The Treatment of Shoulder-hand Syndrome in Hemiplegia Patients

Handan Central Hospital

Status: Completed

Conditions: Shoulder-hand Syndrome

Treatments: Device: Dry Needling; Device: Kinesio Taping; Device: Sham Dry Needling; Device: Sham Kinesio taping

Study type: Interventional

Funder types: Other

Identifiers

NCT07245472

HandanCentral

Details and patient eligibility

About

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.

Full description

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.

Group C (n = 28) was treated with KT combined with DN: Received both active DN and KT interventions.

Enrollment: 84 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 3 patient groups

Group A (n = 28) received DN and sham Kinesio taping

Experimental group

Description:

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.

Treatment:

Device: Sham Kinesio taping

Device: Dry Needling

Group B (n = 28) was treated with KT and sham DN

Experimental group

Description:

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.

Treatment:

Device: Sham Dry Needling

Device: Kinesio Taping

Group C (n = 28) was treated with KT combined with DN.

Experimental group

Description:

Participants received both active DN and KT interventions

Treatment:

Device: Kinesio Taping

Device: Dry Needling