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Heel Pain SyndromeNCT07607223

Acupuncture for Heel Pain Syndrome

A study testing Acupuncture and Manual Therapy in people with Heel Pain Syndrome, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Heel Pain Syndrome
What is being tested?
Acupuncture and Manual Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteChina
Study dates
15 Oct 2026to 30 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meeting the aforementioned Western medicine diagnostic criteria for heel pain.
  • Age between 40 and 70 years, with no relevant treatment received within the preceding 2 months.
  • Voluntary provision of informed consent and willingness to receive the corresponding treatments.
  • Presence of calcaneal spurs on X-ray radiography is permitted.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

    Tianjin

    Bifeng Fu, 86+18134378096, 18134378096@163.com

Other trials in China

About this study

Official title: Clinical Research on Acupuncture at the Heel Pain Point for the Treatment of Heel Pain Syndrome

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).

Read more

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.

Being tested
Acupuncture, Manual Therapy, Sham Acupuncture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupunctureProcedure or surgery

    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 or surgery

    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

    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 groups in NCT07607223
Study groupRoleWhat they receive
Acupuncture GroupExperimentalAcupoint 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).
Receives: Procedure: Acupuncture
Manual Therapy GroupActive comparatorParticipants 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.
Receives: Procedure: Manual Therapy
Sham Acupuncture Control GroupSham comparatorAcupoint 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).
Receives: Other: Sham Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Assessed at 10 minutes after the first intervention

Secondary outcomes (4)
  1. 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%.

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

  2. 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).

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

  3. Changes in VAS Scores

    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,

    Measured: at baseline, 10 minutes after each of the seven treatment sessions, and 3 months after completion of the treatment course.

  4. 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.

    Measured: These parameters will be assessed at baseline, 10 minutes after each of the seven treatment sessions, and 3 months after completion of the treatment course.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2026
  2. Study start15 Oct 2026 (estimated)
  3. Primary completion30 Oct 2027 (estimated)
  4. Study completion30 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07607223
Sponsor's protocol ID
TJZY-GK-20250930
Status last verified
Jul 2026
First submitted
13 May 2026
Last updated
14 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture and Manual Therapy in people with Heel Pain Syndrome, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bifeng Fu (86+18134378096, 18134378096@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain response rate: (the response rate is defined as the proportion of subjects achieving a ≥ 50% reduction in VAS scores from baseline). (time frame: Assessed at 10 minutes after the first intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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