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

University of Sao Paulo

Status and phase: Unknown; Phase 3

Conditions: Complex Regional Pain Syndrome I of Upper Limb

Treatments: Procedure: thoracic sympathetic block

Study type: Interventional

Funder types: Other

Identifiers

NCT01612364

5138 - 1805142/1

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups

thoracic sympathetic block

Experimental group

Description:

Sympathetic block of upper limb via thoracic vertebra T3

Treatment:

Procedure: thoracic sympathetic block

control block

Active Comparator group

Description:

Same medication used in experimental group, but in dorsal subcutaneous

Treatment:

Procedure: thoracic sympathetic block