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 the immediate analgesic effect after each treatment session and the sustained clinical benefits after completion of treatment and at the 3-month follow-up.
Ensure Safety: Monitor adverse events and treatment-related complications throughout the study to evaluate 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 the established diagnostic criteria.
Disease Duration: No specific restriction on disease duration is stated; however, participants must not have received related treatment within the preceding 2 months.
Typical Symptoms: Participants with characteristic medial plantar heel pain, particularly during the first steps after rest, localized tenderness at the calcaneal attachment of the plantar fascia, a positive Windlass test, limited ankle dorsiflexion, or abnormal foot posture.
Exclusions: Individuals with gout, heel trauma, osteomyelitis, purulent inflammation, severe neurological deficits, conditions that may interfere with outcome assessment, contraindications to acupuncture, a history of adverse reactions to acupuncture, pregnancy or plans to conceive, or other conditions considered unsuitable by the investigators.
Primary Research Endpoint The primary endpoint is designed to determine whether Heel Pain Point acupuncture provides superior immediate pain relief 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 at 10 minutes after the first intervention.
Pain Intensity: Changes in VAS scores will be assessed at baseline, 10 minutes after each of the seven treatment sessions, and 3 months after completion of the treatment course.
Objective Functional Recovery: Three-dimensional gait analysis will evaluate changes in gait speed, single-leg stance stability, foot axis and progression angle, initial contact angle, push-off angle, and ground clearance. Foot function will also be assessed using the Maryland Foot Score.
Evaluation Timing: VAS scores and three-dimensional gait parameters will be assessed at baseline, 10 minutes after each treatment session, and at the 3-month follow-up. Clinical efficacy and Maryland Foot Scores will be assessed at baseline, after completion of the seven-session treatment course, and at the 3-month follow-up.