide implementation of an innovative treatment on Dutch primary care. Implementation strategies have been researched before, but it remains unclear which ones are the most effective and under what conditions. We therefore expect to gain relevant insights for future projects that aim to implement innovations in primary care.

Minimal clinically important change on the Headache Impact Test-6 questionnaire in patients with chronic tension-type headache.

OBJECTIVE: To determine the minimal clinically important change (MCIC) in Headache Impact Test-6 (HIT-6) score in patients with chronic tension-type headache (CTTH). METHODS: The HIT-6 was administered at baseline and at 8 weeks follow-up in a cohort of 186 participants with CTTH who received manual therapy or usual care by their general practitioner. An anchor-based method was used to determine the MCIC, with the external criterion (anchor) being based on general perceived improvement ('much improved or very much improved' on a 7-point Likert scale) in combination with 50% reduction in headache days. Using receiver operating characteristic (ROC) curve analysis we defined an optimal cut-off score discriminating between improved and not improved participants. RESULTS: The optimal cut-off point for the MCIC for the HIT-6 was -8 points, on a total scale range of 42 points. CONCLUSION: A clinically relevant improvement in patients with CTTH is reflected by a decrease of at least 8 points on the HIT-6.

Modulation of Central Nociceptive Transmission by Manual Pressure Techniques in Patients with Migraine: An Observational Study.

Background: Manual pressure in the upper cervical spine is used to provoke and reduce the familiar migraine headache. Information is scarce on the segmental levels, myofascial structure provocation, and reduction occurrences. The required dosage (amount of pressure, number of repetitions, and duration) has not been objectified yet. Methods: Prospective observational study. Thirty patients with migraine were examined interictally. Manual pressure was applied at four sites: the posterior arch of C1, the articular pillar of C2, the rectus capitis posterior major muscle, and the obliquus capitis inferior muscle, bilaterally. On sites where the familiar headache was provoked, the pressure was sustained to induce pain reduction (three repetitions). Provocation of familiar headache (yes/no), headache intensity (numerical pain rating scale), time to obtain a reduction of the headache (seconds), and applied pressure (g/cm2) were recorded. Results: Provocation of the familiar headache occurred at the posterior arches C1 in 92%, and at one of the articular pillars of C2 in 65.3% of cases. At one of the rectus capitis major muscles, the familiar headache was provoked in 84.6% of cases; at one of the oblique capitis inferior muscles, the familiar headache was provoked in 76.9% of cases. The applied mean pressure ranged from 0.82 to 1.2 kg/cm2. Maintaining the pressure reduced headache pain intensity significantly between the start and end of each of the three consecutive trials (p < 0.04). This reduction occurred faster in the third application than in the first application (p = 0.03). Conclusion: Manual pressure at upper cervical segments provokes familiar referred migraine headaches, with low manual pressure. Maintaining the pressure reduces the referred head pain significantly, indicating modulation of central nociceptive transmission.

Outcome for dizzy patients in a physiotherapy practice: an observational study.

BACKGROUND: Dizziness is a common reason for referral to physiotherapy. Additional information on clinical characteristics, treatment effect and prognostic indicators in physiotherapy practice are needed. METHODS: A retrospective observational study. Based on a standardised clinical evaluation patients were labelled as having Benign Paroxysmal Positioning Vertigo (BPPV) or not (no-BPPV). BPPV was treated with repositioning manoeuvres and exercises. In no-BPPV, treatment was based on additional clinical tests. Treatment was provided once per week and considered successful when the patient was free of symptoms confirmed by negative positional tests. RESULTS: From 148 referred patients, 88 were labelled as having BPPV, 60 as no-BPPV. The symptom of a short-lasting spinning sensation provoked by head movements was highly suggestive of BPPV. On average, in BPPV treatment was completed after 2.27 ± 1.68 treatments, in no-BPPV this was after 4.91 ± 3.46 treatments. The delayed outcome was related to higher 'age' and 'concomitant neck pain' in BPPV and with higher 'age' only in no-BPPV. Favourable outcome was related to the feature 'dizziness provoked by movements in the horizontal plane' in BPPV. CONCLUSIONS: Clinical evaluation and treatment in physiotherapy practice can be an effective and safe option for patients with dizziness. Several clinical variables with prognostic values were identified.Key messagesClinical evaluation and treatment in physiotherapy practice can be part of low threshold care for dizzy patients.Despite prior medical screening, one-third of patients without signs of BPPV were sent back for further evaluation, illustrating the need for interdisciplinary collaboration.Based on the description of the dizziness symptom (vertigo rather than light-headedness), provocation of the dizziness by movements, and a short duration of the dizziness attack, and positive clinical vestibular tests, BPPV treatment could be initiated.

Effectiveness of manual therapy for chronic tension-type headache: a pragmatic, randomised, clinical trial.

OBJECTIVE: To evaluate the effectiveness of manual therapy (MT) in participants with chronic tension-type headache (CTTH). SUBJECTS AND METHODS: We conducted a multicentre, pragmatic, randomised, clinical trial with partly blinded outcome assessment. Eighty-two participants with CTTH were randomly assigned to MT or to usual care by the general practitioner (GP). Primary outcome measures were frequency of headache and use of medication. Secondary outcome measures were severity of headache, disability and cervical function. RESULTS: After 8 weeks (n = 80) and 26 weeks (n = 75), a significantly larger reduction of headache frequency was found for the MT group (mean difference at 8 weeks, -6.4 days; 95% CI -8.3 to -4.5; effect size, 1.6). Disability and cervical function showed significant differences in favour of the MT group at 8 weeks but were not significantly different at 26 weeks. CONCLUSIONS: Manual therapy is more effective than usual GP care in the short- and longer term in reducing symptoms of CTTH. Dutch Trial Registration no. TR 1074.

Pericranial Total Tenderness Score in Patients with Tension-type Headache and Migraine. A Systematic Review and Meta-analysis.

BACKGROUND: Increased pericranial tenderness is considered to be a typical characteristic of tension-type headache (TTH). Assessment of pericranial tenderness in TTH using the total tenderness score is recommended by the International Classification of Headache Disorders-3 (ICHD-3). However, to what extent pericranial tenderness differs between patients with TTH or migraine and healthy patients is unknown. OBJECTIVE: To assess the presence and differences in total tenderness score between patients with TTH or migraine, and healthy patients. STUDY DESIGN: Systematic review and meta-analysis. METHODS: A literature search was performed in Pubmed/MEDLINE, EMBASE, CINAHL, and Google Scholar databases from inception to August 14, 2020 and identified 4,197 hits. Two independent reviewers selected the studies, extracted data, and performed a risk of bias assessment according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Overall evidence was assessed according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. From the 185 papers identified, 15 case-control and 2 cross-sectional studies were included. RESULTS: In total 1,200 (327 men, 873 women) patients with TTH or migraine were included in the systematic review. In the meta-analysis, 15 studies were analyzed and showed that the total tenderness score is higher in people with episodic TTH (standardized mean difference [SMD] 0.91; 95% confidence interval [CI]: 0.63 to 1.19), chronic TTH (SMD 1.57; 95% CI 1.24 to 1.91) and migraine (SMD 1.27; 95% CI: 0.91to 1.63) compared to healthy patients. LIMITATIONS: The description and performance of the total tenderness score differed across the studies. In 7 studies, patients were included with coexisting types of headache. CONCLUSION: We found moderate quality evidence for higher tenderness in chronic TTH and migraine, and low quality evidence for higher tenderness in episodic TTH compared to healthy patients. Pericranial tenderness is a common finding in patients with headache and healthy patients. These findings apply for a critical evaluation of the total tenderness score in the current ICHD-3 classification of TTH.

Interexaminer Agreement and Reliability of an Internationally Endorsed Screening Framework for Cervical Vascular Risks Following Manual Therapy and Exercise: The Go4Safe Project.

OBJECTIVE: Clinicians are recommended to use the clinical reasoning framework developed by the International Federation of Orthopaedic Manipulative Physical Therapists (IFOMPT) to provide guidance regarding assessment of the cervical spine and potential for cervical artery dysfunction prior to manual therapy and exercise. However, the interexaminer agreement and reliability of this framework is unknown. This study aimed to estimate the interexaminer agreement and reliability of the IFOMPT framework among physical therapists in primary care. METHODS: Ninety-six patients who consulted a physical therapist for neck pain or headache were included in the study. Each patient was tested independently by 2 physical therapists, from a group of 17 physical therapists (10 pairs) across The Netherlands. Patients and examiners were blinded to the test results. The overall interexaminer agreement, specific agreement per risk category (high-, intermediate-, and low-risk), and interexaminer reliability (weighted κ) were calculated. RESULTS: Overall agreement was 71% (specific agreement in high-risk category = 63%; specific agreement in intermediate-risk category = 38%; specific agreement in low-risk category = 84%). Overall reliability was moderate (weighted κ = 0.39; 95% CI = 0.21-0.57) and varied considerably between pairs of physical therapists (κ = 0.14-1.00). CONCLUSION: The IFOMPT framework showed an insufficient interexaminer agreement and fair interexaminer reliability among physical therapists when screening the increased risks for vascular complications following manual therapy and exercise prior to treatment. IMPACT: The IFOMPT framework contributes to the safety of manual therapy and exercise. It is widely adopted in clinical practice and educational programs, but the measurement properties are unknown. This project describes the agreement and reliability of the IFOMPT framework.

Outcome measures for assessing the effectiveness of non-pharmacological interventions in frequent episodic or chronic migraine: a Delphi study.

OBJECTIVES: The aim of this Delphi survey was to establish an international consensus on the most useful outcome measures for research on the effectiveness of non-pharmacological interventions for migraine. This is important, since guidelines for pharmacological trials recommend measuring the frequency of headaches with 50% reduction considered a clinically meaningful effect. It is unclear whether the same recommendations apply to complementary (or adjunct) non-pharmacological approaches, whether the same cut-off levels need to be considered for effectiveness when used as an adjunct or stand-alone intervention, and what is meaningful to patients. SETTING: University-initiated international survey. PARTICIPANTS: The expert panel was chosen based on publications on non-pharmacological interventions in migraine populations and from personal contacts. 35 eligible researchers were contacted, 12 agreed to participate and 10 completed all 3 rounds of the survey. To further explore how migraine patients viewed potential outcome measures, four migraine patients were interviewed and presented with the same measurement tools as the researchers. PROCEDURES: The initial Delphi round was based on a systematic search of the literature for outcome measures used in non-pharmacological interventions for headache. Suggested outcome measures were rated by each expert, blinded towards the other members of the panel, for its usefulness on a 5-point Likert scale ranging from definitely not useful to extremely useful. Results were combined using median values and IQRs. Tools rated overall as definitely or probably not useful were excluded from subsequent rounds. Experts further suggested additional outcome measures that were presented to the panel in subsequent rounds. Additionally, experts were asked to rank the most useful tools and provide information on feasible cut-off levels for effectiveness for the three highest ranked tools. RESULTS: Results suggest the use of the Migraine Disability Assessment (MIDAS), Headache Impact Test (HIT-6) and headache frequency as primary outcome measures. Patient experts suggested the inclusion of a measure of quality of life and evaluation of associated symptoms and fear of attacks. CONCLUSIONS: Recommendations are for the use of the MIDAS, the HIT-6 and headache frequency, in combination with an outcome measure for quality of life. Associated symptoms and fear of attacks should also be considered as secondary outcomes, if relevant for the individual target population. The cut-off level for effectiveness should be lower for non-pharmacological interventions, especially when used as an adjunct to medication. TRIAL REGISTRATION NUMBER: German Register of Clinical Trials (DRKS00011777).

Effectiveness of manual therapy compared to usual care by the general practitioner for chronic tension-type headache: design of a randomised clinical trial.

BACKGROUND: Patients with Chronic Tension Type Headache (CTTH) report functional and emotional impairments (loss of workdays, sleep disturbances, emotional well-being) and are at risk for overuse of medication. Manual therapy may improve symptoms through mobilisation of the spine, correction of posture, and training of cervical muscles.We present the design of a randomised clinical trial (RCT) evaluating the effectiveness of manual therapy (MT) compared to usual care by the general practitioner (GP) in patients with CTTH. METHODS AND DESIGN: Patients are eligible for participation if they present in general practice with CTTH according to the classification of the International Headache Society (IHS).Participants are randomised to either usual GP care according to the national Dutch general practice guidelines for headache, or manual therapy, consisting of mobilisations (high- and low velocity techniques), exercise therapy for the cervical and thoracic spine and postural correction. The primary outcome measures are the number of headache days and use of medication. Secondary outcome measures are severity of headache, functional status, sickness absence, use of other healthcare resources, active cervical range of motion, algometry, endurance of the neckflexor muscles and head posture. Follow-up assessments are conducted after 8 and 26 weeks. DISCUSSION: This is a pragmatic trial in which interventions are offered as they are carried out in everyday practice. This increases generalisability of results, but blinding of patients, GPs and therapists is not possible.The results of this trial will contribute to clinical decision making of the GP regarding referral to manual therapy in patients with chronic tension headache.

A Neuroscience Perspective of Physical Treatment of Headache and Neck Pain.

The most prevalent primary headaches tension-type headache and migraine are frequently associated with neck pain. A wide variety of treatment options is available for people with headache and neck pain. Some of these interventions are recommended in guidelines on headache: self-management strategies, pharmacological and non-pharmacological interventions. Physical treatment is a frequently applied treatment for headache. Although this treatment for headache is predominantly targeted on the cervical spine, the neurophysiological background of this intervention remains unclear. Recent knowledge from neuroscience will enhance clinical reasoning in physical treatment of headache. Therefore, we summarize the neuro- anatomical and-physiological findings on headache and neck pain from experimental research in both animals and humans. Several neurophysiological models (referred pain, central sensitization) are proposed to understand the co-occurrence of headache and neck pain. This information can be of added value in understanding the use of physical treatment as a treatment option for patients with headache and neck pain.

Manual therapy as a prophylactic treatment for migraine: design of a randomized controlled trial.

BACKGROUND: People with migraine often experience disability with serious consequences for their social life and work productivity. The pharmacological prophylactic management of migraine is effective in reducing migraine attacks. However, many people are reluctant to use daily prophylactic medication, leading to a demand for non-pharmacological treatment options. We present the design for and discuss the feasibility of a pragmatic, randomized controlled trial on the effectiveness of a multimodal manual therapy (MT) treatment compared to usual care by the general practitioner (GP) for the prophylactic treatment of migraine. METHODS: Eligible participants will be recruited in primary care using the International Classification of Headache Disorders III criteria for migraine of the International Headache Society. Participants will be randomized to either multimodal MT treatment or usual care provided by the GP. GPs will be asked to treat the usual care group according to the Dutch GP guideline for headache. The multimodal MT intervention will include manual pressure techniques, neck muscle-strength exercises and mobilization of the cervical and thoracic spine. The trial will consist of a 12-week treatment period and follow-up measurements at 12, 26 and 52 weeks. The primary outcome measure is the number of migraine days per 4 weeks, assessed with a headache diary. Secondary outcome measures are the number of migraine attacks, medication use, disability due to headache, headache intensity, number of participants reporting a 50% migraine reduction, measurement of cervical pressure pain thresholds, presence of allodynia, endurance of cervical flexor muscles, days of absence of work and global perceived effect. DISCUSSION: The results of the trial will show whether a multimodal MT intervention is an effective non-pharmacological treatment option for people with migraine. TRIAL REGISTRATION: Dutch Trial Register, NL7504. Registered on 7 February 2019.