StrokeNCT05395325
Clinical Effects of Combined Kinesiotaping and Steroid Injection in Stroke Patients With Hemiplegic Shoulder Pain
A study testing Kinesiotaping, Hand rehabilitation program and Steroid injection in people with Stroke and Hemiplegic Shoulder Pain, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The aims of this study is to investigate sono-guided shoulder steroid injection combined with Kinesiotaping applications in reducing shoulder pain, improving functional performance on upper extremity and quality of life in stroke patients with hemiplegic shoulder pain. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke, Hemiplegic Shoulder Pain
- What is being tested?
- Kinesiotaping, Hand rehabilitation program and Steroid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 May 2022to 31 Aug 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients have a stroke with hemiplegia (duration is less than 6 months after stroke).
- The patients complain about shoulder pain and there're soft tissue impairment under sonography measurement.
- Patients who are able to perform slightly hand grasp( at least 10 degrees at metacarpophalangeal and interphalangeal joints).
Who cannot join
- age is younger than 20 years old or older than 80 years old
- previous history of upper extremity tendon or neuromuscular injury, shoulder pain, frozen shoulder or shoulder surgery before stroke,
- any other systemic neuromuscular disease; cognition or language impairment leading to communication difficulty.
- allergic to kinesio tape
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Kaohsiung, 833
About this study
Official title: The Clinical Effects of Combined Kinesiotaping and Steroid Injection in Stroke Patients With Hemiplegic Shoulder Pain : A Randomized Controlled Trial
The aims of this study is to investigate sono-guided shoulder steroid injection combined with Kinesiotaping applications in reducing shoulder pain, improving functional performance on upper extremity and quality of life in stroke patients with hemiplegic shoulder pain.
Read the detailed description
Hemiplegic shoulder pain is one of the most common complications in stroke patients, and it has negative effects on rehabilitation in hemiplegic side, functional recovery of upper extremity, and quality of life. The common treatments for hemiplegic shoulder pain include oral medication,transcutaneous electrical nerve stimulation, and local injections. Steroid or sodium hyaluronate are mainly used in local injections. Steroid can suppress inflammation and immune system effectively.
Furthermore, the clinical characteristics of impaired motor performance on affected limb in stroke patients include muscle weakness, increased muscle tone, contracture, joint instability, or impaired of motor control. Impaired motor performance of upper extremity and spasticity have negative impacts in functional performances and daily activities. In stroke patients with poststroke spasticity, stretching, range of motion exercises, antispasticity splint, neuromuscular electrical stimulation, oral medications and local injection of botulinum toxin are recommended. Some investigators found that Kinesiotaping (KT) combined with other interventions may facilitate muscle function, provide joint support and proprioception feedback, and reduce pain in stroke patients with hemiplegia. Thus, the investigators will perform steroid injection in stroke patients with hemiplegic shoulder pain to reduce pain, and apply KT while receiving rehabilitation to facilitate motor recovery and functional performance in affected upper extremity.
In this study, 50 stroke patients with hemiplegic shoulder pain will be recruited and randomly divided into experimental and control groups. In experimental group(n=25), the patients will receive KT combined steroid injection with rehabilitation, and the injection will perform only one time in the entire intervention period. In control group, the patients will receive KT with rehabilitation. In both groups, KT will be applied for three weeks. All participants will receive shoulder sonography evaluation before intervention to investigate the condition of hemiplegic shoulder pain and receive physical examination, hand function assessment before intervention, after the three-week intervention and three-week post intervention.
The aims of this study is to investigate sono-guided shoulder steroid injection combined with Kinesiotaping applications in reducing shoulder pain, improving functional performance on upper extremity and quality of life in stroke patients with hemiplegic shoulder pain.
- Conditions
- Stroke, Hemiplegic Shoulder Pain
- Being tested
- Kinesiotaping, Hand rehabilitation program, Steroid injection
- Keywords
- hemiplegic shoulder pain, Kinesiotaping, Stroke, steroid injection
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingOther
Kinesio tape would be applied (1)over the extensor muscles of the affected hand for facilitating the extension of hand. We will apply the tape from the upper 1/3 length of dorsal side of the forearm and split the tape into five equal bars to the distal interphalangeal joint of each finger along the finger bones. (2) from above the scapula spine to the medial deltoid. (3) from medial border of scapula to anterior deltoid.This intervention would be executed for five days per week for three weeks.
Hand rehabilitation programOther
In the thirty-minute hand rehabilitation program, a motor-relearning theory would be implemented into the intervention by teaching the participants how to use their upper limb properly without any compensatory motions. Therefore, for establishing a correct movement pattern, an occupational therapist would provide a hand-guided activity, in which the participants could practice reaching movement as well as hand grasp and release in a more natural way. Besides, the therapist would also help the patients release their muscle tone by stretching the spastic muscles for five minutes before and after this hand rehabilitation period
Steroid injectionOther
all the steroid injection would be executed by physicians. The 23G needles would be used for the injections. The examiners would be clear and familiar with the protocol, and the injections would be executed for only one time during the study period in experimental group.
| Study group | Role | What they receive |
|---|---|---|
| KT and steroid injection group | Experimental | the patients will receive steroid injection for only one time before intervention, and receive KT for 5 days a week, for three weeks. And a 30-minute hand functional training would also be provided once daily every day during the intervention. Receives: Other: Kinesiotaping; Other: Hand rehabilitation program; Other: Steroid injection |
| KT group | Sham comparator | the patients will receive KT for 5 days a week, for three weeks. And a 30-minute hand functional training would also be provided once daily every day during the intervention. Receives: Other: Kinesiotaping; Other: Hand rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change from baseline to time of Fugl-Meyer assessment for upper extremity
a therapist will evaluate Fugl-Meyer assessment for upper extremity (FMA-UE) for each participant. In this assessment, participants would need to execute a series of movements, which involved proximal and distal part of upper limb. The higher the grade, the better the performance. The total score ranges from 0 to 66 for motor function.
Measured: 4th week, and 7th week
the change from baseline to time of Flexilevel Scale of Shoulder Function
Flexilevel Scale of Shoulder Function(FLEX-SF) would be used to measure the shoulder performance in daily activities.It is a self-reported questionnaire. The higher the grade, the better the performance.
Measured: 4th week, and 7th week
Secondary outcomes (9)
the change from baseline to time of Brunnstrom stage
a therapist will measure motor recovery stage (Brunnstrom stage)
Measured: 4th week, and 7th week
the change from baseline to time of quality of life by Stroke Impact Scale
Stroke Impact Scale would be used to measure the independence of daily activities. It is a self-reported questionnaire. The contents involve various aspect of life. The high the grade, the more serious the life is affected. The total score is from 0 to 100 for self-assessing the level of recovery.
Measured: 4th week, and 7th week
the change from baseline to time of quality of life by Barthel Index
Barthel Index would be used to measure the independence of daily activities. It is a form that contains different activities of daily living. The higher the outcome grades, the better the level of independence.
Measured: 4th week, and 7th week
the change from baseline to time of functional performance by box and block test
box and block test would be used to assess the grasping and release performance of the affected hand.
Measured: 4th week, and 7th week
the change from baseline to time of functional performance by STEF
Simple Test for Evaluating Hand Function (STEF) would be used to assess the hand function by executing various types of grasping.
Measured: 4th week, and 7th week
the change from baseline to time of VAS
Visual Analog Scale (VAS) would be used to assess the self-reported shoulder pain level of patients. The score ranges from 0 to 10. The higher the grades, the worst pain the patients experienced.
Measured: 4th week, and 7th week
the change from baseline to time of PROM
a therapist will measure passive range of motions of shoulder joint.
Measured: 4th week, and 7th week
the change from baseline to time of edema
a therapist will measure forearm, wrist and middle palm circumference to assess edema.
Measured: 4th week, and 7th week
the change from baseline to time of MAS scale
a therapist will measure spasticity of affected upper extremity at elbow and wrist joints (modified Ashworth scale). In this scale, muscle tone would be assessed by quick stretch of muscle belly. The scoring criteria are as follows. 0, no increase in muscle tone; 1, Slight increase in muscle tone; 2, More marked increase in muscle tone through most of the ROM; 3, considerable increase in muscle tone; 4, affected part(s) rigid in flexion or extension.
Measured: 4th week, and 7th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start5 May 2022
- Primary completion31 Jul 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuchi Huang, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395325
- Sponsor's protocol ID
- CMRPG8M0431
- Status last verified
- Jun 2025
- First submitted
- 24 May 2022
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effects of Combined Kinesiotaping and Steroid Injection in Stroke Patients With Hemiplegic Shoulder Pain : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05395325
- Acronym / sponsor ID
- CMRPG8M0431
- Conditions
- Stroke, Hemiplegic Shoulder Pain
- Keywords
- hemiplegic shoulder pain, Kinesiotaping, Stroke, steroid injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 27 May 2022 (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 aims of this study is to investigate sono-guided shoulder steroid injection combined with Kinesiotaping applications in reducing shoulder pain, improving functional performance on upper extremity and quality of life in stroke patients with hemiplegic shoulder pain.
Detailed description
Hemiplegic shoulder pain is one of the most common complications in stroke patients, and it has negative effects on rehabilitation in hemiplegic side, functional recovery of upper extremity, and quality of life. The common treatments for hemiplegic shoulder pain include oral medication,transcutaneous electrical nerve stimulation, and local injections. Steroid or sodium hyaluronate are mainly used in local injections. Steroid can suppress inflammation and immune system effectively.
Furthermore, the clinical characteristics of impaired motor performance on affected limb in stroke patients include muscle weakness, increased muscle tone, contracture, joint instability, or impaired of motor control. Impaired motor performance of upper extremity and spasticity have negative impacts in functional performances and daily activities. In stroke patients with poststroke spasticity, stretching, range of motion exercises, antispasticity splint, neuromuscular electrical stimulation, oral medications and local injection of botulinum toxin are recommended. Some investigators found that Kinesiotaping (KT) combined with other interventions may facilitate muscle function, provide joint support and proprioception feedback, and reduce pain in stroke patients with hemiplegia. Thus, the investigators will perform steroid injection in stroke patients with hemiplegic shoulder pain to reduce pain, and apply KT while receiving rehabilitation to facilitate motor recovery and functional performance in affected upper extremity.
In this study, 50 stroke patients with hemiplegic shoulder pain will be recruited and randomly divided into experimental and control groups. In experimental group(n=25), the patients will receive KT combined steroid injection with rehabilitation, and the injection will perform only one time in the entire intervention period. In control group, the patients will receive KT with rehabilitation. In both groups, KT will be applied for three weeks. All participants will receive shoulder sonography evaluation before intervention to investigate the condition of hemiplegic shoulder pain and receive physical examination, hand function assessment before intervention, after the three-week intervention and three-week post intervention.
The aims of this study is to investigate sono-guided shoulder steroid injection combined with Kinesiotaping applications in reducing shoulder pain, improving functional performance on upper extremity and quality of life in stroke patients with hemiplegic shoulder pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KT and steroid injection group | Experimental | Other: Kinesiotaping, Other: Hand rehabilitation program, Other: Steroid injectionthe patients will receive steroid injection for only one time before intervention, and receive KT for 5 days a week, for three weeks. And a 30-minute hand functional training would also be provided once daily every day during the intervention. |
| KT group | Sham comparator | Other: Kinesiotaping, Other: Hand rehabilitation programthe patients will receive KT for 5 days a week, for three weeks. And a 30-minute hand functional training would also be provided once daily every day during the intervention. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patients have a stroke with hemiplegia (duration is less than 6 months after stroke).
- The patients complain about shoulder pain and there're soft tissue impairment under sonography measurement.
- Patients who are able to perform slightly hand grasp( at least 10 degrees at metacarpophalangeal and interphalangeal joints).
Key exclusion criteria (4 listed)
- age is younger than 20 years old or older than 80 years old
- previous history of upper extremity tendon or neuromuscular injury, shoulder pain, frozen shoulder or shoulder surgery before stroke,
- any other systemic neuromuscular disease; cognition or language impairment leading to communication difficulty.
- allergic to kinesio tape
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 |
|---|---|---|
| KinesiotapingKinesio tape would be applied (1)over the extensor muscles of the affected hand for facilitating the extension of hand. We will apply the tape from the upper 1/3 length of dorsal side of the forearm and split the tape into five equal bars to the distal interphalangeal joint of each finger along the finger bones. (2) from above the scapula spine to the medial deltoid. (3) from medial border of scapula to anterior deltoid.This intervention would be executed for five days per week for three weeks. | Other | KT and steroid injection group, KT group |
| Hand rehabilitation programIn the thirty-minute hand rehabilitation program, a motor-relearning theory would be implemented into the intervention by teaching the participants how to use their upper limb properly without any compensatory motions. Therefore, for establishing a correct movement pattern, an occupational therapist would provide a hand-guided activity, in which the participants could practice reaching movement as well as hand grasp and release in a more natural way. Besides, the therapist would also help the patients release their muscle tone by stretching the spastic muscles for five minutes before and after this hand rehabilitation period | Other | KT and steroid injection group, KT group |
| Steroid injectionall the steroid injection would be executed by physicians. The 23G needles would be used for the injections. The examiners would be clear and familiar with the protocol, and the injections would be executed for only one time during the study period in experimental group. | Other | KT and steroid injection group |
Primary outcome
the change from baseline to time of Fugl-Meyer assessment for upper extremity
Time frame: 4th week, and 7th week
a therapist will evaluate Fugl-Meyer assessment for upper extremity (FMA-UE) for each participant. In this assessment, participants would need to execute a series of movements, which involved proximal and distal part of upper limb. The higher the grade, the better the performance. The total score ranges from 0 to 66 for motor function.
the change from baseline to time of Flexilevel Scale of Shoulder Function
Time frame: 4th week, and 7th week
Flexilevel Scale of Shoulder Function(FLEX-SF) would be used to measure the shoulder performance in daily activities.It is a self-reported questionnaire. The higher the grade, the better the performance.
9 secondary outcomes
the change from baseline to time of Brunnstrom stage
Time frame: 4th week, and 7th week
the change from baseline to time of quality of life by Stroke Impact Scale
Time frame: 4th week, and 7th week
the change from baseline to time of quality of life by Barthel Index
Time frame: 4th week, and 7th week
the change from baseline to time of functional performance by box and block test
Time frame: 4th week, and 7th week
the change from baseline to time of functional performance by STEF
Time frame: 4th week, and 7th week
the change from baseline to time of VAS
Time frame: 4th week, and 7th week
the change from baseline to time of PROM
Time frame: 4th week, and 7th week
the change from baseline to time of edema
Time frame: 4th week, and 7th week
the change from baseline to time of MAS scale
Time frame: 4th week, and 7th week
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 5 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Yuchi Huang study chair
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotaping, Hand rehabilitation program and Steroid injection in people with Stroke and Hemiplegic Shoulder Pain, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 4 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 5 Aug 2026. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
the change from baseline to time of Fugl-Meyer assessment for upper extremity (time frame: 4th week, and 7th week). 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 5 Aug 2026.