Cryolesion in Treatment of Phantom Limb Pain

Percutaneous Cryoablation in the Treatment of Neuropathic Pain Post Limb Amputation

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

Study Overview

• Status: Unknown
• Conditions: Phantom Limb Pain; Pain, Phantom; Stump Neuralgia
• Intervention / Treatment: Procedure: cryoablation

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dariusz Tomaszewski, MD PhD; Phone Number: 00 48501 190 386; Email: dtomaszewski@wim.mil.pl
• Study Contact Backup: Name: Jaroslaw J Les, MD PhD; Phone Number: 00 48 695 926 026; Email: jles@wim.mil.pl

Study Locations

• Poland
  • Warsaw, Poland, 04141
    • Recruiting
    • Military Institute of Medicine
    • Contact: Jaroslaw Les, MD, PhD; Phone Number: +48 216816895; Email: jles@wim.mil.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: cryoablation; peripheral nerve cryoablation	Procedure: cryoablation; cryoablation of nerve responsible for phantom limb pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The quality of life (SF-36)	Assessment of the quality of life pre- and post - cryoablation on SF-36. 36-Item Short Form Survey (SF-36) is a 36-item questionnaire which measures quality of life across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. For each of the eight domains that the SF36 measures an aggregate percentage score is produced. The percentage scores range from 0% (lowest or worst possible level of functioning) to 100% (highest or best possible level of functioning).	A1: before cryoablation; A2: 24 hours after cryoablation; A3: 30 days after cryoablation; A4: 6 months after cryoablation.
The quality of life (AIS)	Assessment of the quality of life pre- and post - cryoablation on AIS. The Acceptance of Illness Scale (AIS) consists of eight statements describing negative impact of poor health status and its consequences for patients' functioning. The scoring for each statement varies from 1 (poor adaptation to the disease) to 5 (full acceptance of the disease). The total score ranges between 8 and 40. The lower score, the poorer acceptance of disease and more severe restrictions caused by condition. A high score means acceptance of patient's own health status and lack of negative emotions related to illness.	A1: before cryoablation; A2: 24 hours after cryoablation; A3: 30 days after cryoablation; A4: 6 months after cryoablation.

Collaborators and Investigators

• Sponsor: Military Institute of Medicine, Poland
• Investigators: Study Chair: Dariusz Tomaszewski, Military Institute of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: January 13, 2018
• First Submitted That Met QC Criteria: January 29, 2018
• First Posted (Actual): January 30, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2018
• Last Update Submitted That Met QC Criteria: September 21, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: cryoablation
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Perceptual Disorders; Pain, Postoperative; Neuralgia; Phantom Limb
• Other Study ID Numbers: 681006-6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No