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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Bifeng Fu
- 電話番号：86+18134378096
- メール：18134378096@163.com
研究場所
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Tianjin、中国
- The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
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コンタクト：
- Bifeng Fu
- 電話番号：86+18134378096
- メール：18134378096@163.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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偽コンパレータ：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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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).
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Pain response/remission rate
時間枠：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.）
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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