Hemiplegic Shoulder PainNCT01572285
Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain
A study testing transforaminal dexamethasone injection in people with Hemiplegic Shoulder Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether transforaminal dexamethasone injections are effective in the treatment of chronic Hemiplegic Shoulder Pain. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Hemiplegic Shoulder Pain
- What is being tested?
- transforaminal dexamethasone injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2011to Nov 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 3 months of shoulder pain following a stroke
- hemiplegia or paresis after a cerebral stroke for at least 6 months
- Shoulder pain greater than 4 in a visual analogue scale
- 50 to 65 years old
Who cannot join
- inability to understand or answer the tools in the study
- local inflammation or infection
- History of malignancy
- use of cardiac pacemaker
- allergy to lidocaine or dexamethasone
- disorders of coagulation
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of São Paulo General Hospital
São Paulo, São Paulo, 05408040
Joao D Amadera, MD, 55 11 92692069, joao@fmusp.org.br
Joao D Amadera, MD
About this study
Official title: Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain : A Randomized, Sham-Controlled, Proof of Principle Trial
The purpose of this study is to determine whether transforaminal dexamethasone injections are effective in the treatment of chronic Hemiplegic Shoulder Pain.
Read the detailed description
Shoulder pain is the most common complication in hemiplegia after Stroke (CVA). Almost three quarters of all patients with hemiplegia will suffer from shoulder pain in the first twelve months after stroke. Because of the lack of effective treatment today, the optimal management of hemiplegic shoulder pain is prevention. Although widely studied, all clinical trials for shoulder pain in stroke fail to show efficacy. TF was never investigated to treat Hemiplegic Shoulder Pain (HSP). The investigators hypothesize that injecting the epidural space at the C6 level via transforaminal would desensitize both central medullary components of pain as peripheral sensitized structures such as the suprascapular nerve of the affected shoulder.
To test this hypothesis, the investigators developed a treatment protocol consisting of two C6 transforaminal epidural steroid injection with dexamethasone (TF with 0.5mL of lidocaine 1% and 1.5mL of Dexamethasone 10mg/ml). This procedure was compared to a sham intervention.
- Conditions
- Hemiplegic Shoulder Pain
- Being tested
- transforaminal dexamethasone injection, Sham
- Keywords
- Hemiplegic, Shoulder Pain, Transforaminal, Treatment, Interventional
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transforaminal dexamethasone injectionProcedure or surgery
Also called dexamethasone, steroid, transforaminal, TF
Subjects received transforaminal infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml
ShamProcedure or surgery
Sham procedure using a non-penetrating needle
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Sham arm received a simulation of transforaminal injection using a non-penetrating needle Receives: Procedure: Sham |
| Transforaminal | Experimental | Subjects received TF with infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml Receives: Procedure: transforaminal dexamethasone injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain improvement after transforaminal injection using the Visual Analogue Scale (VAS)
The primary outcome measures were pain measured using a visual analogue scale (VAS on a scale of 0≈10cm; where 0=no pain and 10=highest pain level during the last week).
Measured: 1 week and 3 months after treatment
Secondary outcomes (1)
Algometry in shoulder muscles
Algometry were measured in all shoulder muscles.
Measured: 1 week and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startOct 2011
- Primary completionMay 2012 (estimated)
- Study completionNov 2012 (estimated)
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 University of Sao Paulo General 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joao D Amadera, MD, Principal investigator, University of São Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572285
- Sponsor's protocol ID
- 0530/09
- Status last verified
- Mar 2012
- First submitted
- 3 Apr 2012
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain : A Randomized, Sham-Controlled, Proof of Principle Trial
- ClinicalTrials.gov ID
- NCT01572285
- Acronym / sponsor ID
- 0530/09
- Conditions
- Hemiplegic Shoulder Pain
- Keywords
- Hemiplegic, Shoulder Pain, Transforaminal, Treatment, Interventional
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 6 Apr 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.
The purpose of this study is to determine whether transforaminal dexamethasone injections are effective in the treatment of chronic Hemiplegic Shoulder Pain.
Detailed description
Shoulder pain is the most common complication in hemiplegia after Stroke (CVA). Almost three quarters of all patients with hemiplegia will suffer from shoulder pain in the first twelve months after stroke. Because of the lack of effective treatment today, the optimal management of hemiplegic shoulder pain is prevention. Although widely studied, all clinical trials for shoulder pain in stroke fail to show efficacy. TF was never investigated to treat Hemiplegic Shoulder Pain (HSP). The investigators hypothesize that injecting the epidural space at the C6 level via transforaminal would desensitize both central medullary components of pain as peripheral sensitized structures such as the suprascapular nerve of the affected shoulder.
To test this hypothesis, the investigators developed a treatment protocol consisting of two C6 transforaminal epidural steroid injection with dexamethasone (TF with 0.5mL of lidocaine 1% and 1.5mL of Dexamethasone 10mg/ml). This procedure was compared to a sham intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Procedure: ShamSham arm received a simulation of transforaminal injection using a non-penetrating needle |
| Transforaminal | Experimental | Procedure: transforaminal dexamethasone injectionSubjects received TF with infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 3 months of shoulder pain following a stroke
- hemiplegia or paresis after a cerebral stroke for at least 6 months
- Shoulder pain greater than 4 in a visual analogue scale
- 50 to 65 years old
Key exclusion criteria (6 listed)
- inability to understand or answer the tools in the study
- local inflammation or infection
- History of malignancy
- use of cardiac pacemaker
- allergy to lidocaine or dexamethasone
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 |
|---|---|---|
| transforaminal dexamethasone injectionAlso: dexamethasone, steroid, transforaminal, TFSubjects received transforaminal infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml | Procedure or surgery | Transforaminal |
| ShamSham procedure using a non-penetrating needle | Procedure or surgery | Sham |
Primary outcome
Pain improvement after transforaminal injection using the Visual Analogue Scale (VAS)
Time frame: 1 week and 3 months after treatment
The primary outcome measures were pain measured using a visual analogue scale (VAS on a scale of 0≈10cm; where 0=no pain and 10=highest pain level during the last week).
1 secondary outcome
Algometry in shoulder muscles
Time frame: 1 week and 3 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
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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.
Joao D Amadera, MD principal investigator
University of São Paulo General 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 transforaminal dexamethasone injection in people with Hemiplegic Shoulder Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 4 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: status not confirmed, as of the sponsor's last update on 6 Apr 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joao D Amadera, MD (55 11 92692069, joao@fmusp.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain improvement after transforaminal injection using the Visual Analogue Scale (VAS) (time frame: 1 week and 3 months 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 6 Apr 2012.