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Acupuncture for Heel Pain Syndrome

11. Juli 2026 aktualisiert von: 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 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

150

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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).
Verfahren: 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,
Schein-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).
Sonstiges: Sham Acupuncture
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
Aktiver Komparator: Manual Therapy Group
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.
Verfahren: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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).
Zeitfenster: 14 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).
14 days
Three-dimensional Gait Analysis
Zeitfenster: 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.
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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain response/remission rate
Zeitfenster: 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.）
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Mitarbeiter

Wangjing Hospital, China Academy of Chinese Medical Sciences
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

30. Oktober 2027

Studienabschluss (Geschätzt)

30. Oktober 2027

Studienanmeldedaten

Zuerst eingereicht

13. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Mai 2026

Zuerst gepostet (Tatsächlich)

26. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • TJZY-GK-20250930

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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