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RCT :Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb

Primary Purpose

Complex Regional Pain Syndrome I of Upper Limb

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
thoracic sympathetic block
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndrome I of Upper Limb focused on measuring CRPS I

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Complex regional pain syndrome (IASP, 1994) involving an upper limb;
  • Pain scores in excess of five visual analog scale (VAS);
  • Poor outcome to treatment (less than 50% reduction in VAS scores) -

Exclusion Criteria:

  • History of severe brain injury, epilepsy and stroke
  • Patients who had undergone sympathetic ganglion block for treatment of the affected limb, by any technique
  • Severe systemic disease
  • Addictive behavior, severe psychiatric disorders, psychiatric diseases untreated
  • Refusal to participate or not initial adherence to orientations
  • Refusal to be randomized in a treatment group or with contraindications to any of them pregnancy.

Sites / Locations

  • Hospital das Clinicas, Faculty of Medicine, University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

thoracic sympathetic block

control block

Arm Description

Sympathetic block of upper limb via thoracic vertebra T3

Same medication used in experimental group, but in dorsal subcutaneous

Outcomes

Primary Outcome Measures

Analgesia after block
Analgesia (Mcgill, brief pain inventary, DN4 questionaire, VAS) and functional (ADM) evaluation.

Secondary Outcome Measures

analgesia quality of life

Full Information

First Posted
May 30, 2012
Last Updated
June 1, 2012
Sponsor
University of Sao Paulo
Collaborators
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01612364
Brief Title
RCT :Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb
Official Title
Double-Blind Randomized Controlled Trial: Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
November 2013 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a double-blind randomized controlled trial to evaluate the efficacy of the sympathetic block via thoracic vertebra T3 for the treatment of CRPS I upper limb. Patients with CRPS I refractory to medical treatment will be subjected to four physical therapy sessions and then the randomized for experimental or control block and then more four physiotherapy sessions. Patients will be evaluated after one month of the blockade (primary outcome) and then up to 12 months. Will be evaluated by analgesic scale (Mcgill, brief pain inventory, dn4 questionnaire, NPSI, VAS), functional (ADM) and quality of life (HAD and WHOQOL-brief).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndrome I of Upper Limb
Keywords
CRPS I

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
thoracic sympathetic block
Arm Type
Experimental
Arm Description
Sympathetic block of upper limb via thoracic vertebra T3
Arm Title
control block
Arm Type
Active Comparator
Arm Description
Same medication used in experimental group, but in dorsal subcutaneous
Intervention Type
Procedure
Intervention Name(s)
thoracic sympathetic block
Other Intervention Name(s)
T2-T3 thoracic sympathetic block, T3 sympathetic block, T2-T3 thoracic dorsal sympathetic block, thoracic sympathetic ganglion block
Intervention Description
Thoracic sympathetic block is sympathetic block of upper limb described by Leriche e Fontaine em 1925. The block is performed under radioscopic view, positioning the needle lateral the body of thoracic vertebra T3, where infuse anesthetic solution. The theoretical advantage over the stellate ganglion is its greater specificity and efficiency. Solution block: 5ml ropivacaine 0,75% + 5ml de triamcinolone 2%
Primary Outcome Measure Information:
Title
Analgesia after block
Description
Analgesia (Mcgill, brief pain inventary, DN4 questionaire, VAS) and functional (ADM) evaluation.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
analgesia quality of life
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Complex regional pain syndrome (IASP, 1994) involving an upper limb; Pain scores in excess of five visual analog scale (VAS); Poor outcome to treatment (less than 50% reduction in VAS scores) - Exclusion Criteria: History of severe brain injury, epilepsy and stroke Patients who had undergone sympathetic ganglion block for treatment of the affected limb, by any technique Severe systemic disease Addictive behavior, severe psychiatric disorders, psychiatric diseases untreated Refusal to participate or not initial adherence to orientations Refusal to be randomized in a treatment group or with contraindications to any of them pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto O Rocha, MD
Phone
551182668553
Email
contato@drrobertorocha.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto O Rocha, MD
Organizational Affiliation
Hospital das Clinicas Faculty of Medicine University Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto O Rocha, MD
Phone
5511 82668553
Email
contato@drrobertorocha.com.br
First Name & Middle Initial & Last Name & Degree
Roberto O Rocha, MD

12. IPD Sharing Statement

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RCT :Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb

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