Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of this study is to determine whether transforaminal dexamethasone injections are effective in the treatment of chronic Hemiplegic Shoulder Pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 3, 2012
CompletedFirst Posted
Study publicly available on registry
April 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedApril 6, 2012
March 1, 2012
7 months
April 3, 2012
April 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Algometry in shoulder muscles
1 week and 3 months after treatment
Study Arms (2)
Sham
SHAM COMPARATORSham arm received a simulation of transforaminal injection using a non-penetrating needle
Transforaminal
EXPERIMENTALSubjects received TF with infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml
Interventions
Subjects received transforaminal infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml
Eligibility Criteria
You may qualify if:
- 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
- to 65 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of São Paulo General Hospital
São Paulo, São Paulo, 05408040, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joao D Amadera, MD
University of São Paulo General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2012
First Posted
April 6, 2012
Study Start
October 1, 2011
Primary Completion
May 1, 2012
Study Completion
November 1, 2012
Last Updated
April 6, 2012
Record last verified: 2012-03