Acupuncture for Heel Pain Syndrome: A Multicenter Randomized Controlled Trial
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Bifeng Fu
- 전화번호: 86+18134378096
- 이메일: 18134378096@163.com
연구 장소
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Tianjin, 중국
- The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
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연락하다:
- Bifeng Fu
- 전화번호: 86+18134378096
- 이메일: 18134378096@163.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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, a
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활성 비교기: 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
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The patient is positioned supine with the affected lower limb completely relaxed.
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가짜 비교기: 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 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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The response rate after one course of acupuncture intervention （defined as the proportion of subjects achieving a ≥50% reduction in VAS score from baseline）
기간: 20 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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20 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain response/remission rate
기간: 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.）
기간: 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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Satisfaction：Patient Satisfaction: Statistical proportion of satisfaction calculated as [(Satisfied + Basically Satisfied) / Total Patients] $\times$ 100%.
기간: 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 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
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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