Back to resultsCryoablation for Post Mastectomy Pain Syndrome
Primary Purpose
Post-Mastectomy Chronic Pain Syndrome (Disorder)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cryoablation
Therapeutic Peripheral Nerve Block (tPNB) Injection
Sponsored by
About this trial
This is an interventional treatment trial for Post-Mastectomy Chronic Pain Syndrome (Disorder) focused on measuring Breast Pain, Nerve Pain, Mastectomy, Lumpectomy, Breast Reconstruction
Eligibility Criteria
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.
Sites / Locations
- Emory University Hospital Midtown
- Emory University Hospital
- Emory St. Joseph's Hospital
- Emory Johns Creek Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cryoablation Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03293940
Brief Title
Cryoablation for Post Mastectomy Pain Syndrome
Official Title
Percutaneous Image Guided Cryoablation of the Intercostobrachial Nerve for Management of Post Mastectomy Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
May 19, 2021 (Actual)
Study Completion Date
May 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Mastectomy Chronic Pain Syndrome (Disorder)
Keywords
Breast Pain, Nerve Pain, Mastectomy, Lumpectomy, Breast Reconstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cryoablation Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cryoablation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Peripheral Nerve Block (tPNB) Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Breast Pain Intensity assessed by the Visual Analog Scale (VAS) Score
Description
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.
Time Frame
Baseline, Post-Intervention (24 Hours)
Title
Change in Numerical Rating Scale (NRS) of Pain Intensity Score
Description
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.
Time Frame
Baseline, Post-Intervention (24 Hours)
Secondary Outcome Measure Information:
Title
Patient Global Impression of Change Scale (PGIC) Score
Description
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.
Time Frame
Post-Intervention (Up to 24 Hours)
Title
Brief Pain Inventory Short Form (BPI) Score
Description
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.
Time Frame
Post-Intervention (Up to 24 Hours)
Title
McGill Pain Questionnaire Short Form 2 (MPQ) Score
Description
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.
Time Frame
Post-Intervention (Up to 24 Hours)
Other Pre-specified Outcome Measures:
Title
Lost to Follow Up Rate
Description
The number of participants who cannot be contacted prior to completing all study visits.
Time Frame
Duration of Study (Up to 180 Days)
Title
Death Rate
Description
The number of deaths that occur throughout the duration of the study.
Time Frame
Duration of Study (Up to 180 Days)
Title
Participant Withdrawal Rate
Description
The number of participants who withdraw from the study prior to completing all visits and after providing consent for participation.
Time Frame
Duration of Study (Up to 180 Days)
Title
Declination Rate
Description
The number of eligible participants who decline study participation after being approached to participate.
Time Frame
Duration of Study (Up to 180 Days)
Title
Screen Failure Rate
Description
The number of participants who are not eligible for study participation after conducting screening procedures.
Time Frame
Duration of Study (Up to 180 Days)
Title
Percent Post Mastectomy Participants Enrolled
Description
Of the total number of post mastectomy patients at all sites, the percentage of patients who have consented to study participation.
Time Frame
Post Study Completion (Up to 2 Years)
Title
Participant Retention Rate
Description
The number of participants who sign consent and complete all study visits.
Time Frame
Duration of Study (Up to 180 Days)
Title
Total Recruitment Number
Description
The total number of participants recruited to the study.
Time Frame
Duration of Study (Up to 180 Days)
Title
Frequency of Breakthrough Pain Events
Description
The frequency of breakthrough pain events that require emergency or rescue analgesic use measured in hours.
Time Frame
Duration of Study (Up to 180 Days)
Title
Number of Breakthrough Pain Events
Description
The number of breakthrough pain events that require emergency or rescue analgesic use reported during study visits.
Time Frame
Duration of Study (Up to 180 Days)
Title
Proportion of Participants that Experience Adverse Events
Description
The number of participants who experience adverse events divided by the total number of participants.
Time Frame
Duration of Study (Up to 180 Days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Prologo, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory St. Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Emory Johns Creek Hospital
City
Johns Creek
State/Province
Georgia
ZIP/Postal Code
30097
Country
United States
12. IPD Sharing Statement
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Cryoablation for Post Mastectomy Pain Syndrome
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