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Thermovision-controlled Lumbar Sympathetic Blockade in Chronic Limb-threatening Ischemia Treatment

ConditionChronic Limb-Threatening Ischemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorEPC Education s.r.o.

About this trial

Thermovision-controlled lumbar sympathetic blockade in chronic limb-threatening ischemia treatment

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Chronic limb-threatening ischemia-Patients with chronic leg pain for at least 6 months with intensity (VAS >=5)

those who (only if a signature was obtainable), or whose legal guardian,fully understood the clinical trial -details and signed the informed consent form

Disqualifiers

Chronic Venous Insufficiency

women with positive a pregnancy tests before the trial or who planned to become pregnant within the following 3 years

other patients viewed as inappropriate by the staff

disagreement with participation in the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • lumbar sympathetic blockade

    Procedure/Surgery

    Skiascopic-guided lumbar sympathetic blockade with the administration of local anesthetic

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention
Group C: Group CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 3m

EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression

Time frame
3 months follow-up
2

Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 6m

EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression

Time frame
6 months follow-up
3

Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 3m

Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 3m measured by VAS 10 point measurement

Time frame
3 months follow-up
4

Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m

Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m measured by VAS 10 point measurement

Time frame
6 months follow-up

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EPC Education s.r.o.

Lead sponsor

Slovak Academy of Sciences

Collaborator

Source ClinicalTrials.gov
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