Acupuncture for Heel Pain Syndrome

Condition(s) studied

Investigational drug(s) / intervention(s)

Acupuncture: 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 Therapy: 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 Acupuncture: The patient is instructed to sit with both hands fully exposed. The practitioner applies the non-woven hollow patch over the skin. Using a 0.25 × 40 mm sterile filiform needle, the practitioner passes the needle through the lower part of the patch and positions it obliquely against the skin at a 30°-45° angle without penetration. A second patch is applied to secure the needle. No needle manipulation is performed, and no attempt is made to elicit Deqi. The patient is instructed to move and rotate the affected foot and gently stomp the heel for 1-2 minutes. Once any numbness or tingling has subsided, the patient may stand or walk slowly to assess pain relief. During the procedure, the patient is asked to concentrate on the heel pain, and the practitioner periodically monitors for discomfort. The sham needle is retained for approximately 15 minutes and then removed.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Pain response rate: (the response rate is defined as the proportion of subjects achieving a ≥ 50% reduction in VAS scores from baseline). — Assessed at 10 minutes after the first intervention
  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).

Trial sites (1)

More First Teaching Hospital of Tianjin University of Traditional Chinese Medicine trials in China