Cryoablation for Post Mastectomy Pain Syndrome

Percutaneous Image Guided Cryoablation of the Intercostobrachial Nerve for Management of Post Mastectomy Pain Syndrome

This is a prospective, randomized, parallel-group, treatment control trial with cross-over options performed at four sites. The purpose of this study is to assess the efficacy and safety of cryoablation therapy for the treatment of post mastectomy pain syndrome.

Study Overview

• Status: Completed
• Conditions: Post-Mastectomy Chronic Pain Syndrome (Disorder)
• Intervention / Treatment: Procedure: Cryoablation; Procedure: Therapeutic Peripheral Nerve Block (tPNB) Injection

Detailed Description

This is a prospective, randomized, parallel-group, treatment control trial with cross-over options performed at four sites. The purpose of this study is to assess the efficacy and safety of cryoablation therapy for the treatment of post mastectomy pain syndrome.

Participants will be randomized to receive cryoablation or a therapeutic peripheral nerve block injection (tPNB). All participants will be evaluated at baseline and after treatment at 10 days, 90 days, and 180 days via clinical visits.

The option to undergo cryoablation or tPNB will be offered to all participants at the end of the 90 day post-procedure assessment. Each subject that elects the crossover intervention will be assessed over the same time period and in an identical fashion to the initial intervention, including a final long term follow up (LTFU) assessment at 180 days post-cryoablation.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown
    • Atlanta, Georgia, United States, 30342
      • Emory St. Joseph's Hospital
    • Johns Creek, Georgia, United States, 30097
      • Emory Johns Creek Hospital

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 breast surgical intervention, to include mastectomy, partial mastectomy, lumpectomy, or reconstruction
• Persistent pain in the distribution of the Intercostobrachial nerve: the residual breast, surgical bed, ipsilateral medial arm, and/or axilla following tissue healing (> 1 month postoperative)
• Positive response to local anesthetic nerve block, performed under imaging guidance. A positive response is defined as a ≥ 3 point change on a standard 11 point visual analog scale (VAS)
• Ability and willingness to provide informed consent

Exclusion Criteria:

• Active infection
• Underlying cervical segmentation or other cervical spinal anomaly that results in differential nerve root pressures
• Immunosuppression
• Uncorrectable coagulopathy
• Currently pregnant, nursing or planning to become pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cryoablation Group; After an initial diagnostic visit to locate the pain causing nerve, participants randomized to this arm will receive the cryoablation procedure. Participants will have the option to crossover to tPNB 90 days post the initial intervention.	Procedure: Cryoablation; The cryoablation procedure, a needle will be inserted and directed toward the target pain area. More than one needle may need to be used. A CT scan will be done during the procedure to help guide the needle which will be held in position by the study doctor(s) once it reaches the target area. With the needle(s) in place, the study doctor(s) will freeze the nerve over 5 minutes. A 3 minutes thaw will follow, then a second 5 minutes freeze and a final 3minute thaw. This portion of the procedure can last from 25 to 45 minutes. Once the nerve has been properly treated, the cryoablation needle(s) will be withdrawn.
ACTIVE_COMPARATOR: Control Group; After an initial diagnostic visit to locate the pain causing nerve, participants randomized to this arm will receive the nerve block procedure. Participants will have the option to crossover to cryoablation treatment 90 days post the initial intervention.	Procedure: Therapeutic Peripheral Nerve Block (tPNB) Injection; During the nerve block procedure, a needle will be inserted and directed toward the target pain area. More than one needle may need to be used. A CT scan will be done during the procedure to help guide the needle which will be held in position by the study doctor(s) once it reaches the target area and anesthetic will be injected into the targeted area. The tPNB injection consists of 4 cc of 0.25% Bupivicaine and 1 cc of 6mg/ml betamethasone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Breast Pain Intensity assessed by the Visual Analog Scale (VAS) Score	Participants' ratings of perceived pain intensity will be captured with the VAS, a 10cm horizontal line with the extremes labeled, "No pain" and "Worst Possible Pain. Participants mark a point along the continuum and it is scored by measuring the distance, in mm, from the "no pain" end to the participant's mark. A greater the distance from the "no pain" mark to the participants mark indicates greater pain.	Baseline, Post-Intervention (24 Hours)
Change in Numerical Rating Scale (NRS) of Pain Intensity Score	The NRS is an 11-point rating scale with 0 = "No Pain" and 10 = "Pain as bad as you can imagine". Total scores range from 0-10 points, with higher scores indicating greater pain intensity.	Baseline, Post-Intervention (24 Hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Change Scale (PGIC) Score	The PGIC is a comprehensive, single-item estimate of treatment-related improvement that asks participants to consider their current status compared to pre-treatment and rate it on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse). Total scores range from 1 to 7; 1 representing no change and 7 representing considerable improvement.	Post-Intervention (Up to 24 Hours)
Brief Pain Inventory Short Form (BPI) Score	The BPI captures two broad pain domains: 1) the sensory intensity of pain, and 2) the degree to which pain interferes with different areas of life. Scores are based on the two domains: the pain severity score is the mean of items 3-6 (pain at its worst, pain at its least). The pain interference score is the mean of items 9A-9G (interference of pain with: general activity, mood, walking, normal work, relations, sleep,enjoyment of life). Higher pain scores indicate greater pain and greater interference with daily activities.	Post-Intervention (Up to 24 Hours)
McGill Pain Questionnaire Short Form 2 (MPQ) Score	The MPQ consists of 24 assessments: 22 questions list a qualitative description of pain symptoms that patients may have felt during the past week and 1 question evaluates present pain intensity, both of which are rated on a numerical rating scale with 0= "None" and 10= "Worst Possible"; the final question evaluates the patient's overall total pain experience on a 6-item scale (no pain, mild, discomforting, distressing, horrible, excruciating). Total scores are on a continuum. The higher the total score, the pain experience for the participant increases.	Post-Intervention (Up to 24 Hours)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lost to Follow Up Rate	The number of participants who cannot be contacted prior to completing all study visits.	Duration of Study (Up to 180 Days)
Death Rate	The number of deaths that occur throughout the duration of the study.	Duration of Study (Up to 180 Days)
Participant Withdrawal Rate	The number of participants who withdraw from the study prior to completing all visits and after providing consent for participation.	Duration of Study (Up to 180 Days)
Declination Rate	The number of eligible participants who decline study participation after being approached to participate.	Duration of Study (Up to 180 Days)
Screen Failure Rate	The number of participants who are not eligible for study participation after conducting screening procedures.	Duration of Study (Up to 180 Days)
Percent Post Mastectomy Participants Enrolled	Of the total number of post mastectomy patients at all sites, the percentage of patients who have consented to study participation.	Post Study Completion (Up to 2 Years)
Participant Retention Rate	The number of participants who sign consent and complete all study visits.	Duration of Study (Up to 180 Days)
Total Recruitment Number	The total number of participants recruited to the study.	Duration of Study (Up to 180 Days)
Frequency of Breakthrough Pain Events	The frequency of breakthrough pain events that require emergency or rescue analgesic use measured in hours.	Duration of Study (Up to 180 Days)
Number of Breakthrough Pain Events	The number of breakthrough pain events that require emergency or rescue analgesic use reported during study visits.	Duration of Study (Up to 180 Days)
Proportion of Participants that Experience Adverse Events	The number of participants who experience adverse events divided by the total number of participants.	Duration of Study (Up to 180 Days)

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: John Prologo, MD, Emory University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2018
• Primary Completion (ACTUAL): May 19, 2021
• Study Completion (ACTUAL): May 19, 2021

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (ACTUAL): September 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Mastectomy; Nerve Pain; Breast Reconstruction; Breast Pain; Lumpectomy
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Pain; Neurologic Manifestations; Disease; Syndrome; Chronic Pain; Somatoform Disorders
• Other Study ID Numbers: IRB00094527

Drug and device information, study documents

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