The Treatment of Shoulder-hand Syndrome in Hemiplegia Patients

NCT07245472 | Completed

• 1 other identifier: HandanCentral
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder-hand Syndrome

Keywords

Shoulder-hand syndrome; Dry Needling; Kinesio Taping; Myofascial Trigger Points

Outcome Measures

Primary Outcomes (2)

• Pain Intensity

  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.

  Baseline, 14 days, and 28 days post-treatment.

• Upper Limb Motor Function

  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.

  Baseline, 14 days, and 28 days post-treatment.

Secondary Outcomes (3)

• 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.

Study Arms (3)

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

EXPERIMENTAL

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.

Device: Dry Needling; Device: Sham Kinesio taping

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

EXPERIMENTAL

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.

Device: Kinesio Taping; Device: Sham Dry Needling

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

EXPERIMENTAL

Participants received both active DN and KT interventions

Device: Dry Needling; Device: Kinesio Taping

Interventions

Dry Needling 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.

Group A (n = 28) received DN and sham Kinesio taping; Group C (n = 28) was treated with KT combined with DN.

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

Kinesio Taping 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 B (n = 28) was treated with KT and sham DN; Group C (n = 28) was treated with KT combined with DN.

Sham Dry Needling 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.

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

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Handan Central Hospital: lead

Study Sites (1)

Handan Central Hospital

Handan, Hebei, 057150, China

Location

MeSH Terms

Conditions

Reflex Sympathetic Dystrophy

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Complex Regional Pain Syndromes; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: November 24, 2025
• Study Start: November 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 24, 2025

Record last verified: 2025-09

Locations

CN (1)