NCT07245472

The Treatment of Shoulder-hand Syndrome in Hemiplegia Patients

Clinical Effect of Kinesio Taping Combined With Dry Needling to Myofascial Trigger Point on Shoulder-hand Syndrome in Hemiplegia Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Handan Central Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Shoulder-hand Syndrome

Interventions

Type	Name	Description
DEVICE	Dry Needling	The deltoid, subscapularis, supraspinatus,and infraspinatus muscles were examined through physical examination to determine the active myofascial trigger points (MTrPs). After disinfection with alcohol, a sterile needle with a diameter of 0.3mm\*50mm (China, Suzhou Medical Supplies Factory Co., Ltd.Hua Tuo) was used to puncture the most painful points until a local twitch response (LTR) was obtained. After removing the needle,we pressed it with a cotton swab to prevent local hematoma. The prone position was adopted for the infraspinatus, deltoid and subscapular muscles, and sitting position was adopted for DN treatment of the supraspinatus.
DEVICE	Sham Kinesio taping	For the treatment with the sham Kinesio taping, Researchers used the sports white tape of the same specification as the Kinesio taping , and blocked the vision of the participants to apply the same dose as that in Kinesio taping to the same area where the Kinesio taping was applied, so that it could be applied to the skin of the same area where the Kinesio taping was applied without pulling force.
DEVICE	Kinesio Taping	Patients received eight therapeutic kinesiology taping (KT) sessions. Each application remained for two days, with a two-day interval after every two treatments. Standard 5-cm white KT was used.A 10-cm X-shaped tape was first applied with its center anchored at 50-75% tension over the coracoid process under downward pressure; the tails were laid without tension.A second I-shaped tape was applied with the strengthening technique along the supraspinatus muscle from origin to insertion, with the shoulder extended, adducted, and internally rotated, and the neck contralaterally flexed. The ends (2.5-5 cm) were fixed without tension.The third and fourth I-shaped tapes targeted the anterior and posterior deltoid. With the patient seated, anchors were placed on the lateral clavicle and scapula. The tape was stretched over the deltoid with the shoulder horizontally extended and externally rotated into abduction.
DEVICE	Sham Dry Needling	For sham DN treatment, Researchers used a 0.3mm\*50 mm sterile needle (China, Suzhou Medical Supplies Factory Co., Ltd., Hua Tuo) and blocked the participants eyesight with the DN group of the same dose used in the local MTrP of the same area. The effectiveness of the blinding strategy was verified through experiments based on the criterion of causing a tingling sensation without causing LTR.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2025-11-24
• Last updated: 2025-11-24

Locations

1 site across 1 country: China