Multicenter, double-blind, and randomized controlled trial of Ultra-Distal Transcutaneous Electrical Nerve Stimulation (TENS) Device for Migraine treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
206
When subjects report experiencing or impending headache episodes, complete the VAS assessment and immediately administer transcutaneous electrical stimulation (TENS) therapy in the treatment area. Prior to activating the TENS wristband, first initiate EEG recording and maintain 5 minutes of rest. Subsequently, activate the TENS wristband for neuromodulation therapy while continuing rest and recording. After headache subsides, repeat the VAS assessment and maintain rest for 5 minutes before concluding. A safety follow-up (telephone consultation or online questionnaire) should be completed one week after the treatment session.
When subjects experience or anticipate headache onset, complete the VAS assessment and immediately administer transcutaneous electrical stimulation (TENS) in a non-treatment area. Before activating the TENS wristband, first initiate EEG recording and maintain 5 minutes of rest. Then activate the TENS wristband for neuromodulation therapy while continuing rest and recording. After headache subsides, repeat the VAS assessment and maintain rest for 5 minutes before concluding. Complete a safety follow-up one week after the same-day treatment (via telephone consultation or online questionnaire).
Electrical stimulator
Hangzhou, Zhejiang, China
Reduce the intensity of migraine
After treatment, participants rated their headache intensity as 0 (no pain =0 points, mild =1 point, moderate =2 points, severe =3 points).
Time frame: Baseline and 2 hours post-treatment
the pre-selected accompanying symptoms
Participants no longer experienced the pre-selected accompanying symptoms (e.g., nausea, vomiting, photophobia, phonophobia) after 2 hours of treatment.
Time frame: Baseline and 2 hours post-treatment
pain relief
Pain relief measured by Visual Analogue Scale (VAS)：Number of participants transitioning from moderate to mild pain at 2 hours post-treatment.
Time frame: Baseline and 2 hours post-treatment
returned to normal function
Number of participants who resumed normal daily activities (e.g., ability to ambulate freely or return to work/school) by 2 hours post-treatment.
Time frame: Baseline and 2 hours post-treatment
Use of acute treatment drugs
Use of acute treatment drugs within 24 hours of treatment
Time frame: Baseline and 24 hours post-treatment
recurrence of migraine
No recurrence of migraine attack occurred within 2-24 hours after treatment
Time frame: Baseline and 2-24 hours post-treatment
recurrence of migraine2
No recurrence of migraine attack occurred within 2-48 hours after treatment
Time frame: Baseline and 2-48 hours post-treatment
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pain-free status
Participants achieved pain-free status (VAS score 0) at 15,30,45,60, and 90 minutes post-treatment, having progressed from moderate to severe pain.
Time frame: Baseline and 15,30,45,60, and 90 minutes post-treatment
symptoms free
Participants' accompanying symptoms (e.g., nausea, vomiting, photophobia, phonophobia) did not reappear at 15,30,45,60, and 90 minutes after treatment
Time frame: Baseline and 15,30,45,60, and 90 minutes post-treatment