Acupuncture for Heel Pain Syndrome

Starting soon · Not applicable · Has a placebo group

Conditions studied: Heel Pain Syndrome

In brief

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.

Key facts

Study ID

NCT07607223

Run by

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

People needed

150

Starts

2026-09-01

Expected to finish

2027-10-30

Last updated by the study team

2026-08-03

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meeting the aforementioned Western medicine diagnostic criteria for heel pain.
• Aged 40-70 years with a disease duration of less than two months and no prior relevant treatments.
• Voluntary provision of informed consent and willingness to receive the corresponding treatments.
• Presence of calcaneal spurs on X-ray radiography is permitted.

You may not qualify if…

• Presence of gout, trauma, osteomyelitis, or purulent inflammation in the affected area.
• Concomitant history of heel trauma with localized redness, swelling, heat, and inflammatory reactions.
• Chronic conditions that may confound treatment efficacy or outcome interpretation (e.g., cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, dementia, epilepsy, or other disqualifying conditions).
• Radicular pain accompanied by lower extremity muscle weakness, sensory loss, diminished reflexes, progressive neurological deficits, or severe neurological symptoms.
• Contraindications to acupuncture (e.g., hemorrhagic diseases, coagulopathy, history of anticoagulant therapy, severe diabetes with infection risk, severe cardiovascular disease).
• History of adverse reactions to acupuncture or alcohol allergies.
• Currently pregnant or planning to conceive.
• Deemed unsuitable for study inclusion by the investigators.

Where it is running

• The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine — Tianjin, China

Full record on ClinicalTrials.gov

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