Lateral epicondylalgia (LE), a common overuse syndrome of the extensor muscle and tendons on the lateral epicondyle, causes persistent severe musculoskeletal pain on the outer part of the elbow. Fu's subcutaneous needling (FSN), a newly invented subtype of acupuncture and dry needling, is a new trend and potential treatment of LE by targeting the myofascial trigger points (MTrPs). However, no scientific evidence is available to support this method. This study aims to evaluate the distal FSN treatment on the LE by measuring pain-related scales, such as visual analog scale (VAS), pressure pain threshold (PPT), muscle tissue hardness (TH), pain-free grip (PFG), and the functional outcome by a patient-rated tennis elbow evaluation (PRTEE) questionnaire study. A total of 60 LE patients were randomly divided into FSN (n = 30) and transcutaneous electrical nerve stimulation (TENS, n = 30) as the control group. Every subject was treated with three regimens and followed up for 15 days. Results showed that FSN has an immediate effect on VAS, PPT, TH, and PFG. Moreover, sustained effects on pain relief were followed up to 15 days. Pain remission was consistent with long-term PRTEE results. Overall, FSN is a safe and efficient therapy option for LE, significantly improving pain relief and activity difficulty with immediate, short-term, and long-term effectiveness. This trial is registered with ClinicalTrials.gov NCT03605563.

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