Shoulder PainPhase 2SSNBNCT00732589
SSNB in Hemiplegic Shoulder Pain
A Phase 2 study testing 1% xylocaine and ultrasound in people with Shoulder Pain and Stroke, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The purpose of this study is to compare suprascapular nerve block with therapeutic ultrasound in stroke patients who have shoulder pain in weak side. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Shoulder Pain, Stroke
- What is being tested?
- 1% xylocaine and ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2008to May 2009
- Phase
- Phase 2
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stroke patients who develope shoulder pain at weak limb.
- Good conscious and able to access pain score.
- No history of drug reaction with xylocaine
- No history of fracture,tumor or blood tendency.
- Willing to enrolled to study and signs inform consent.
Who cannot join
- Patients who do not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of physical medicine and rehabilitation, Faculty of medicien, Chulalongkorn University
Bangkok, Bangkok
About this study
Official title: Suprascapular Nerve Block in Hemiplegic Shoulder Pain.
The purpose of this study is to compare suprascapular nerve block with therapeutic ultrasound in stroke patients who have shoulder pain in weak side.
Read the detailed description
Shoulder pain is a common complication after a cerebrovascular accident.Hemiplegic shoulder pain has been shown to affect stroke outcome in a negative way.It interferes with recovery after stroke:it can cause distress and reduced activities and can markedly hinder rehabilitation.Suprascapular nerve block has been shown to be effective as an analgesic for different indications such as shoulder capsulitis.The purpose of this study was to evaluate the effectiveness of this technique conjunction with a rehabilitation program to reduce shoulder pain in hemiplegic patients.
- Conditions
- Shoulder Pain, Stroke
- Being tested
- 1% xylocaine, ultrasound
- Keywords
- suprascapular nerve block, shoulder pain, hemiplegia
- Medical subject headings
- Shoulder Pain, Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% xylocaineDrug
Also called suprascapular nerve block
10 cc. of 1%xylocaine, once a week
ultrasoundOther
Also called therapeutic ultrasound
ultrasound at shoulder area about 10 mins.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Suprascapular nerve block Receives: Drug: 1% xylocaine |
| B | Experimental | therapeutic ultrasound Receives: Other: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score of pain
Measured: 4 weeks after intervention
Secondary outcomes (1)
Range of motion of the shoulder joint
Measured: 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Investigators
- Jariya Boonhong, physiatist, Principal investigator, Unaffiliation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732589
- Sponsor's protocol ID
- Chulalongkorn University
- Acronym
- SSNB
- Status last verified
- Aug 2008
- First submitted
- 8 Aug 2008
- Last updated
- 18 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprascapular Nerve Block in Hemiplegic Shoulder Pain.
- ClinicalTrials.gov ID
- NCT00732589
- Acronym / sponsor ID
- SSNB / Chulalongkorn University
- Conditions
- Shoulder Pain, Stroke
- Keywords
- suprascapular nerve block, shoulder pain, hemiplegia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 0 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 12 Aug 2008 (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.
The purpose of this study is to compare suprascapular nerve block with therapeutic ultrasound in stroke patients who have shoulder pain in weak side.
Detailed description
Shoulder pain is a common complication after a cerebrovascular accident.Hemiplegic shoulder pain has been shown to affect stroke outcome in a negative way.It interferes with recovery after stroke:it can cause distress and reduced activities and can markedly hinder rehabilitation.Suprascapular nerve block has been shown to be effective as an analgesic for different indications such as shoulder capsulitis.The purpose of this study was to evaluate the effectiveness of this technique conjunction with a rehabilitation program to reduce shoulder pain in hemiplegic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: 1% xylocaineSuprascapular nerve block |
| B | Experimental | Other: ultrasoundtherapeutic ultrasound |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Stroke patients who develope shoulder pain at weak limb.
- Good conscious and able to access pain score.
- No history of drug reaction with xylocaine
- No history of fracture,tumor or blood tendency.
- Willing to enrolled to study and signs inform consent.
Key exclusion criteria (1 listed)
- Patients who do not meet the inclusion criteria.
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 |
|---|---|---|
| 1% xylocaineAlso: suprascapular nerve block10 cc. of 1%xylocaine, once a week | Drug | A |
| ultrasoundAlso: therapeutic ultrasoundultrasound at shoulder area about 10 mins. | Other | B |
Primary outcome
VAS score of pain
Time frame: 4 weeks after intervention
1 secondary outcome
Range of motion of the shoulder joint
Time frame: 4 weeks after 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 18 Nov 2009.
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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.
Jariya Boonhong, physiatist principal investigator
Unaffiliation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1% xylocaine and ultrasound in people with Shoulder Pain and Stroke, run by Chulalongkorn University at 1 site in Thailand.
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 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 18 Nov 2009. 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 Thailand. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
VAS score of pain (time frame: 4 weeks after 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 18 Nov 2009.