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).

Neck/shoulder function in tension-type headache patients and the effect of strength training.

INTRODUCTION: Muscle pain has been associated with reduced maximal muscle strength, and reduced rate of force development (RFD). Strength training (ST) has shown an effect in not only normalizing muscle function but also reducing neck muscle pain. AIM: The aims of this study were to compare muscle function in terms of strength, force steadiness in neck flexion, as well as extension, and rate of RFD of the shoulder in tension-type headache (TTH) patients and healthy controls and to examine the correlation to tenderness. Furthermore, the aim of the study was to examine the effect of ST on neck and shoulder functions in TTH patients. PARTICIPANTS AND METHODS: In all, 60 TTH patients and 30 sex- and age-matched healthy controls were included for a case-control comparison. The 60 patients with TTH were randomized into an ST and an ergonomic and posture correction (EP) control group. The ST group trained for 10 weeks with elastic bands. RESULTS: TTH patients had a lower extension force steadiness with a significant 15% higher coefficient of variation (CoV) compared to healthy controls (p=0.047). A significantly lower RFD (25%) was noted in the TTH group than in the healthy controls (p=0.031). A significant (p<0.01) and moderate correlation to muscle tenderness was found. In the intervention, 23 patients completed ST and 21 patients completed EP. No significant between-group effect was observed, but at 22 weeks follow-up, both groups had a significant within-group effect of improved extension force steadiness (ST: p=0.011 and EP: p<0.01). CONCLUSION: TTH patients showed a deteriorated muscle function, indicated by a lower force steadiness and RFD, compared to the healthy controls. The effect of ST was not larger than EP as both groups of TTH patients showed some improvement in neck and shoulder functions during the 10 weeks intervention and at follow-up. Future interventions are needed to elucidate if normalization of muscle function can lead to a reduction in headache.

Efficacy of strength training on tension-type headache: A randomised controlled study.

Background Strength training has shown effects in reducing neck pain. As neck pain is highly prevalent in tension-type headache (TTH), it is relevant to examine the effect of strength training of the shoulder muscles on TTH patients. Aim To examine the effect of strength training of the shoulder/neck muscles on TTH frequency and duration. Methods Sixty patients with TTH were randomised into strength training or a control group. The strength training group trained ten weeks with elastic resistance bands. The control group performed ergonomic and posture correction. Efficacy was evaluated at follow-up after 19-22 weeks. Results Twenty-three patients completed strength training and 21 completed ergonomic and posture correction (per-protocol). No between-group effect was detected, but within groups numerical reductions were noted in both groups from baseline to follow-up. Frequency of TTH in the strength training group decreased by 11% ( P = 0.041) and duration decreased by10% ( P = 0.036), while the ergonomic and posture correction group showed a significant reduction in frequency of 24% ( P = 0.0033) and a decrease in duration of 27% ( P = 0.041). Conclusion No significant difference between the groups was found and the within-group effects did not reach clinical significance. Combining all the elements into a multifaceted intervention could prove more useful and should be further explored in future studies. Clinical trials registration number NCT02984826.

Specific strength training compared with interdisciplinary counseling for girls with tension-type headache: a randomized controlled trial.

BACKGROUND: Childhood tension-type headache (TTH) is a prevalent and debilitating condition for the child and family. Low-cost nonpharmacological treatments are usually the first choice of professionals and parents. This study examined the outcomes of specific strength training for girls with TTH. METHODS: Forty-nine girls aged 9-18 years with TTH were randomized to patient education programs with 10 weeks of strength training and compared with those who were counseled by a nurse and physical therapist. Primary outcomes were headache frequency, intensity, and duration; secondary outcomes were neck-shoulder muscle strength, aerobic power, and pericranial tenderness, measured at baseline, after 10 weeks intervention, and at 12 weeks follow-up. Health-related quality of life (HRQOL) questionnaires were assessed at baseline and after 24 months. RESULTS: For both groups, headache frequency decreased significantly, P=0.001, as did duration, P=0.022, with no significant between-group differences. The odds of having headache on a random day decreased over the 22 weeks by 0.65 (0.50-0.84) (odds ratio [95% confidence interval]). For both groups, neck extension strength decreased significantly with a decrease in cervicothoracic extension/flexion ratio to 1.7, indicating a positive change in muscle balance. In the training group, shoulder strength increased $10% in 5/20 girls and predicted [Formula: see text] increased $15% for 4/20 girls. In the training group, 50% of girls with a headache reduction of $30% had an increase in [Formula: see text] >5%. For the counseling group, this was the case for 29%. A 24-month follow-up on HRQOL for the pooled sample revealed statistically significant improvements. Fifty-five percent of the girls reported little to none disability. CONCLUSION: The results indicate that both physical health and HRQOL can be influenced significantly by physical exercise and nurse counseling. More research is needed to examine the relationship between physical exercise, [Formula: see text], and TTH in girls. Thus, empowering patient education to promote maximum possible outcomes for all children needs more attention.

Neck and shoulder muscle strength in patients with tension-type headache: A case-control study.

INTRODUCTION: Tension-type headache (TTH) is highly prevalent in the general population, and it is characterized by increased muscle tenderness with increasing headache frequency and intensity. AIM: The aim of this case-control study was to compare muscle strength in neck and shoulder muscles in TTH patients and healthy controls by examining maximal voluntary isometric contraction (MVC) during shoulder abduction, neck flexion and extension as well as the extension/flexion strength ratio of the neck. METHODS: Sixty TTH patients and 30 sex- and age-matched healthy controls were included. Patients were included if they had TTH ≥8 days per month. The MVC neck extensor and flexor muscles were tested with the participant seated upright. MVC shoulder abduction was tested with the individual lying supine. RESULTS: Compared to controls TTH patients had significantly weaker muscle strength in neck extension (p = 0.02), resulting in a significantly lower extension/flexion moment ratio (p = 0.03). TTH patients also showed a tendency toward significantly lower muscle strength in shoulder abduction (p = 0.05). Among the 60 TTH patients, 25 had frequent episodic TTH (FETTH), and 35 had chronic TTH (CTTH). CONCLUSION: Patients with TTH exhibited decreased muscle strength in the neck extensor muscles, inducing a reduced cervical extension/flexion ratio compared to healthy people.