Shoulder-hand SyndromeNCT07245472
The Treatment of Shoulder-hand Syndrome in Hemiplegia Patients
A study testing Dry Needling and Kinesio Taping in people with Shoulder-hand Syndrome, run by Handan Central Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Shoulder-hand Syndrome
- What is being tested?
- Dry Needling and Kinesio Taping
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effect of Kinesio Taping Combined With Dry Needling to Myofascial Trigger Point on Shoulder-hand Syndrome in Hemiplegia Patients
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.
Read the 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
- Being tested
- Dry Needling, Sham Kinesio taping, Kinesio Taping, Sham Dry Needling
- Keywords
- Shoulder-hand syndrome, Dry Needling, Kinesio Taping, Myofascial Trigger Points
- Medical subject headings
- Reflex Sympathetic Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingDevice
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 tapingDevice
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.
Kinesio TapingDevice
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.
Sham Dry NeedlingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Device: Dry Needling; Device: Kinesio Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 14 days, and 28 days post-treatment.
Secondary outcomes (3)
Degree of Finger Edema
Finger swelling was evaluated by measuring the difference in the "8-figure" circumference between the affected and healthy hands. The measurement started from the ulnar styloid process, parallel to the wrist crease, passed around the dorsum of the hand across the fifth and second metacarpophalangeal joints, diagonally crossed the back of the hand, and returned to the starting point.
Measured: Baseline, 14 days, and 28 days post-treatment.
Passive Range of Motion of the Shoulder Joint
Passive range of motion of the shoulder joint was measured using a standard goniometer. Assessment indicators included passive flexion, extension, abduction, adduction, horizontal abduction, horizontal adduction, horizontal medial rotation, and horizontal lateral rotation .
Measured: Baseline, 14 days, and 28 days post-treatment.
Activities of Daily Living
The Activities of Daily Living scale was used for assessment. This scale includes 10 aspects: eating, personal hygiene, bathing, toileting, dressing, anal control, bladder control, bed-chair transfer, level walking, and stair climbing, with a total score of 100 points . A score >60 indicates that the patient can independently perform activities of daily living, with higher scores indicating better living ability.
Measured: Baseline, 14 days, and 28 days post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Nov 2023
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder-hand SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Handan Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245472
- Sponsor's protocol ID
- HandanCentral
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect of Kinesio Taping Combined With Dry Needling to Myofascial Trigger Point on Shoulder-hand Syndrome in Hemiplegia Patients
- ClinicalTrials.gov ID
- NCT07245472
- Acronym / sponsor ID
- HandanCentral
- Conditions
- Shoulder-hand Syndrome
- Keywords
- Shoulder-hand syndrome, Dry Needling, Kinesio Taping, Myofascial Trigger Points
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Handan Central HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (n = 28) received DN and sham Kinesio taping | Experimental | Device: Dry Needling, Device: Sham Kinesio tapingAn 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 B (n = 28) was treated with KT and sham DN | Experimental | Device: Kinesio Taping, Device: Sham Dry NeedlingParticipants 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 C (n = 28) was treated with KT combined with DN. | Experimental | Device: Dry Needling, Device: Kinesio TapingParticipants received both active DN and KT interventions |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry NeedlingThe 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 | Group A (n = 28) received DN and sham Kinesio taping, Group C (n = 28) was treated with KT combined with DN. |
| Sham Kinesio tapingFor 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 | Group A (n = 28) received DN and sham Kinesio taping |
| Kinesio TapingPatients 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 | Group B (n = 28) was treated with KT and sham DN, Group C (n = 28) was treated with KT combined with DN. |
| Sham Dry NeedlingFor 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. | Device | Group B (n = 28) was treated with KT and sham DN |
Primary outcome
Pain Intensity
Time frame: 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
Time frame: 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.
3 secondary outcomes
Degree of Finger Edema
Time frame: Baseline, 14 days, and 28 days post-treatment.
Passive Range of Motion of the Shoulder Joint
Time frame: Baseline, 14 days, and 28 days post-treatment.
Activities of Daily Living
Time frame: Baseline, 14 days, and 28 days post-treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling and Kinesio Taping in people with Shoulder-hand Syndrome, run by Handan Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Baseline, 14 days, and 28 days post-treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.