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.

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).

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.

The working mechanism of manual therapy in participants with chronic tension-type headache.

STUDY DESIGN: Prospective longitudinal study. OBJECTIVE: To explore the working mechanism of manual therapy, we investigated whether 3 cervical spine variables were mediators of the effect of manual therapy on headache frequency. Background Manual therapy has been shown to reduce headache frequency in participants with chronic tension-type headache (CTTH). To what extent specific elements of treatment contribute to the effectiveness of manual therapy in CTTH is unknown. METHODS: One hundred eighty-two participants with CTTH participated in a prospective longitudinal study: 142 underwent manual therapy and 40 participants received usual care by their general practitioner. Regression analysis was performed according to the steps described by Baron and Kenny, and the proportion of mediated effect was estimated for 3 potential mediators: (1) cervical range of motion, (2) neck flexor endurance, and (3) forward head posture. Outcome was defined as a 50% or greater reduction in headache days. RESULTS: Neck flexor endurance mediated 24.5% of the effect of manual therapy. Cervical range of motion and forward head posture showed no mediated effect. CONCLUSIONS: Increased neck flexor endurance appears to be a working mechanism of manual therapy. This finding supports isometric training of neck flexors in participants with CTTH. Trial registered with Netherlands Trial Register (TR 1074).

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.

Clinical variables associated with recovery in patients with chronic tension-type headache after treatment with manual therapy.

The aims of this study were to describe the course of chronic tension-type headache (CTTH) in participants receiving manual therapy (MT), and to develop a prognostic model for predicting recovery in participants receiving MT. Outcomes in 145 adults with CTTH who received MT as participants in a previously published randomised clinical trial (n=41) or in a prospective cohort study (n=104) were evaluated. Assessments were made at baseline and at 8 and 26 weeks of follow-up. Recovery was defined as a 50% reduction in headache days in combination with a score of 'much improved' or 'very much improved' for global perceived improvement. Potential prognostic factors were analyzed by univariable and multivariable regression analysis. After 8 weeks 78% of the participants reported recovery after MT, and after 26 weeks the frequency of recovered participants was 73%. Prognostic factors related to recovery were co-existing migraine, absence of multiple-site pain, greater cervical range of motion and higher headache intensity. In participants classified as being likely to be recovered, the posterior probability for recovery at 8 weeks was 92%, whereas for those being classified at low probability of recovery this posterior probability was 61%. It is concluded that the course of CTTH is favourable in primary care patients receiving MT. The prognostic models provide additional information to improve prediction of outcome.

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.

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.