An interventional study of Acupuncture and Manual Therapy in Heel Pain Syndrome, sponsored by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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 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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 150 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →First Teaching Hospital of Tianjin University of Traditional Chinese Medicine is the lead sponsor of 15 studies on the registry; 11 are open to participants now.
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The criteria were revised on the registry on Oct 14, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Procedure: Acupuncture
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.
Procedure: Manual Therapy
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).
Other: Sham 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,
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.
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.
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).
Time frame: Assessed at 10 minutes after the first intervention
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%.
Time frame: These will be recorded and evaluated at baseline, upon completion of 1 treatment course, and at 3 months post-treatment
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).
Time frame: These will be recorded and evaluated at baseline, upon completion of 1 treatment course, and at 3 months post-treatment
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,
Time frame: at baseline, 10 minutes after each of the seven treatment sessions, and 3 months after completion of the treatment course.
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.
Time frame: 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.
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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First Teaching Hospital of Tianjin University of Traditional Chinese Medicine