Hemiplegic Shoulder PainNCT05085236
Fu's Subcutaneous Needling Treatment for Hemiplegic Shoulder Pain
A study testing Fu's subcutaneous needling (FSN) and Rehabilitation in people with Hemiplegic Shoulder Pain, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The post-stroke survivors suffered from shoulder pain are very common. The investigators performed Fu's subcutaneous needling (FSN). This experiment used a randomized controlled trial to assess the immediate, short-term and long-term effects of Fu's subcutaneous needling therapy on hemiplegic shoulder pain in patient… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hemiplegic Shoulder Pain
- What is being tested?
- Fu's subcutaneous needling (FSN) and Rehabilitation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Nov 2021to 6 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Volunteers who are older than 40 years old suffered from first stroke attack including infarction and hemorrhage with image proved and can cooperate with the experiment.
- 2. Stroke patient suffered from shoulder pain.
- 3. Patient can follow the directions of Fu's subcutaneous needling and regular rehabilitation program.
Who cannot join
- 1. There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant and lactated women.
- 2. There has been a history of drug abuse (including excess alcohol) that affects pain assessment.
- 3. Cognitive impairment, unable to cooperate with the experiment.
- 4. Aphasia
- 5. Have received shoulder joint injection in recent 6 months.
- 6. Have serious skin infection, laceration, wound and trauma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Effect of Fu's Subcutaneous Needling for Recovery Outcomes of Stroke Survivors With Hemiplegic Shoulder Pain.: Randomized-controlled Trial
The post-stroke survivors suffered from shoulder pain are very common. The investigators performed Fu's subcutaneous needling (FSN). This experiment used a randomized controlled trial to assess the immediate, short-term and long-term effects of Fu's subcutaneous needling therapy on hemiplegic shoulder pain in patient with stroke.
Read the detailed description
The prevalence of complication in post-stroke survivors is 30-96%. Post-stroke pain is the most common complication. According to previous researches there are sixty percent post-stroke survivors who suffered from upper limb pain. The mechanism causes post-stroke shoulder pain is imbalance of shoulder muscles and in-coordination of shoulder motor control due to cerebral vascular disease. Post-stroke shoulder pain often causes the limitation of shoulder range of motion, and the pain always affected quality of life and daily activities. Because of shoulder pain, those post-stroke survivors postponed the program of rehabilitation. The treatments of post-stroke shoulder pain are transcutaneous electrical nerve stimulation, drug, intra-articular injection and nerve block. Acupuncture with combination of rehabilitation has been proved by many researches in alleviating pain and increasing quality of life in treating post-stroke shoulder pain. Fu's subcutaneous needling is a newly technique based on meridian theory and the technique is used to treat cervical, lumbar and four limb's pain proved by many researches. Fu's subcutaneous needling in managing post-stroke pain has less reported, so investigator set up a proposal to see if the Fu's subcutaneous needling could elevate more therapeutic effect compared to usual care or not.
The investigators will enroll patients into two groups, experimental and control groups. The interventions in experimental group are Fu's subcutaneous needling in combination with rehabilitation, and in control group is rehabilitation. The trial will extend two weeks, and investigator will treat with Fu's subcutaneous needling three times in the first, second and fourth day when the patients include to our trial. The outcome measurements are visual analog scale, range of motion of shoulder, pressure pain threshold of myofascial trigger point, acromion-greater tuberosity distance, Fugl-Meyer assessment in upper extremity and functional independence measure.
- Conditions
- Hemiplegic Shoulder Pain
- Being tested
- Fu's subcutaneous needling (FSN), Rehabilitation
- Keywords
- Fu's subcutaneous needling, post-stroke complications, post-stroke shoulder pain, hemiplegic shoulder pain, shoulder hand syndrome
- 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.
Fu's subcutaneous needling (FSN)Procedure or surgery
physician will use a disposable Fu's subcutaneous needling (FSN) to penetrate the subject's skin in the middle from elbow lateral epicondyle to radial styloid process. Then physician will push forward the needle parallel to the skin surface. the physician will sway the needle 100 times in a minute. After procedure of swaying needle, the physician will instruct subject to do several movements, and each movement will perform 10 seconds and rest 10 seconds for 3 repetitions. The movements are active isometric elbow flexion, active isometric shoulder internal rotation, passive shoulder external and internal rotation. After above re-perfusion approach of muscles, the physician will take out the needle to finish the treatment.
RehabilitationProcedure or surgery
Rehabilitation mentioned here is the regular rehabilitation programs for treating post-stroke hemiplegic shoulder pain prescribed by the rehabilitation physician.
| Study group | Role | What they receive |
|---|---|---|
| Fu's subcutaneous needling (FSN) in combination with rehabilitation | Experimental | In this arm, the subjects will receive the intervention of FSN combined with regular rehabilitation program on Day1, Day2, and Day4, in total 3 treatments. The subjects will receive assessments before and after each interventions. After total treatments finishing, the subjects will receive assessments on Day8 and Day15. Receives: Procedure: Fu's subcutaneous needling (FSN); Procedure: Rehabilitation |
| Rehabilitation | Active comparator | In this arm, the subjects will receive the intervention of regular rehabilitation program prescribed by physician of rehabilitation. On Day1, Day2, and Day4, the subjects will receive assessments before and after each interventions. After total treatments finishing, the subjects will receive assessments on Day8 and Day15. Receives: Procedure: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
A Visual Analog Scale consists of a line, often 10 cm long, with verbal anchors at either end, on left of line, zero, meant no pain otherwise on right, 10, meant strong pain. The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity.
Measured: 1 day
Pressure Pain Threshold
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom
Measured: 1 day
Range of Motion of Shoulder
Range of Motion is the measurement of movement around a specific joint, measured in degrees of a circle. In this study we measure shoulder joint, glenohumeral joint, in flexion, extension, external and internal rotation.
Measured: 1 day
Acromion-GreaterTuberosity Distance
In this study we assess of shoulder joint subluxation by means of ultrasound measurement of Acromion-greater tuberosity distance.
Measured: 1 day
Fugl-Meyer assessment in upper extremity
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. In upper extremity, we measure motor function included shoulder, elbow, wrist and hand, and assess coordination using finger to nose.
Measured: 1 day
Functional Independence Measure
The Functional Independence Measure (FIM) is an instrument that was developed as a measure of disability. Includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start26 Nov 2021
- Primary completion6 Sep 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Shoulder PainStudies of the same condition, open and under way.
- More trials run by China Medical University 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Wei Chou, PhD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085236
- Sponsor's protocol ID
- CMUH110-REC2-124
- Status last verified
- Aug 2024
- First submitted
- 7 Oct 2021
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Fu's Subcutaneous Needling for Recovery Outcomes of Stroke Survivors With Hemiplegic Shoulder Pain.: Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT05085236
- Acronym / sponsor ID
- CMUH110-REC2-124
- Conditions
- Hemiplegic Shoulder Pain
- Keywords
- Fu's subcutaneous needling, post-stroke complications, post-stroke shoulder pain, hemiplegic shoulder pain, shoulder hand syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 20 Oct 2021 (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 post-stroke survivors suffered from shoulder pain are very common. The investigators performed Fu's subcutaneous needling (FSN). This experiment used a randomized controlled trial to assess the immediate, short-term and long-term effects of Fu's subcutaneous needling therapy on hemiplegic shoulder pain in patient with stroke.
Detailed description
The prevalence of complication in post-stroke survivors is 30-96%. Post-stroke pain is the most common complication. According to previous researches there are sixty percent post-stroke survivors who suffered from upper limb pain. The mechanism causes post-stroke shoulder pain is imbalance of shoulder muscles and in-coordination of shoulder motor control due to cerebral vascular disease. Post-stroke shoulder pain often causes the limitation of shoulder range of motion, and the pain always affected quality of life and daily activities. Because of shoulder pain, those post-stroke survivors postponed the program of rehabilitation. The treatments of post-stroke shoulder pain are transcutaneous electrical nerve stimulation, drug, intra-articular injection and nerve block. Acupuncture with combination of rehabilitation has been proved by many researches in alleviating pain and increasing quality of life in treating post-stroke shoulder pain. Fu's subcutaneous needling is a newly technique based on meridian theory and the technique is used to treat cervical, lumbar and four limb's pain proved by many researches. Fu's subcutaneous needling in managing post-stroke pain has less reported, so investigator set up a proposal to see if the Fu's subcutaneous needling could elevate more therapeutic effect compared to usual care or not.
The investigators will enroll patients into two groups, experimental and control groups. The interventions in experimental group are Fu's subcutaneous needling in combination with rehabilitation, and in control group is rehabilitation. The trial will extend two weeks, and investigator will treat with Fu's subcutaneous needling three times in the first, second and fourth day when the patients include to our trial. The outcome measurements are visual analog scale, range of motion of shoulder, pressure pain threshold of myofascial trigger point, acromion-greater tuberosity distance, Fugl-Meyer assessment in upper extremity and functional independence measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fu's subcutaneous needling (FSN) in combination with rehabilitation | Experimental | Procedure: Fu's subcutaneous needling (FSN), Procedure: RehabilitationIn this arm, the subjects will receive the intervention of FSN combined with regular rehabilitation program on Day1, Day2, and Day4, in total 3 treatments. The subjects will receive assessments before and after each interventions. After total treatments finishing, the subjects will receive assessments on Day8 and Day15. |
| Rehabilitation | Active comparator | Procedure: RehabilitationIn this arm, the subjects will receive the intervention of regular rehabilitation program prescribed by physician of rehabilitation. On Day1, Day2, and Day4, the subjects will receive assessments before and after each interventions. After total treatments finishing, the subjects will receive assessments on Day8 and Day15. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Volunteers who are older than 40 years old suffered from first stroke attack including infarction and hemorrhage with image proved and can cooperate with the experiment.
- 2. Stroke patient suffered from shoulder pain.
- 3. Patient can follow the directions of Fu's subcutaneous needling and regular rehabilitation program.
Key exclusion criteria (6 listed)
- 1. There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant and lactated women.
- 2. There has been a history of drug abuse (including excess alcohol) that affects pain assessment.
- 3. Cognitive impairment, unable to cooperate with the experiment.
- 4. Aphasia
- 5. Have received shoulder joint injection in recent 6 months.
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 |
|---|---|---|
| Fu's subcutaneous needling (FSN)physician will use a disposable Fu's subcutaneous needling (FSN) to penetrate the subject's skin in the middle from elbow lateral epicondyle to radial styloid process. Then physician will push forward the needle parallel to the skin surface. the physician will sway the needle 100 times in a minute. After procedure of swaying needle, the physician will instruct subject to do several movements, and each movement will perform 10 seconds and rest 10 seconds for 3 repetitions. The movements are active isometric elbow flexion, active isometric shoulder internal rotation, passive shoulder external and internal rotation. After above re-perfusion approach of muscles, the physician will take out the needle to finish the treatment. | Procedure or surgery | Fu's subcutaneous needling (FSN) in combination with rehabilitation |
| RehabilitationRehabilitation mentioned here is the regular rehabilitation programs for treating post-stroke hemiplegic shoulder pain prescribed by the rehabilitation physician. | Procedure or surgery | Fu's subcutaneous needling (FSN) in combination with rehabilitation, Rehabilitation |
Primary outcome
Visual Analog Scale
Time frame: 1 day
A Visual Analog Scale consists of a line, often 10 cm long, with verbal anchors at either end, on left of line, zero, meant no pain otherwise on right, 10, meant strong pain. The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity.
Pressure Pain Threshold
Time frame: 1 day
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom
Range of Motion of Shoulder
Time frame: 1 day
Range of Motion is the measurement of movement around a specific joint, measured in degrees of a circle. In this study we measure shoulder joint, glenohumeral joint, in flexion, extension, external and internal rotation.
Acromion-GreaterTuberosity Distance
Time frame: 1 day
In this study we assess of shoulder joint subluxation by means of ultrasound measurement of Acromion-greater tuberosity distance.
Fugl-Meyer assessment in upper extremity
Time frame: 1 day
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. In upper extremity, we measure motor function included shoulder, elbow, wrist and hand, and assess coordination using finger to nose.
Functional Independence Measure
Time frame: 1 day
The Functional Independence Measure (FIM) is an instrument that was developed as a measure of disability. Includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition.
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 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Stroke
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.
Li-Wei Chou, PhD principal investigator
China Medical University 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 Fu's subcutaneous needling (FSN) and Rehabilitation in people with Hemiplegic Shoulder Pain, run by China Medical University 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 6 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 Apr 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 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. 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?
Visual Analog Scale (time frame: 1 day). The study lists 6 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 Apr 2025.