Electroacupuncture versus manual acupuncture in the treatment of plantar heel pain syndrome: study protocol for an upcoming randomised controlled trial.

INTRODUCTION

Plantar heel pain syndrome(PHPS) is a common cause of heel pain. It may worsen a patient's quality of life, and potentially lead to knee, hip or lower back problems. Previous studies have shown that electroacupuncture (EA) and manual acupuncture (MA) are effective treatments for relieving pain in patients with PHPS. However, little evidence supports the use of one intervention over the other.

METHODS AND ANALYSIS

A total of 92 patients diagnosed with PHPS will be recruited and randomly assigned to an EA group or an MA group at a ratio of 1:1. Patients in both groups will receive a 30 min acupuncture treatment (three times per week) for a total of 12 sessions over 4 weeks. The primary outcome will be the proportion of patients with at least 50% reduction from baseline in the worst pain intensity measured by visual analogue scale (0-100, higher scores signify worse pain) at first steps in the morning after 4-week treatment. The secondary outcomes will include change in worst pain intensity at first steps in the morning, change in mean pain intensity at first steps in the morning, change in worst pain intensity during the day, change in mean pain intensity during the day, change in the pressure pain threshold, change in ankle-dorsiflexion range of motion, change in Foot and Ankle Ability Measure total score and subscale scores, patients' global improvement assessment, patients' expectations for acupuncture and safety evaluation. We will perform all statistical analysis following the intention-to-treat principle.

ETHICS AND DISSEMINATION

The study has been approved by our ethics review board (Protocol Approval No. 2018-010-KY). The study findings will be disseminated through presentation at a high-impact medical journal, with online access. We also to plan to present it in select conferences and scientific meetings.

TRIAL REGISTRATION

ChiCTR-1800016531; Pre-results.