CompletedNot Applicable

Cryoablation for Post Mastectomy Pain Syndrome

United States35 participantsStarted 2018-01-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Breast Pain Intensity assessed by the Visual Analog Scale (VAS) Score

Timeframe: Baseline, Post-Intervention (24 Hours)

Change in Numerical Rating Scale (NRS) of Pain Intensity Score

Timeframe: Baseline, Post-Intervention (24 Hours)

Trial details

NCT IDNCT03293940

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-19

View on ClinicalTrials.gov More Post-Mastectomy Chronic Pain Syndrome (Disorder) trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.