Cryoablation for Post Mastectomy Pain Syndrome

NCT03293940 | Completed DMC

• 1 other identifier: IRB00094527
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Post-Mastectomy Chronic Pain Syndrome (Disorder)

Keywords

Breast Pain; Nerve Pain; Mastectomy; Lumpectomy; Breast Reconstruction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Patient Global Impression of Change Scale (PGIC) Score

  Post-Intervention (Up to 24 Hours)

• Brief Pain Inventory Short Form (BPI) Score

  Post-Intervention (Up to 24 Hours)

• McGill Pain Questionnaire Short Form 2 (MPQ) Score

  Post-Intervention (Up to 24 Hours)

Other Outcomes (11)

• Lost to Follow Up Rate

  Duration of Study (Up to 180 Days)

• Death Rate

  Duration of Study (Up to 180 Days)

• Participant Withdrawal Rate

  Duration of Study (Up to 180 Days)

Study Arms (2)

Cryoablation Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Cryoablation PROCEDURE

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.

Cryoablation Group

Therapeutic Peripheral Nerve Block (tPNB) Injection PROCEDURE

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.

Control Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (4)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Emory St. Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097, United States

Location

MeSH Terms

Conditions

Mastodynia; Neuralgia

Interventions

Cryosurgery; Injections

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• John Prologo, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 26, 2017
• Study Start: January 10, 2018
• Primary Completion: May 19, 2021
• Study Completion: May 19, 2021
• Last Updated: October 8, 2021

Record last verified: 2021-10

Locations

US (4)