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The purpose of this study is to determine whether transforaminal dexamethasone injections are effective in the treatment of chronic Hemiplegic Shoulder Pain.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham | Sham Comparator | Sham arm received a simulation of transforaminal injection using a non-penetrating needle |
|
| Transforaminal | Experimental | Subjects received TF with infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transforaminal dexamethasone injection | Procedure | Subjects received transforaminal infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 week and 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Algometry in shoulder muscles | Algometry were measured in all shoulder muscles. | 1 week and 3 months after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joao D Amadera, MD | Contact | 55 11 92692069 | joao@fmusp.org.br |
| Name | Affiliation | Role |
|---|---|---|
| Joao D Amadera, MD | University of São Paulo General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of São Paulo General Hospital | Recruiting | São Paulo | São Paulo | 05408040 | Brazil |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D013256 | Steroids |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D000072473 | Fused-Ring Compounds |
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|
| Sham | Procedure | Sham procedure using a non-penetrating needle |
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |