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

Double-Blind Randomized Controlled Trial: Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01612364

Enrollment

Registered

2012-06-05

Start date

2010-01-31

Completion date

2013-11-30

Last updated

2012-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Regional Pain Syndrome I of Upper Limb

Keywords

CRPS I

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).

Interventions

PROCEDUREthoracic sympathetic block

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%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Analgesia after block	1 month	Analgesia (Mcgill, brief pain inventary, DN4 questionaire, VAS) and functional (ADM) evaluation.

Secondary

Measure	Time frame
analgesia quality of life	1 year

Countries

Brazil

Contacts

Primary ContactRoberto O Rocha, MD

contato@drrobertorocha.com.br551182668553

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026