Acupuncture for Heel Pain Syndrome

N/ANot Yet RecruitingNCT07607223

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine150 enrolled

Overview

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 、10and 15 minutes), throughout the treatment period, after completion of the seven-session treatment course, and at 3 month follow-up visits. These assessments are designed to capture both immediate analgesic effects and sustained clinical outcomes.

Interventions

AcupuncturePROCEDURE

The patient is instructed to sit with both hands fully exposed. The practitioner applies the non-woven hollow patch over the skin. Using a 0.3 × 40 mm sterile filiform needle, the practitioner pierces the hollow patch and inserts the needle obliquely downward at a 30°-45° angle to the skin, reaching a depth of 10-15 mm at the heel pain point. An even reinforcing and reducing manipulation (Ping Bu Ping Xie) is applied with small-amplitude, uniform lifting, thrusting, and twirling. Needle insertion stops upon the arrival of Deqi (sensation of soreness, numbness, distension, or pain). The patient is instructed to move, rotate, and stomp the affected heel for 1-2 minutes. After stomping, manipulation ceases; once the numbness in the foot subsides, the patient may stand or walk slowly to assess pain relief. During the procedure, the patient should concentrate on the heel pain, and the operator will periodically monitor for any discomfort. Needles are retained for approximately 15 minutes,

Manual TherapyPROCEDURE

1. Kneading and pressing techniques are applied to the affected area using the thumb, with intensity tailored to patient tolerance; focus is placed on localized cord-like structures or fibrous nodules for 5-10 min per session. 2. Horizontal Stretching: With the patient supine and the lower limb extended, the practitioner stabilizes the heel with one hand and pushes the forefoot with the base of the other palm, maximally dorsiflexing the ankle until tension is felt in the Achilles tendon and triceps surae. This stretch is performed 5-10 times for 30 seconds each. 3. Straight-Leg Raise Stretching: The practitioner elevates the affected limb while maintaining knee extension. With the left hand on the heel and the right hand gripping the forefoot, the practitioner leans backward to dorsiflex the ankle until gastrocnemius tension is felt. 4. Ankle Rotation: Building upon step (3), the right hand rotates the forefoot around the heel clockwise and counterclockwise, three circles each.

Sham AcupunctureOTHER

Preparation is identical to the acupuncture group. The filiform needle is passed through the lower part of the hollow patch and placed obliquely downward against the skin at a 30°-45° angle without penetrating it. A secondary patch is then applied, with its adhesive backing peeled off, and secured smoothly and flatly against the patient's skin surface.No manual needle manipulation is performed. The patient is instructed to remain seated quietly and refrain from any movement to prevent the needle tip from penetrating the skin, thereby avoiding any inadvertent therapeutic acupuncture effects.Needles are retained for approximately 15 minutes, and upon withdrawal, the puncture site is pressed with a dry cotton ball. Treatment is administered every other day, with seven sessions constituting one therapeutic course

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Meeting the aforementioned Western medicine diagnostic criteria for heel pain. 2. Aged 40-70 years with a disease duration of less than two months and no prior relevant treatments. 3. Voluntary provision of informed consent and willingness to receive the corresponding treatments. 4. Presence of calcaneal spurs on X-ray radiography is permitted. Exclusion Criteria: 1. Presence of gout, trauma, osteomyelitis, or purulent inflammation in the affected area. 2. Concomitant history of heel trauma with localized redness, swelling, heat, and inflammatory reactions. 3. 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). 4. Radicular pain accompanied by lower extremity muscle weakness, sensory loss, diminished reflexes, progressive neurological deficits, or severe neurological symptoms. 5. Contraindications to acupuncture (e.g., hemorrhagic diseases, coagulopathy, history of anticoagulant therapy, severe diabetes with infection risk, severe cardiovascular disease). 6. History of adverse reactions to acupuncture or alcohol allergies. 7. Currently pregnant or planning to conceive. 8. Deemed unsuitable for study inclusion by the investigators.

Outcomes

Primary Outcomes

Pain response rate: (the response rate is defined as the proportion of subjects achieving a ≥ 50% reduction in VAS scores from baseline).

VAS Score: A 10-cm visual analog scale where 0 represents no pain and 10 represents severe pain (1-3: mild; 4-6: moderate; 7-10: severe).

Time frame: Assessed at 5, 10, and 15 minutes after the first intervention

Three-dimensional Gait Analysis

This study utilizes the "Right Gait Posture" Medical 3.0 dynamic gait analysis system (Shenzhen Xingzheng Technology Co., Ltd., China), selecting six parameters to evaluate the patient's walking ability: gait speed, single-leg stance stability, changes in foot axis and progression angle, initial contact angle, push-off angle, and ground clearance.

Time frame: at baseline and at 5, 10, and 15 minutes after the first intervention

Secondary Outcomes

Pain response/remission rate

Clinical Remission Criteria: Based on the Criteria of Diagnosis and Therapeutic Effect of Diseases and Syndromes in Traditional Chinese Medicine (State Administration of Traditional Chinese Medicine). Cured: Free walking, no mobility restrictions, complete resolution of heel pain. Markedly Effective: Nearly normal walking, mild discomfort only after prolonged walking, significant improvement in mobility, basic resolution of heel pain. Effective: Slight restriction during walking/activity, mild heel pain. Ineffective: Persistent restriction in walking/activity, no relief in heel pain. Total Effective Rate = (Cured + Markedly Effective + Effective) / Total Cases ×100%.

Time frame: These will be recorded and evaluated at baseline, upon completion of 1 treatment course, and at 3 months post-treatment

Functional improvement（Assessed via the Maryland Foot Score.）

Maryland Foot Score: Evaluates pain, function, appearance, and mobility. Higher scores indicate better foot function (Excellent: 90-100, Good: 75-89, Fair: 50-74, Poor: \<50).

Time frame: These will be recorded and evaluated at baseline, upon completion of 1 treatment course, and at 3 months post-treatment

Pain response rate and VAS score

The VAS utilizes a 10-cm visual analog scale, where 0 represents no pain and 10 represents severe pain. the pain response rate, defined using the same criterion as the primary outcome,

Time frame: Immediately after treatment sessions 2-7 (Days 3, 5, 7, 9, 11, and 13 after initiation of treatment), and 3 months after completion of the 7-session treatment course.

Three-dimensional Gait Analysis

Utilizing the same six gait parameters as the primary outcome This study utilizes the "Right Gait Posture" Medical 3.0 dynamic gait analysis system (Shenzhen Xingzheng Technology Co., Ltd., China), selecting six parameters to evaluate the patient's walking ability: gait speed, single-leg stance stability, changes in foot axis and progression angle, initial contact angle, push-off angle, and ground clearance.

Time frame: assessments will be conducted at baseline, upon completion of one treatment course, and at 3 months post-treatment.