A randomized controlled trial on combining therapeutic patient education with standard care versus standard care alone for chronic migraine: Effects on patient-reported outcome measures

Background Therapeutic patient education (TPE) has been understudied for the management of chronic migraine (CM). Objective To study the effects of TPE with standard of care (SOC) versus SOC alone on patient-related outcome measures (PROM) in CM. Methods CM patients who were not on any preventive drugs for the past 3 months, aged 18–65 years, were randomized to receive TPE with SOC versus SOC alone and followed up for 12 weeks. TPE was imparted by a medical student following a rigorous 4-week training program by two senior headache specialists. TPE was imparted in the form of interactive group sessions lasting at least 20 minutes every 2 weeks. Patients in the control group received only SOC and instructions on dosing. The primary endpoint was the change in the Migraine-Specific Quality of Life (MSQOL) scores at Week 12. The key secondary outcomes were changes in the Headache Impact Test-6 (HIT-6) and Migraine Disability Assessment (MIDAS) scores at Week 12. Other secondary endpoints were also assessed. Efficacy analyses were performed in a modified intention-to-treat population who had at least one follow-up visit at Week 4. The trial was registered with the Clinical Trial Registry of India (CTRI/2022/06/04361). Results One hundred twenty-six patients were randomized. One hundred and seventeen patients (57 in the treatment and 60 in the control group) were available for the final efficacy analysis. The treatment group, compared with the control, showed a significant improvement from baseline to Week 12 in primary and key secondary endpoints. The mean change in MSQOL score was −11 (95% CI: −15.8 to −6.1); p -value < 0.001; HIT-6 scores, −6.4 (95% CI: −9.4 to −3.3); p -value < 0.001, and MIDAS scores −8.9 (95% CI: −17.2 to −0.6); p -value = 0.04, favoring the treatment group. Other secondary endpoints also showed superior outcomes for the treatment group. Conclusion TPE as an adjunct to SOC improved migraine-specific quality of life and headache-related disability in patients with CM. Trial Registration: Clinical Trial Registry of India (CTRI/2022/06/04361).