MedTrace Logo

Cryolesion in Treatment of Phantom Limb Pain

NCT03415360 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-09-25

No results posted yet for this study

Summary

Assessment of pain intensity on the NRS. Assessment of the quality of life by SF-36 and AIS. Diagnostic/prognostic nerve block with 5 ml of 2% lidocaine under real-time ultrasound control with confirmation of the correct position of the needle using a peripheral nerve stimulator.

Reassessment of pain intensity on the NRS 30 minutes after local anesthetic block.

Cryoablation under real-time ultrasound control if the NRS value is reduced by ≥ 2 points.

If pain intensity on the NRS reduced by less than 2 points, reassessment 60 minutes after local anesthetic block.

Cryoablation under real-time ultrasound control if the NRS value is reduced by ≥ 2 points.

If pain intensity on the NRS reduces by less than 2 points 60 minutes after local anesthetic block cryoablation will not be performed.

Cryoablation effect will be evaluated 24 hours, 7 days, 30 days, 3 months, 6 months post procedure.

* 24 hours after the procedure - assessment of pain intensity and quality of life
* 7 days after the procedure - assessment of pain intensity
* 30 days after the procedure - assessment of pain intensity and quality of life
* 3 months after the procedure - assessment of pain intensity
* 6 months after the procedure - assessment of pain intensity and quality of

Conditions

  • Phantom Limb Pain
  • Stump Neuralgia
  • Pain, Phantom

Interventions

PROCEDURE

cryoablation

cryoablation of nerve responsible for phantom limb pain

Sponsors & Collaborators

  • Military Institute od Medicine National Research Institute

    lead OTHER

Principal Investigators

  • Dariusz Tomaszewski · Military Institute of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-09
Primary Completion
2019-06-30
Completion
2020-01-31

Countries

  • Poland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03415360 on ClinicalTrials.gov