OBJECTIVE: To investigate the therapeutic effect of cranial microcurrent stimulation (CMS) in patients with tension-type headaches (TTH).
METHODS: This study was designed as a prospective, randomised, double-blinded and sham-controlled trial. A total of 22 patients with tension-type headache were selected as our study participants and randomly assigned into two groups: CMS group (n = 11) and Sham group (n = 11). To each of the participants, a sham or a true portable CMS stimulation device (CMS; intensity, 25 µA; frequency, 8 Hz) to wear was distributed, and 20-minute daily treatment was provided using the device for 2 weeks. In CMS group, treatment was given by means of electrodes clipped to the ear, whereas, in Sham group, sham treatment was provided by CMS without current. The measurements of Visual Analogue Scale (VAS), Headache Impact Test-6 (HIT6), Patient Health Questionnaire-9 (PHQ9), Generalised Anxiety Disorder 7-item (GAD7) and Hospital Anxiety and Depression Scale (HADS) were performed at pre-treatment (baseline), week 1 and 2 of treatment and two weeks post-treatment.
RESULTS: In CMS group, VAS of maximal headache and VAS of current headache, HIT6, PHQ9 and GAD7 significantly decreased by two weeks post-CMS therapy, but not in Sham group (P < .05). Scores of HADS-A (anxiety), HADS-D (depression) and HADS-T (total) significantly decreased by 2 weeks post-CMS therapy in CMS group, but not in Sham group (P < .05). Changes in scores of PHQ9 and GAD7, HADS-A, HADS-D and HADS-T in CMS group were significantly greater than in Sham group by 2 weeks post-CMS therapy (P < .05).
CONCLUSION: The results indicate that CMS, as an adjunctive treatment for patients with TTH, is safe and analgesic as well as reducing depression or anxiety.
This study may be considered only preliminary because of methodologic limitations, i.e. the limited sample size, and the blinding of patients not being verified.
This is a well-designed study with good sham control and adequate blinding.