Cryolesion in Treatment of Phantom Limb Pain

NCT03415360 | Unknown

• 1 other identifier: 681006-6
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cryoablation

Outcome Measures

Primary Outcomes (1)

• Reduction of pain

  Assessment of pain intensity pre- and post - cryoablation on the NRS (numeric rating scale). Numeric Rating Scale (NRS) is a unidimensional measure of pain intensity in adults. This is a 11-point numeric scale ranges from '0' (minimum, "no pain") to '10' (maximum, "pain as bad as one can imagine"). The lower the NRS value, the better clinical outcome.

  T1: before cryoablation; T2: 24 hours after cryoablation; T3: 7 days after cryoablation; T4: 30 days after cryoablation; T5: 3 months after cryoablation; T6: 6 months after cryoablation.

Secondary Outcomes (2)

• The quality of life (SF-36)

  A1: before cryoablation; A2: 24 hours after cryoablation; A3: 30 days after cryoablation; A4: 6 months after cryoablation.

• The quality of life (AIS)

  A1: before cryoablation; A2: 24 hours after cryoablation; A3: 30 days after cryoablation; A4: 6 months after cryoablation.

Study Arms (1)

cryoablation

OTHER

peripheral nerve cryoablation

Procedure: cryoablation

Interventions

cryoablation PROCEDURE

cryoablation of nerve responsible for phantom limb pain

cryoablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Status post amputation of a lower or upper limb
• Pain related to amputation as determined by referring physician and investigator
• Informed consent of patient to enter the study
• Reduction of pain after the diagnostic/prognostic anesthetic block of the relevant main peripheral nerves under ultrasonography guidance in an analogous fashion to the cryoablation procedure

You may not qualify if:

• Pregnancy
• Active infection in the area of the planned intervention
• Blood coagulation disorders
• Immunosuppression
• Significant spinal stenosis or spinal anomalies that result in differential nerve root pressures
• Significant disease or disorder that in the opinion of the Principal Investigator would preclude the safe performance of the anesthetic block or cryoablation
• Participation in another investigational trial involving systemic administration of agents of unknown chemical composition.
• No reduction of pain after the diagnostic block of the relevant main peripheral nerves

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead

Study Sites (1)

Military Institute of Medicine

Warsaw, 04141, Poland

RECRUITING

MeSH Terms

Conditions

Phantom Limb; Neuralgia

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Dariusz Tomaszewski

  Military Institute of Medicine

  STUDY CHAIR

Central Study Contacts

Dariusz Tomaszewski, MD PhD

CONTACT

00 48501 190 386; dtomaszewski@wim.mil.pl

Jaroslaw J Les, MD PhD

CONTACT

00 48 695 926 026; jles@wim.mil.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct professor

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: January 13, 2018
• First Posted: January 30, 2018
• Study Start: February 9, 2018
• Primary Completion: June 1, 2019
• Study Completion: January 1, 2020
• Last Updated: September 25, 2018

Record last verified: 2018-09

Locations

PL (1)