Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain : A Randomized, Sham-Controlled, Proof of Principle Trial

Conditions
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Hemiplegic Shoulder Pain

Intervention / Treatment
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* Procedure: transforaminal dexamethasone injection
* Procedure: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham<br>Sham arm received a simulation of transforaminal injection using a non-penetrating needle | Procedure: Sham<br>* Sham procedure using a non-penetrating needle<br>|
| Experimental: Transforaminal<br>Subjects received TF with infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml | Procedure: transforaminal dexamethasone injection<br>* Subjects received transforaminal infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml<br>* Other names: TFESI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Algometry in shoulder muscles | Algometry were measured in all shoulder muscles. | 1 week and 3 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemiplegic, Shoulder Pain, Transforaminal, Treatment, Interventional