Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain
|ClinicalTrials.gov Identifier: NCT01572285|
Recruitment Status : Unknown
Verified March 2012 by University of Sao Paulo General Hospital.
Recruitment status was: Recruiting
First Posted : April 6, 2012
Last Update Posted : April 6, 2012
|Condition or disease||Intervention/treatment|
|Hemiplegic Shoulder Pain||Procedure: transforaminal dexamethasone injection Procedure: Sham|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain : A Randomized, Sham-Controlled, Proof of Principle Trial|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||November 2012|
Sham Comparator: Sham
Sham arm received a simulation of transforaminal injection using a non-penetrating needle
Sham procedure using a non-penetrating needle
Subjects received TF with infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml
Procedure: transforaminal dexamethasone injection
Subjects received transforaminal infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml
- 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).
- Algometry in shoulder muscles [ Time Frame: 1 week and 3 months after treatment ]Algometry were measured in all shoulder muscles.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572285
|Contact: Joao D Amadera, MD||55 11 firstname.lastname@example.org|
|University of São Paulo General Hospital||Recruiting|
|São Paulo, SP, Brazil, 05408040|
|Contact: Joao D Amadera, MD 55 11 92692069 email@example.com|
|Principal Investigator: Joao D Amadera, MD|
|Principal Investigator:||Joao D Amadera, MD||University of São Paulo General Hospital|