Clinical Effect of Kinesio Taping Combined With Dry Needling to Myofascial Trigger Point on Shoulder-hand Syndrome in Hemiplegia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
The purpose of this clinical study is to investigate effects of Kinesio taping (KT) combined with dry needling (DN) on myofascial trigger points (MTrPs) in post-stroke hemiplegic shoulder-hand syndrome (SHS).
Methods: A prospective, double-blind randomized controlled trial was conducted on 84 SHS patients, who were randomized into three groups: DN (Group A), KT (Group B), and DN+KT (Group C), all receiving standard rehabilitation. VAS, ADL, FMA-UE, PROM, and 8-figure dimensional difference were assessed pre- and post-28-day treatment. Statistical analysis was performed using SPSS 27.0, with paired t-test for intragroup comparisons and independent sample t-test for intergroup comparisons, and statistical significance was set at P<0.05.
详细描述
A total of 87 patients with stage I shoulder-hand syndrome (SHS) were enrolled between November 2023 and October 2024. Diagnostic criteria followed the Chinese guidelines for acute ischemic stroke (2023) and stroke rehabilitation therapy (2011). Key diagnostic features included unilateral shoulder and hand pain, local skin flushing, increased skin temperature, limited finger flexion, and exclusion of other causes such as trauma or infection. Three participants withdrew, leaving 84 who completed the study.
Participants were randomly assigned to one of three groups (DN, KT, DN+KT) in a 1:1: ratio via a computer-generated random number table (SPSS 27.0). The sequence was concealed using sequentially numbered, sealed opaque envelopes. Group assignment was revealed only to the treating therapist at the time of intervention. Participants and outcome assessors remained blinded throughout the study.
All groups received standard rehabilitation including passive and active range-of-motion exercises, strengthening, and functional training. No analgesics or anti-inflammatory drugs were permitted.
Treatment Group A (n = 28) received DN and sham Kinesio taping: Received dry needling targeting active myofascial trigger points in shoulder muscles, performed by an experienced physician. Sham KT was applied without tension using the same tape as in the KT group.
Group B (n = 28) was treated with KT and sham DN: Received therapeutic Kinesio taping applied in multiple strips with specific tension techniques. Sham DN was performed using a needle without eliciting a local twitch response.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Within the recovery period from stroke with stable vital signs
- •Diagnosis of Stage I shoulder-hand syndrome (SHS)
- •SHS onset within 3 months prior to enrollment
- •Aged between 40 and 80 years
- •Willingness to participate in the trial and provision of signed informed consent
排除标准
- •SHS caused by brain trauma or other non-stroke etiologies
- •History of shoulder or neck pain due to cervical spondylosis or scapulohumeral periarthritis
- •Diagnosis of malignant tumors
- •Presence of psychotic disorders or other severe systemic diseases
- •Coagulation disorders
- •Skin allergies or leukemia contraindicating acupuncture treatment
- •Known skin allergy to Kinesio tape
- •Concurrent participation in other traditional Chinese medicine or interventional therapies during the trial period
- •Joint pain or dyskinesia resulting from peripheral neuropathy
研究组 & 干预措施
Group A (n = 28) received DN and sham Kinesio taping
An experienced physician performed the DN treatment. Active myofascial trigger points (MTrPs) were identified via physical examination in the deltoid, subscapularis, supraspinatus, and infraspinatus muscles. After disinfecting with alcohol, the most painful points were punctured using a sterile 0.3mm × 50mm needle (Hua Tuo, Suzhou Medical Supplies Factory Co., Ltd., China) until a local twitch response (LTR) was elicited. Upon needle removal, the investigators applied pressure with a cotton swab to prevent hematoma. The supraspinatus was needled with the participant seated, while the other muscles were treated in the prone position. For sham taping, the same type of white sports tape as used in Group B was applied-without tension-to the same anatomical area, with the participant's vision blocked.
干预措施: Dry Needling (Device)
Group A (n = 28) received DN and sham Kinesio taping
An experienced physician performed the DN treatment. Active myofascial trigger points (MTrPs) were identified via physical examination in the deltoid, subscapularis, supraspinatus, and infraspinatus muscles. After disinfecting with alcohol, the most painful points were punctured using a sterile 0.3mm × 50mm needle (Hua Tuo, Suzhou Medical Supplies Factory Co., Ltd., China) until a local twitch response (LTR) was elicited. Upon needle removal, the investigators applied pressure with a cotton swab to prevent hematoma. The supraspinatus was needled with the participant seated, while the other muscles were treated in the prone position. For sham taping, the same type of white sports tape as used in Group B was applied-without tension-to the same anatomical area, with the participant's vision blocked.
干预措施: Sham Kinesio taping (Device)
Group B (n = 28) was treated with KT and sham DN
Participants underwent eight KT applications, each retained for two days, with a two-day interval after every two applications. Standard 5-cm white KT tape was used. The protocol included: an X-shaped strip anchored at the coracoid process with 50-75% tension; an I-shaped strip applied along the supraspinatus muscle with the shoulder extended, adducted, and internally rotated, plus contralateral cervical bending; and two additional I-shaped strips reinforcing the anterior and posterior deltoid using a strengthening technique, with anchors at the outer third of the clavicle and scapula. All tapes ended without tension. The same physician performed all taping. For sham DN, a sterile 0.3×50 mm needle was used at the same MTrP locations as in the DN group, with participants' vision blocked. The sham procedure aimed to produce a tingling sensation without eliciting a local twitch response to maintain blinding.
干预措施: Kinesio Taping (Device)
Group B (n = 28) was treated with KT and sham DN
Participants underwent eight KT applications, each retained for two days, with a two-day interval after every two applications. Standard 5-cm white KT tape was used. The protocol included: an X-shaped strip anchored at the coracoid process with 50-75% tension; an I-shaped strip applied along the supraspinatus muscle with the shoulder extended, adducted, and internally rotated, plus contralateral cervical bending; and two additional I-shaped strips reinforcing the anterior and posterior deltoid using a strengthening technique, with anchors at the outer third of the clavicle and scapula. All tapes ended without tension. The same physician performed all taping. For sham DN, a sterile 0.3×50 mm needle was used at the same MTrP locations as in the DN group, with participants' vision blocked. The sham procedure aimed to produce a tingling sensation without eliciting a local twitch response to maintain blinding.
干预措施: Sham Dry Needling (Device)
Group C (n = 28) was treated with KT combined with DN.
Participants received both active DN and KT interventions
干预措施: Dry Needling (Device)
Group C (n = 28) was treated with KT combined with DN.
Participants received both active DN and KT interventions
干预措施: Kinesio Taping (Device)
结局指标
主要结局
Pain Intensity
时间窗: Baseline, 14 days, and 28 days post-treatment.
Pain intensity was assessed using the Visual Analog Scale (VAS). The scale consists of a 10-cm horizontal line with endpoints labeled "0" (no pain) and "10" (worst pain possible). Patients marked their perceived pain level on the line, with scores rounded to the nearest 0.25. Higher scores indicate more severe pain.
Upper Limb Motor Function
时间窗: Baseline, 14 days, and 28 days post-treatment.
The simplified Fugl-Meyer Assessment for Upper Extremity (FMA-UE) was used to evaluate upper limb motor function. The total score is 66 points, with higher scores indicating better upper limb motor function.
次要结局
- Degree of Finger Edema(Baseline, 14 days, and 28 days post-treatment.)
- Passive Range of Motion of the Shoulder Joint(Baseline, 14 days, and 28 days post-treatment.)
- Activities of Daily Living(Baseline, 14 days, and 28 days post-treatment.)