Acupuncture for Heel Pain Syndrome
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Bifeng Fu
- Telefonnummer: 86+18134378096
- E-post: 18134378096@163.com
Studiesteder
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Tianjin, Kina
- The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
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Ta kontakt med:
- Bifeng Fu
- Telefonnummer: 86+18134378096
- E-post: 18134378096@163.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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). |
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,
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Sham-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). |
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
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Aktiv 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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The response rate at 5 minutes after the first intervention (defined as the proportion of subjects achieving a ≥ 50% reduction in VAS scores from baseline).
Tidsramme: 14 days
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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).
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14 days
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Three-dimensional Gait Analysis
Tidsramme: The aforementioned outcome measures will be recorded and evaluated at baseline, 5 minutes after the first intervention, on days 3, 5, ..., 13, and at 2 and 6 months post-treatment.
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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.
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The aforementioned outcome measures will be recorded and evaluated at baseline, 5 minutes after the first intervention, on days 3, 5, ..., 13, and at 2 and 6 months post-treatment.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Pain response/remission rate
Tidsramme: These will be recorded and evaluated at baseline, upon completion of 1 treatment course, and at 2- and 6-months post-treatment
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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
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Functional improvement（Assessed via the Maryland Foot Score.）
Tidsramme: These will be recorded and evaluated at baseline, upon completion of 1 treatment course, and at 2- and 6-months post-treatment
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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).
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These will be recorded and evaluated at baseline, upon completion of 1 treatment course, and at 2- and 6-months post-treatment
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TJZY-GK-20250930
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