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Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain

Primary Purpose

Hemiplegic Shoulder Pain

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
transforaminal dexamethasone injection
Sham
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegic Shoulder Pain focused on measuring Hemiplegic, Shoulder Pain, Transforaminal, Treatment, Interventional

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of São Paulo General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham

Transforaminal

Arm Description

Sham arm received a simulation of transforaminal injection using a non-penetrating needle

Subjects received TF with infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Algometry in shoulder muscles
Algometry were measured in all shoulder muscles.

Full Information

First Posted
April 3, 2012
Last Updated
April 5, 2012
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01572285
Brief Title
Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain
Official Title
Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain : A Randomized, Sham-Controlled, Proof of Principle Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Shoulder Pain
Keywords
Hemiplegic, Shoulder Pain, Transforaminal, Treatment, Interventional

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Sham arm received a simulation of transforaminal injection using a non-penetrating needle
Arm Title
Transforaminal
Arm Type
Experimental
Arm Description
Subjects received TF with infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml
Intervention Type
Procedure
Intervention Name(s)
transforaminal dexamethasone injection
Other Intervention Name(s)
dexamethasone, steroid, transforaminal, TF, TFESI
Intervention Description
Subjects received transforaminal infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml
Intervention Type
Procedure
Intervention Name(s)
Sham
Intervention Description
Sham procedure using a non-penetrating needle
Primary Outcome Measure Information:
Title
Pain improvement after transforaminal injection using the Visual Analogue Scale (VAS)
Description
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).
Time Frame
1 week and 3 months after treatment
Secondary Outcome Measure Information:
Title
Algometry in shoulder muscles
Description
Algometry were measured in all shoulder muscles.
Time Frame
1 week and 3 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joao D Amadera, MD
Phone
55 11 92692069
Email
joao@fmusp.org.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joao D Amadera, MD
Organizational Affiliation
University of São Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of São Paulo General Hospital
City
São Paulo
State/Province
SP
ZIP/Postal Code
05408040
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joao D Amadera, MD
Phone
55 11 92692069
Email
joao@fmusp.org.br
First Name & Middle Initial & Last Name & Degree
Joao D Amadera, MD

12. IPD Sharing Statement

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Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain

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