Effectiveness of electroacupuncture and manual acupuncture in patients with tension-type headache: a study protocol for a randomized, usual care-controlled, three-arm clinical trial

This single-blind (outcome assessors and the data analyst blinded), parallel-group, randomized clinical trial evaluates the effectiveness of electroacupuncture (EA) compared to manual acupuncture (MA) and usual care in patients with tension-type headache (TTH). Seventy-five adults (18-65 years) with chronic or episodic TTH, ≥1-year headache history, and ≥3 months of stable treatment will be enrolled. Both acupuncture groups will receive 12 sessions over 4 weeks (3 per week, 30 min) using 14 paired and 3 midline acupoints. Procedures will be identical in both groups, including acupoints and electrode placement; however, electrical stimulation will be applied only in the EA group to allow blinded evaluation of its incremental effect. All three groups will continue their prior medication. The primary outcome will be headache intensity. Secondary outcomes will include headache days, total headache hours, acute medication use, quality of life, anxiety, and depression. Assessments will occur at baseline and at weeks 4, 8, and 12. Nonpharmacological treatments for TTH are increasingly important to prevent medication overuse and side effects. Although acupuncture is widely used, the relative effectiveness of EA and MA remains uncertain, limiting clinical decision-making. This trial is among the first to address this gap and may help guide treatment choices.Clinical trial registration: The Iranian Registry of Clinical Trials identifier is IRCT20230626058585N1.