Acupuncture for Heel Pain Syndrome: A Multicenter Randomized Controlled Trial

Tianjin University of Traditional Chinese Medicine

Status: Begins enrollment in 2 months

Conditions: Heel Pain Syndrome

Treatments: Other: Sham Acupuncture; Procedure: Manual Therapy; Procedure: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT07607223

TJZY-GK-20250930

Details and patient eligibility

About

The main goal of this study is to determine if a specific acupuncture technique-targeting a "heel pain point" located on the hand-is an effective and safe way to treat heel pain. Specifically, the researchers want to:

Measure Pain Relief: Evaluate how effectively the treatment reduces pain levels.

Check Physical Function: Determine if the treatment helps patients walk and move more comfortably.

Ensure Safety: Track any side effects or adverse reactions to confirm the treatment is safe for patients.

Target Population

The study is looking for participants who meet the following criteria:

Age: Adults between 40 and 70 years old. Diagnosis: Individuals diagnosed with heel pain (plantar fasciitis). Duration: People who have had the pain for less than two months and have not recently received other related treatments.

Typical Symptoms: Individuals who experience significant pain during their first few steps in the morning or after sitting for a long time.

Exclusions: The study excludes people with recent foot injuries, gout, or serious underlying health conditions such as severe diabetes or heart disease.

Primary Research Endpoint

The "Primary Endpoint" is the specific result the researchers use to decide if the treatment was successful:

The 50% Reduction Goal: The study measures the "response rate," which is the percentage of patients whose pain score decreases by at least 50% compared to their starting pain level.

Evaluation Timing: This success measure is evaluated after the patient completes one full course of treatment, which consists of 10 sessions given over approximately 20 days.

Enrollment: 150 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Acupuncture Group

Experimental group

Description:

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).

Treatment:

Procedure: Acupuncture

Manual Therapy Group

Active Comparator group

Description:

The patient is positioned supine with the affected lower limb completely relaxed. (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 han

Treatment:

Procedure: Manual Therapy

Sham Acupuncture Control Group

Sham Comparator group

Description:

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).

Treatment:

Other: Sham Acupuncture