The Treatment of Shoulder-hand Syndrome in Hemiplegia Patients

NCT ID: NCT07245472

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-10-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dry Needling

Intervention Type: DEVICE

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.

Sham Kinesio taping

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Sham Dry Needling

Intervention Type: DEVICE

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.

Kinesio Taping

Intervention Type: DEVICE

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.

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

Participants received both active DN and KT interventions

Group Type: EXPERIMENTAL

Dry Needling

Intervention Type: DEVICE

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.

Kinesio Taping

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Handan Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Handan Central Hospital

Handan, Hebei, China

Countries

China

Other Identifiers

HandanCentral

Identifier Type: -

Identifier Source: org_study_id