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Acupuncture for Heel Pain Syndrome: A Multicenter Randomized Controlled Trial

19 maja 2026 zaktualizowane przez: BiFeng Fu, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

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 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

150

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Chiny
      • Tianjin, Chiny
        • The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Acupuncture Group

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).
Procedura: 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, a
Aktywny komparator: Manual Therapy Group
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
Procedura: Manual Therapy

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
Pozorny komparator: Sham Acupuncture Control Group

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).
Inny: Sham Acupuncture
Preparation is identical to the acupuncture group. The filiform needle is placed against the skin at a 30°-45° angle through the hollow patch but does not penetrate the skin. A secondary patch is applied to secure the needle flat against the skin surface. No needle manipulation is performed. The patient is instructed to sit quietly without movement to prevent inadvertent skin penetration. Needles are retained for 15 minutes. Conducted every other day, with ten sessions constituting one therapeutic course.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
The response rate after one course of acupuncture intervention （defined as the proportion of subjects achieving a ≥50% reduction in VAS score from baseline）
Ramy czasowe: 20 days
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).
20 days

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Pain response/remission rate
Ramy czasowe: These will be recorded and evaluated at baseline, upon completion of 1 treatment course, and at 2- and 6-months post-treatment

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%.
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.）
Ramy czasowe: These will be recorded and evaluated at baseline, upon completion of 1 treatment course, and at 2- and 6-months post-treatment
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).
These will be recorded and evaluated at baseline, upon completion of 1 treatment course, and at 2- and 6-months post-treatment
Satisfaction：Patient Satisfaction: Statistical proportion of satisfaction calculated as [(Satisfied + Basically Satisfied) / Total Patients] $\times$ 100%.
Ramy czasowe: These will be recorded and evaluated at baseline, upon completion of 1 treatment course, and at 2- and 6-months post-treatment

Clinical Symptoms and Signs Score for Heel Pain: Comprises 4 domains (pain during walking, pain upon pressure, walking function, and comparative swelling), totaling 12 points. Higher scores indicate greater severity.

Gait Analysis: Conducted using a dynamic gait and posture analysis system (Right Gait Postur Medical 3.0, Shenzhen) at baseline and post-treatment. The system records and analyzes plantar pressure distribution, center of pressure, peak pressure, and pressure variance to visually evaluate treatment efficacy.
These will be recorded and evaluated at baseline, upon completion of 1 treatment course, and at 2- and 6-months post-treatment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

30 października 2027

Ukończenie studiów (Szacowany)

30 października 2027

Daty rejestracji na studia

Pierwszy przesłany

13 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

19 maja 2026

Pierwszy wysłany (Rzeczywisty)

26 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

19 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • TJZY-GK-20250930

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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