Article Text
Abstract
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.
- acupuncture
- randomized controlled trial
- plantar heel pain syndrome
- protocol
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Footnotes
Contributors ZL is responsible for supervising the clinical study and for communicating important protocol modifications to relevant parties. WW and ZL conceived the idea and designed this trial. RJ is responsible for the recruitment and treatment of patients. YL and JZ are responsible for statistical analysis. This manuscript was drafted by WW and revised by ZL. All authors read and approved the final draft of the manuscript.
Funding This RCT is funded by Guang’anmen Hospital, China Academy of Chinese Medical Sciences, China (Grant No. 2017S393).
Competing interests None declared.
Ethics approval Ethical Committee of the Guang’anmen Hospital, China Academy of Chinese Medical Sciences (No. 2018-010-KY).
Provenance and peer review Not commissioned; externally peer reviewed.
Patient consent for publication Not required.