Shoulder Pain in Hemiplegic Side After StrokeNCT01650207
Acupuncture for Hemiplegic Shoulder Pain
A study testing acupuncture and TENS in people with Shoulder Pain in Hemiplegic Side After Stroke, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
Shoulder pain has been reported to be one of the most common complications after stroke. Several factors have been related to shoulder pain after stroke such as paralysis, restricted range of motion in the shoulder, spasticity, sensory abnormalities, but the relationship between these factors and pain was not… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain in Hemiplegic Side After Stroke
- What is being tested?
- acupuncture and TENS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2011to Jun 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke within 6 months from onset
- Hemiplegia with shoulder pain (VAS > 2)
Who cannot join
- previous pathology of the shoulder or cardiac pacemaker, and cognition problems
Trial locations and contacts
1 site in 1 country.
About this study
Shoulder pain has been reported to be one of the most common complications after stroke. Several factors have been related to shoulder pain after stroke such as paralysis, restricted range of motion in the shoulder, spasticity, sensory abnormalities, but the relationship between these factors and pain was not discussed.
The aim of this study is to identify the efficacy of electroacupuncture in reducing upper limbs spasticity and shoulder pain in stroke patients, and to evaluate the quality of life (QOL) for stroke patients.
- Being tested
- acupuncture, TENS, sham acupuncture
- Keywords
- electroacupuncture, TENS, shoulder disorder, hemiplegia
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
All participants were received regular rehabilitation program, and received different interventions.
treatment frequency: 20 minutes per session, once daily, 5 times a week for 2 weeks
TENSProcedure or surgery
sham acupunctureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| EA group | Experimental | To acupuncture the Juanyu (Li15) \& Jugu (Li16) with sensation of de-qi, and then give 50 Hz electrical stimulation for 20 minutes. Receives: Procedure: acupuncture |
| TENS group | Experimental | The electrical patches were placed on the Juanyu (Li15) \& Jugu (Li16) or Juanyu (Li15), Quchi (Li11), Shousanli (Li10) \& Hegu (Li4), connected to a TENS apparatus and then give 50 Hz electrical stimulation for 20 minutes. Receives: Procedure: TENS |
| sham-acupuncutre | Sham comparator | The Park's Sham Device were placed on the Juanyu (Li15) \& Jugu (Li16). Receives: Procedure: sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
shoulder pain degrees
pain VAS in passive shoulder ROM
Measured: 10 days after first intervention
Secondary outcomes (1)
shoulder ROM
passive shoulder ROM (abduction, ER)
Measured: 10 days after first intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startJul 2011
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Pain in Hemiplegic Side After StrokeStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ta-Sen Wei,MD, Changhua Christian Hospital
- Investigators
- Tasen Wei, Principal investigator, Physical Medical and Rehabilitation, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650207
- Sponsor's protocol ID
- CCH-110410
- Status last verified
- Jul 2012
- First submitted
- 12 Jul 2012
- Last updated
- 26 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Hemiplegic Shoulder Pain
- ClinicalTrials.gov ID
- NCT01650207
- Acronym / sponsor ID
- CCH-110410
- Keywords
- electroacupuncture, TENS, shoulder disorder, hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 26 Jul 2012 (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 pain has been reported to be one of the most common complications after stroke. Several factors have been related to shoulder pain after stroke such as paralysis, restricted range of motion in the shoulder, spasticity, sensory abnormalities, but the relationship between these factors and pain was not discussed.
The aim of this study is to identify the efficacy of electroacupuncture in reducing upper limbs spasticity and shoulder pain in stroke patients, and to evaluate the quality of life (QOL) for stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EA group | Experimental | Procedure: acupunctureTo acupuncture the Juanyu (Li15) \& Jugu (Li16) with sensation of de-qi, and then give 50 Hz electrical stimulation for 20 minutes. |
| TENS group | Experimental | Procedure: TENSThe electrical patches were placed on the Juanyu (Li15) \& Jugu (Li16) or Juanyu (Li15), Quchi (Li11), Shousanli (Li10) \& Hegu (Li4), connected to a TENS apparatus and then give 50 Hz electrical stimulation for 20 minutes. |
| sham-acupuncutre | Sham comparator | Procedure: sham acupunctureThe Park's Sham Device were placed on the Juanyu (Li15) \& Jugu (Li16). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stroke within 6 months from onset
- Hemiplegia with shoulder pain (VAS > 2)
Key exclusion criteria (1 listed)
- previous pathology of the shoulder or cardiac pacemaker, and cognition problems
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 |
|---|---|---|
| acupunctureAll participants were received regular rehabilitation program, and received different interventions. treatment frequency: 20 minutes per session, once daily, 5 times a week for 2 weeks | Procedure or surgery | EA group |
| TENS | Procedure or surgery | TENS group |
| sham acupuncture | Procedure or surgery | sham-acupuncutre |
Primary outcome
shoulder pain degrees
Time frame: 10 days after first intervention
pain VAS in passive shoulder ROM
1 secondary outcome
shoulder ROM
Time frame: 10 days after first intervention
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 26 Jul 2012.
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.
Tasen Wei principal investigator
Physical Medical and Rehabilitation, Changhua Christian 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 acupuncture and TENS in people with Shoulder Pain in Hemiplegic Side After Stroke, run by Changhua Christian 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 2 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: finished, as of the sponsor's last update on 26 Jul 2012. 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?
shoulder pain degrees (time frame: 10 days after first intervention). 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 26 Jul 2012.