Is pain relief from acupuncture reflected in the flow of blood-oxygen in the brain and muscles of migraine patients?

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2017
INTERVENTION: Participants are randomly allocated to one of the three groups below: 1. Verum acupuncture (de‐qi‐inducing needling at specified points) 2. Placebo acupuncture (shallow needle stimulation a specified distance away from specified points, no induction of de qi) 3. No acupuncture (patients receive no acupuncture in the study period) In all arms, patients have access to medication prescribed prior to, including rescue medicine for headache. Acupuncture (verum or placebo) is administered three times a week for four weeks, with sessions lasting 30 minutes each. Blood flow in the brain are compared for groups 2 and 3 using near‐infrared spectroscopy. CONDITION: Migraine (with or without aura) ; Nervous System Diseases ; Migraine (with or without aura) PRIMARY OUTCOME: Primary clinical measures: ; 1. Headache duration (headache hours/day); 2. Headache frequency (headache days/month) 3. Headache intensity (VAS score) ; ; These are recorded in headache diaries covering the 12‐week duration of the study and apply to all treatment arms; ; Primary hemodynamic measures: ; 1. Regional oxygenation of the cerebral cortex (Oxy/Deoxy‐Hb ratio); 2. Regional oxygenation of the upper trapezius (Oxy/Deoxy‐Hb ratio) ; ; These are measured by near‐infrared spectroscopy (NIRS) during each acupuncture treatment session and apply only to the two acupuncture arms, verum and placebo SECONDARY OUTCOME: 1. Medications (name, type, usage), recorded in headache diary; 2. Presence of migraine aura (Yes/No), noted by attending physician during treatment session; 3. Headache intensity (VAS score), noted by attending physician during treatment session; 4. Headache site (Left/Right), noted by attending physician during treatment session; 5. Body movement (duration of movement per 10‐min interval), recorded by video of treatment session; ; Except the measure for medications (#1), the above apply only to the acupuncture arms, verum and placebo. INCLUSION CRITERIA: 1. Diagnosed with migraine (with or without aura, according to ICHD‐II criteria) 2. Patient has given consent to receive acupuncture treatment 3. Age (20‐65) 4. Patient has provided informed consent to participate (informed about possibility of receiving placebo treatment or no acupuncture treatment, informed about the use of NIRS during acupuncture sessions)
Epistemonikos ID: a64a695b8606b91e429334fba74d4c0d90672b04
First added on: Aug 23, 2024