An interventional study of Cryoneurolysis and No cryoneurolysis in Degenerative Joint Disease of Shoulder, sponsored by North Texas Medical Research Institute, PLLC. Recruiting at 1 site in United States. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-08-15.
Sponsored by North Texas Medical Research Institute, PLLC · Not applicable, Interventional, and Treatment
The main purpose of this research is to find out if a treatment called cryoneurolysis can reduce pain after reverse total shoulder replacement surgery. This treatment uses cold to temporarily block a nerve in the shoulder. The study will compare people who receive the treatment to those who do not, to see if it helps lower pain and reduce the need for opioid pain medications after a reverse total shoulder surgery (RTSA).
Randomized controlled, pilot clinical trial to assess the administration of and feasibility for cyroneurolysis of the suprascapular nerve in the pre-operative setting for patients that will receive a reverse total shoulder arthroplasty (RTSA). Our primary research hypothesis is that patients who receive the intervention treatment of cryoneurolysis will experience decreased opioid usage compared to the control patient population. Primary: Assess the effectiveness and feasibility of cryoneurolysis of the suprascapular nerve performed pre-operatively for RTSA patients in reduction of the cumulative opioid consumption in the post-operative of 90 days as measured by morphine milligram equivalents (MMEs) compared to those patients who did not receive the intervention prior to a RTSA.
Secondary: Assess the effectiveness of cryoneurolysis of the suprascapular nerve performed pre-operatively for RTSA patients to show:
386 studies on the registry are indexed under Joint Diseases; 64 are open to participants now.
This study's planned enrollment of 20 is below the median of 102 across 251 interventional studies indexed under Joint Diseases.
Browse Joint Diseases studies →North Texas Medical Research Institute, PLLC is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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 blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Those that do not receive cryoneurolysis of the suprascapular nerve prior to RTSA
Other: No cryoneurolysis
Those that do receive cryoneurolysis of the suprascapular nerve prior to RTSA
Device: Cryoneurolysis
Cryoneurolysis of the suprascapular nerve
Control Group
The primary endpoint for the primary objective would be decreased opioid utilization in the post-operative period after a reverse total shoulder arthroplasty (RTSA) as measured by Morphine Milligram Equivalents (MME).
Pain medication usage as recorded by MME. MME is calculated by multiplying the opioid dose (in mg) by a drug-specific conversion factor (e.g., oxycodone × 1.5, hydromorphone × 4, fentanyl patch mcg/hr × 2.4). In research and clinical practice, MME helps quantify total opioid burden, assess risk for overdose, and standardize analgesic reporting in clinical trials. Higher daily MMEs are associated with increased adverse event risk. This will be recorded at every clinical visit.
Time frame: 90 days
Decreased Pain Assessment and Documentation Tool (PADT) scores
The Pain Assessment and Documentation Tool (PADT) is a clinician-administered instrument for consistent evaluation of chronic pain in patients on analgesic therapy. It assesses: Pain Intensity (0-10 Numeric Rating Scale: 0 = no pain, 10 = worst pain imaginable; patient rates worst, least, average, and current pain over a set period), Impact on Function (interference with activity, mood, work, relationships, sleep, enjoyment of life, rated 0-10), Adverse Effects/Risk (presence and severity of medication side effects, aberrant behaviors), and Therapeutic Response (clinician summary of effectiveness and regimen changes). In clinical trials, the PADT is used at baseline and follow-up to capture pain severity, functional outcomes, and tolerability, ensuring standardized, reproducible data for efficacy and safety evaluation and is completed by the clinician and participant.
Time frame: 90 days
Improved range of motion (ROM) of the shoulder as measured by the investigators and physical therapy documentation
Improved ROM as measured by the investigators and physical therapy documentation. This will be tracked for every therapy and clinical visit. The goal is improved ROM as the patient progresses in the acute phase of post-surgical care.
Time frame: 90 days
Decreased American Shoulder and Elbow Surgeons (ASES) patient reported outcomes
The American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form is a validated tool combining patient-reported and clinician-assessed measures to evaluate shoulder function. The patient-reported section (50 points) assesses pain using a 0-10 Visual Analog Scale (converted to 50 points) and function via 10 daily activity questions (scored 0 = unable to do, 3 = no difficulty; summed and scaled to 50 points). The clinician-assessed section includes range of motion and physical exam findings but is not used in the primary score calculation. The total ASES score (0-100) is the sum of pain and function subscores, with higher scores indicating better shoulder function. In clinical trials, the ASES is administered at baseline and follow-up to quantify changes in pain and functional capacity.
Time frame: 90 days
Plan to share: No — Proprietary
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