Shoulder-hand SyndromePhase 2/3NCT02011854
Acupuncture for Post-stroke Shoulder-hand Syndrome
A Phase 2/3 study testing rehabilitation and Acupuncture in people with Shoulder-hand Syndrome, run by Zouqin Huang at 1 site in China.
Trial summary
Shoulder-hand syndrome，a common complication of stroke patient，which is an important factor of limb function recovery.This research aims to observe the effect and safety of Acupuncture and Traditional Chinese medicine Combined with Rehabilitation Therapy for Post-stroke Shoulder-hand Syndrome.Furthermore, the… 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?
- rehabilitation and Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Oct 2016
- Phase
- Phase 2/3
- 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
- Ischemic stroke and shoulder hand syndrome,conscious,For 2 weeks to 6 months,Patients with I or Ⅱ period.
Who cannot join
- Disturbance of consciousness,With shoulder joint disease or muscle disease,Patients with shoulder hand syndrome Ⅲ period,Serious primary diseases such as heart,liver and kidney,Mental illness.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Pudong New Area TCM Hospital
Shanghai, Shanghai Municipality, 201299
Huang Zouqin, Doctor, 021-58989669/2727, hzqmusic@yeah.net
Huang Zouqin, 13564599607
About this study
Official title: Acupuncture and Traditional Chinese Medicine Combined With Rehabilitation Therapy for Post-stroke Shoulder-hand Syndrome in Community Hospital: a Multicenter，Randomized，Controlled Trial
Shoulder-hand syndrome，a common complication of stroke patient，which is an important factor of limb function recovery.This research aims to observe the effect and safety of Acupuncture and Traditional Chinese medicine Combined with Rehabilitation Therapy for Post-stroke Shoulder-hand Syndrome.Furthermore, the investigators will promote the treatment in community hospital.
- Conditions
- Shoulder-hand Syndrome
- Being tested
- rehabilitation, Acupuncture
- Keywords
- acupuncture，rehabilitation,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.
rehabilitationDevice
rehabilitation,To treat five times a week,Total course is eight weeks
AcupunctureDevice
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture with rehabilitation | Experimental | Electric acupuncture,Chinese medicine,Chinese medicine cupping,rehabilitation,To treat five times a week,Total course is eight weeks Receives: Device: rehabilitation; Device: Acupuncture |
| rehabilitation | Other | rehabilitation,To treat five times a week,Total course is eight weeks Receives: Device: rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS) method Visual analogue scale (VAS) method Visual analogue scale (VAS)
To evaluate the pain in shoulder joint
Measured: 4 weeks and 8 weeks after treatment
Secondary outcomes (1)
Fugl-Meyer scale
To evaluate the limb movement function
Measured: 4 weeks and 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zouqin Huang
- Sponsor type
- University, hospital or other
- Collaborators
- Longhua Hospital
- Responsible party
- Sponsor-investigator, Zouqin Huang, Shanghai University of Traditional Chinese Medicine
- Investigators
- Huang Zouqin, Dcctor, Study director, Pudong New Area TCM Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011854
- Sponsor's protocol ID
- PW2013A-41
- Status last verified
- Dec 2013
- First submitted
- 10 Dec 2013
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture and Traditional Chinese Medicine Combined With Rehabilitation Therapy for Post-stroke Shoulder-hand Syndrome in Community Hospital: a Multicenter，Randomized，Controlled Trial
- ClinicalTrials.gov ID
- NCT02011854
- Acronym / sponsor ID
- PW2013A-41
- Conditions
- Shoulder-hand Syndrome
- Keywords
- acupuncture，rehabilitation,Shoulder-hand Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zouqin HuangUniversity, hospital or other
- Collaborators
- Longhua Hospital
- Study start
- Oct 2013
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 13 Dec 2013 (estimated)
- 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.
Shoulder-hand syndrome，a common complication of stroke patient，which is an important factor of limb function recovery.This research aims to observe the effect and safety of Acupuncture and Traditional Chinese medicine Combined with Rehabilitation Therapy for Post-stroke Shoulder-hand Syndrome.Furthermore, the investigators will promote the treatment in community hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture with rehabilitation | Experimental | Device: rehabilitation, Device: AcupunctureElectric acupuncture,Chinese medicine,Chinese medicine cupping,rehabilitation,To treat five times a week,Total course is eight weeks |
| rehabilitation | Other | Device: rehabilitationrehabilitation,To treat five times a week,Total course is eight weeks |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ischemic stroke and shoulder hand syndrome,conscious,For 2 weeks to 6 months,Patients with I or Ⅱ period.
Key exclusion criteria (1 listed)
- Disturbance of consciousness,With shoulder joint disease or muscle disease,Patients with shoulder hand syndrome Ⅲ period,Serious primary diseases such as heart,liver and kidney,Mental illness.
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 |
|---|---|---|
| rehabilitationrehabilitation,To treat five times a week,Total course is eight weeks | Device | Acupuncture with rehabilitation, rehabilitation |
| Acupuncture | Device | Acupuncture with rehabilitation |
Primary outcome
Visual analogue scale (VAS) method Visual analogue scale (VAS) method Visual analogue scale (VAS)
Time frame: 4 weeks and 8 weeks after treatment
To evaluate the pain in shoulder joint
1 secondary outcome
Fugl-Meyer scale
Time frame: 4 weeks and 8 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
Related trials for Shoulder-hand Syndrome
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Shoulder Impingement Syndrome
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Core Stability vs Scapular Stabilization on Hand Grip Strength in Chronic Myofascial Neck Pain
Myofascial Neck Pain, Hand Grip Strength
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Effects of Task-Based Mirror Therapy for Post-stroke Shoulder-Hand Syndrome
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.
Huang Zouqin, Dcctor study director
Pudong New Area TCM Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing rehabilitation and Acupuncture in people with Shoulder-hand Syndrome, run by Zouqin Huang 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Dec 2013. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact huang Zouqin, Dr. (021-58989669/2727, hzqmusic@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) method Visual analogue scale (VAS) method Visual analogue scale (VAS) (time frame: 4 weeks and 8 weeks after treatment). 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 13 Dec 2013.