Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Sao Paulo General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01572285
First received: April 3, 2012
Last updated: April 5, 2012
Last verified: March 2012

April 3, 2012
April 5, 2012
October 2011
May 2012   (final data collection date for primary outcome measure)
Pain improvement after transforaminal injection using the Visual Analogue Scale (VAS) [ Time Frame: 1 week and 3 months after treatment ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01572285 on ClinicalTrials.gov Archive Site
Algometry in shoulder muscles [ Time Frame: 1 week and 3 months after treatment ] [ Designated as safety issue: No ]
Algometry were measured in all shoulder muscles.
Same as current
Not Provided
Not Provided
 
Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hemiplegic Shoulder Pain
  • Procedure: transforaminal dexamethasone injection
    Subjects received transforaminal infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml
    Other Names:
    • dexamethasone
    • steroid
    • transforaminal
    • TF
    • TFESI
  • Procedure: Sham
    Sham procedure using a non-penetrating needle
  • Sham Comparator: Sham
    Sham arm received a simulation of transforaminal injection using a non-penetrating needle
    Intervention: Procedure: Sham
  • Experimental: Transforaminal
    Subjects received TF with infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml
    Intervention: Procedure: transforaminal dexamethasone injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
November 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
50 Years to 65 Years
No
Contact: Joao D Amadera, MD 55 11 92692069 joao@fmusp.org.br
Brazil
 
NCT01572285
0530/09
Yes
University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
Not Provided
Principal Investigator: Joao D Amadera, MD University of São Paulo General Hospital
University of Sao Paulo General Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP