Background: In this randomized, double-blind, parallel-group trial, we aimed to explore the effectiveness of trigger point dry needling in patients with chronic tension-type headache in reducing headache frequency, intensity and duration, and improvement of health-related quality of life. Methods: The 168 patients in 2 neurology clinics with chronic tension-type headache. The participants were randomly assigned to one of two treatment groups for dry needling or sham dry needling, delivered in 3 sessions a week for 2 weeks. The 160 patients fulfilled the study requirements. The dry needling was applied in active trigger points located in the musculature of the head and the neck. The patients received dry needling using sterile stainless-steel acupuncture needles of 0.25 × 40 mm and 0.25 × 25 mm dimensions. The sham dry needling procedure was applied into the adipose tissue located at any area where an active trigger point was absent. The primary outcome measurement was the headache intensity. Secondary outcomes were frequency and duration of headache, and quality of life, assessed by the Short Form-36. All outcomes were measured at baseline, at the end of 2-week, and 1-month follow-up period. Results: In the dry needling group, intensity, frequency and duration of headache, and the scores of Short Form-36 subscales were significantly improved after treatment ( P < .05). In the dry needling group, all the effect sizes for headache variables were large. Conclusions: The results of this clinical trial suggest that trigger point dry needling in patients with chronic tension-type headache is effective and safe in reducing headache intensity, frequency and duration, and increasing health-related quality of life. Trial registration: Clinical Trials NCT03500861.