Orthopaedic Specialists of Dallas
Rockwall, Texas, 75032, United States
Location status: Recruiting
Location contact
Jeffery Neumann, PA-C
CONTACT
Mohammad U Burney, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07125833
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).
Interested in participating?
Request Info30 year–85 year
All sexes
Interventional
Not applicable
Rockwall, Texas, 75032, United States
Location status: Recruiting
Jeffery Neumann, PA-C
CONTACT
Mohammad U Burney, MD
PRINCIPAL_INVESTIGATOR
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cryoneurolysis of the suprascapular nerve
Control Group
Time frame: 90 days
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
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 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
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.
Contact information is provided by the study sponsor or research team.
North Texas Medical Research Institute, PLLC
Other
A Randomized Pilot Trial for Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07153471
Arthritis, Body Weight
Phoenix, Arizona, United States
View Trial DetailsNCT07553273
Arthropathy, Bilateral Arthritis of Hands
Galveston, Texas, United States
View Trial DetailsNCT06551389
Arthritis, Autoimmune Diseases
Brest, France
View Trial DetailsNCT04580225
Arthritis, Joint Diseases
Calgary, Alberta, Canada
View Trial Details