Acupuncture for Heel Pain Syndrome

NCT07607223 | Not Yet Recruiting

• 1 other identifier: TJZY-GK-20250930
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Heel Pain Syndrome

Outcome Measures

Primary Outcomes (2)

• VAS scores measured at baseline, 5 and 10 minutes post-acupuncture , and on Days 3, 5... through 13 and the response rate for each immediate effect (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).

  14 days

• 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.

  at baseline, 5 and 10 minutes post-acupuncture (immediate effect), and on Days 3, 5... through 13, as well as at 2 and 6 months post-treatment.

Secondary Outcomes (2)

• Pain response/remission rate

  These will be recorded and evaluated at baseline, upon completion of 1 treatment course, and at 2- and 6-months post-treatment

• Functional improvement（Assessed via the Maryland Foot Score.）

  These will be recorded and evaluated at baseline, upon completion of 1 treatment course, and at 2- and 6-months post-treatment

Study Arms (3)

Acupuncture Group

EXPERIMENTAL

Acupoint Selection: Contralateral point selection (i.e., the left heel pain point is selected for right heel pain, and vice versa). Heel Pain Point: Located on the palm, 0.8 cun distal to the Daling acupoint (PC7, located on the anterior aspect of the wrist, in the depression of the distal wrist crease, between the tendons of palmaris longus and flexor carpi radialis), toward the thenar eminence. Primary Needles: Hwato brand (0.25 × 40 mm, Suzhou, China). Primary Patch: Spunlace non-woven hollow patch (with cotton) (5 × 5 cm, ring diameter 2.3 cm, cotton diameter 1.5 cm, Yingrui Pharmaceuticals).

Procedure: Acupuncture

Manual Therapy Group

ACTIVE COMPARATOR

Participants lie supine with the affected lower limb relaxed. Manual therapy consists of: (1) thumb kneading and pressure applied to the painful plantar region for 5-10 minutes according to patient tolerance; (2) horizontal stretching by stabilizing the heel while dorsiflexing the ankle to stretch the Achilles tendon and triceps surae (5-10 repetitions, 30 s each); (3) straight-leg raise stretching with ankle dorsiflexion until gastrocnemius tension is achieved; and (4) clockwise and counterclockwise ankle rotation (3 circles each), repeated 3-4 times for 30 s. Treatments are administered every other day for seven sessions.

Procedure: Manual Therapy

Sham Acupuncture Control Group

SHAM COMPARATOR

Acupoint Selection: Contralateral point selection (i.e., the left heel pain point is selected for right heel pain, and vice versa). Heel Pain Point: Located on the palm, 0.8 cun distal to the Daling acupoint (PC7, located on the anterior aspect of the wrist, in the depression of the distal wrist crease, between the tendons of palmaris longus and flexor carpi radialis), toward the thenar eminence. Primary Needles: Hwato brand (0.25 × 40 mm, Suzhou, China). Primary Patch: Spunlace non-woven hollow patch (with cotton) (5 × 5 cm, ring diameter 2.3 cm, cotton diameter 1.5 cm, Yingrui Pharmaceuticals).

Other: Sham Acupuncture

Interventions

Acupuncture PROCEDURE

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,

Acupuncture Group

Manual Therapy PROCEDURE

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.

Manual Therapy Group

Sham Acupuncture OTHER

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

Sham Acupuncture Control Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Wangjing Hospital, China Academy of Chinese Medical Sciences: collaborator
• First Teaching Hospital of Tianjin University of Traditional Chinese Medicine: lead
• The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine: collaborator

Study Sites (1)

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, China

Location

MeSH Terms

Interventions

Acupuncture Therapy; Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Bifeng Fu

CONTACT

86+18134378096; 18134378096@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)