Clinical Research on Acupuncture at the Heel Pain Point for the Treatment of Heel Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Acupuncture (Procedure)
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.
干预措施: Manual Therapy (Procedure)
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).
干预措施: Sham Acupuncture (Other)
结局指标
主要结局
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).
时间窗: 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).
Three-dimensional Gait Analysis
时间窗: 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.
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).
时间窗: 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).
Three-dimensional Gait Analysis
时间窗: 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.
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.
次要结局
未报告次要终点
研究者
BiFeng Fu
Attending Physician
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine