An interventional study of Cryoablation and Therapeutic Peripheral Nerve Block (tPNB) Injection in Post-Mastectomy Chronic Pain Syndrome (Disorder), sponsored by Emory University. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-08.
Sponsored by Emory University · Not applicable, Interventional, and Treatment
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.
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.
44 studies on the registry are indexed under Mastodynia; 10 are open to participants now.
This study's enrollment of 35 is below the median of 60 across 37 interventional studies indexed under Mastodynia.
Browse Mastodynia studies →Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: 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.
Time frame: Baseline, Post-Intervention (24 Hours)
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.
Time frame: 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.
Time frame: 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.
Time frame: Post-Intervention (Up to 24 Hours)
Lost to Follow Up Rate
The number of participants who cannot be contacted prior to completing all study visits.
Time frame: Duration of Study (Up to 180 Days)
Death Rate
The number of deaths that occur throughout the duration of the study.
Time frame: 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.
Time frame: Duration of Study (Up to 180 Days)
Declination Rate
The number of eligible participants who decline study participation after being approached to participate.
Time frame: 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.
Time frame: 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.
Time frame: Post Study Completion (Up to 2 Years)
Participant Retention Rate
The number of participants who sign consent and complete all study visits.
Time frame: Duration of Study (Up to 180 Days)
Total Recruitment Number
The total number of participants recruited to the study.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Duration of Study (Up to 180 Days)
Ran from Jan 2018 to primary completion in May 2021, 40 months.
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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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