The main goal of this study is to determine whether acupuncture at the Heel Pain Point, a distal acupuncture point located on the palm, is an effective and safe treatment for heel pain syndrome. This randomized controlled trial compares Heel Pain Point acupuncture with manual therapy and sham acupuncture to evaluate both clinical efficacy and functional recovery. Specifically, the researchers aim to:
Measure Pain Relief: Evaluate whether Heel Pain Point acupuncture provides greater pain reduction than manual therapy and sham acupuncture using the Visual Analog Scale (VAS).
Assess Walking Function: Determine whether the intervention improves gait performance and foot function through three-dimensional gait analysis and the Maryland Foot Score.
Evaluate Immediate and Long-term Effects: Examine both the immediate analgesic effect after each treatment session and the sustained clinical benefits after completion of treatment and during follow-up.
Ensure Safety: Monitor adverse events and treatment-related complications throughout the study to confirm the safety of the intervention.
Target Population
The study is recruiting participants who meet the following criteria:
Age: Adults between 40 and 70 years.
Diagnosis: Individuals diagnosed with heel pain syndrome (primarily plantar fasciitis) according to established diagnostic criteria.
Disease Duration: Symptoms lasting less than two months, with no previous related treatment.
Typical Symptoms: Participants experiencing characteristic medial plantar heel pain, especially during the first steps after rest, localized tenderness at the plantar fascia insertion, limited ankle dorsiflexion, and abnormal foot posture.
Exclusions: Individuals with heel trauma, gout, osteomyelitis, inflammatory disorders, severe neurological deficits, contraindications to acupuncture, pregnancy, or serious systemic diseases (such as severe cardiovascular disease or uncontrolled diabetes).
Primary Research Endpoint
The primary endpoint is designed to determine whether Heel Pain Point acupuncture provides superior clinical benefit compared with manual therapy and sham acupuncture.
Pain Response Rate: The primary efficacy endpoint is the proportion of participants achieving at least a 50% reduction in VAS pain score from baseline after one complete treatment course.
Pain Intensity: Changes in Visual Analog Scale (VAS) scores will also be assessed to quantify pain reduction.
Objective Functional Recovery: Three-dimensional gait analysis will be used to evaluate improvements in gait speed, single-leg stability, foot progression angle, initial contact angle, push-off angle, and ground clearance.
Evaluation Timing: Primary outcomes will be assessed at baseline, immediately after treatment sessions (5 and 10 minutes), throughout the treatment period, after completion of the seven-session treatment course, and at 2-month and 6-month follow-up visits. These assessments are designed to capture both immediate analgesic effects and sustained clinical outcomes.