Temperature Increase by Lumbar Sympathetic Ganglion Block with Botulinum toxin type A

Temperature Increase by Lumbar Sympathetic Ganglion Block with Botulinum toxin type A: A Prospective Randomized, double-blind, and Comparative Clinical Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003569

Enrollment

Registered

2019-02-28

Start date

2018-12-10

Completion date

Unknown

Last updated

2022-11-28

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

Conditions

None listed

Interventions

Drug : Patients were assigned 1: 1 to a control group using only local anesthetics (Group A) and a BTX-A group (Group B). In the control group, for LSB in Phase 1, two needles are inserted near the ve

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) aged 19-85 years; (2) 11-point numerical-rating-scale (NRS) pain score of 4 or higher in lower extremity (3) Diagnosed with a complex regional pain syndrome (type 1 or 2) or post traumatic pain syndrome (4) More than 1.5 ? temperature increase at diagnostic block in 2 times trial with 1.5ml of local anesthetics.

Exclusion criteria

Exclusion criteria: (1) Refusal of the patient (2) Vascular disease at lower extremity (ex, thromboangitis obliterans) (3) previous lumbar sympathetic neurolysis (thermocoagulation, chemical neurolysis) (4) coagulopathy (5) systemic infection or local infection at lumbar puncture site (6) significant deformity at lumbar spine (7) neoplasm (8) known allergic reaction with amide type local anesthetics (9) cognitive dysfunction (not understanding of numerical-rating-scale) (10) known allergic reaction with botulinum toxin (11) pregnant or feeding women (12) If the patient has participated in another clinical trial within 30 days before screening, or if passed no longer than 5-fold half-life of the clinical trial drug of the participating clinical trial

Design outcomes

Primary

Measure	Time frame
the change in the relative temperature difference on the blocked sole compared with the contralateral sole	—

Secondary

Measure	Time frame
Temperature change in group A vs B at ipsilateral and contralateral leg;success rate;Korean CISS (Cold Intolerance Symptom Severity) Questionnaire;NRS pain score change;pain related with procedure;Medication change;5-pointed satisfaction scale;Blood flow velosity at popliteal artery using ultrasound;Maintenance of temperature change in group A vs B at ipsilateral leg	—

Countries

Korea, Republic of

Contacts

Public ContactJee Youn Moon

Seoul National University Hospital

jymoon0901@gmail.com+82-2-2072-2467

Outcome results