Degenerative Joint Disease of ShoulderNCT07125833
Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty (RTSA)
A study testing Cryoneurolysis and No cryoneurolysis in people with Degenerative Joint Disease of Shoulder, run by North Texas Medical Research Institute, PLLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Degenerative Joint Disease of Shoulder
- What is being tested?
- Cryoneurolysis and No cryoneurolysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients or female who are not pregnant and do not plan on future pregnancy during trial participation
- between 30-85 years of age
- BMI less than or equal to 45
- Currently setup for an elective primary reverse total shoulder arthroplasty due to primary osteoarthritis
- Ability to provide informed consent to participate in the clinical trial
- Ability to understand and communicate in English
- Willingness to comply with all study procedures
Who cannot join
- poorly controlled comorbidities that would not allow surgical intervention such as poorly controlled diabetes (HbA1C > 8.0) renal insufficiency (eGFR <60) poorly controlled CV disease such as CHF that is NYHA class 3 and 4
- inability to receive the intervention including contraindications:
- Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and open and/or infected wounds at or near the treatment site
- patients with history of total joint infection ever or any infection in the last 6 months
- ASA score >3 and Outpatient Arthroplasty Risk Assessment (OARA; medical risk stratification scoring system to help determine day surgery vs inpatient)1 score > 80.
- previous cryoneurolysis of the suprascapular nerve-utilization of supplemental/holistic methods specifically for pain control (e.g. cannabidiol). This will be discontinued 30 days prior to RTSA and will not be used during the duration of study participation. This will be evaluated by the Principal Investigator and study team prior to consent.
Show all 9Show fewer
- significant anti-coagulation usage (other than aspirin) 7 days prior to treatment
- CV surgery within the last 6 months
- significant neurologic compromise (acquired or congenital/genetic) of the upper extremity to be operated on or underlying neurologic condition that would confound results in the opinion of the investigator such as a
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Orthopaedic Specialists of Dallas
Rockwall, Texas, 75032
Jeffery Neumann, PA-C, 972-503-9495, jneumann@dallasortho.net
Mohammad U Burney, MD
About this study
Official title: A Randomized Pilot Trial for Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty
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).
Read the detailed description
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:
- a decreased pain score as measured by a Pain Assessment Documentation Tool (PADT) score
- increased range of motion
- increased patient reported outcome scores via the American Shoulder and Elbow Surgeons (ASES) shoulder score when compared to those that did not receive any intervention prior to a RTSA?
- Conditions
- Degenerative Joint Disease of Shoulder
- Being tested
- Cryoneurolysis, No cryoneurolysis
- Keywords
- cryoneurolysis, degenerative joint disease, reverse shoulder arthroplasty
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoneurolysisDevice
Cryoneurolysis of the suprascapular nerve
No cryoneurolysisOther
Control Group
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Those that do not receive cryoneurolysis of the suprascapular nerve prior to RTSA Receives: Other: No cryoneurolysis |
| Intervention | Experimental | Those that do receive cryoneurolysis of the suprascapular nerve prior to RTSA Receives: Device: Cryoneurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start30 Jul 2025
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Degenerative Joint Disease of ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization The design of this trial will utilize a 1:1 randomization schema. Randomization will be performed by an online randomization tool from the National Cancer Institute (https://ctrandomization.cancer.gov/home/). This randomization list will be kept with the study trial documents in a secured location and initially blinded from the primary research team.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Texas Medical Research Institute, PLLC
- Sponsor type
- University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Responsible party
- Sponsor
- Investigators
- Mohammad U Burney, MD, Principal investigator, North Texas Medical Research Institute, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125833
- Sponsor's protocol ID
- IIT 24-376
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Proprietary
Publications
MacRae F, Boissonnault E, Hashemi M, Winston P. Bilateral Suprascapular Nerve Cryoneurolysis for Pain Associated With Glenohumeral Osteoarthritis: A Case Report. Arch Rehabil Res Clin Transl. 2023 Jan 25;5(1):100256. doi: 10.1016/j.arrct.2023.100256. eCollection 2023 Mar.
PubMed 36968166Best MJ, Aziz KT, Wilckens JH, McFarland EG, Srikumaran U. Increasing incidence of primary reverse and anatomic total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2021 May;30(5):1159-1166. doi: 10.1016/j.jse.2020.08.010. Epub 2020 Aug 26.
PubMed 32858194Trescot AM. Cryoanalgesia in interventional pain management. Pain Physician. 2003 Jul;6(3):345-60.
PubMed 16880882
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Trial for Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT07125833
- Acronym / sponsor ID
- IIT 24-376
- Conditions
- Degenerative Joint Disease of Shoulder
- Keywords
- cryoneurolysis, degenerative joint disease, reverse shoulder arthroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- North Texas Medical Research Institute, PLLCUniversity, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
- a decreased pain score as measured by a Pain Assessment Documentation Tool (PADT) score
- increased range of motion
- increased patient reported outcome scores via the American Shoulder and Elbow Surgeons (ASES) shoulder score when compared to those that did not receive any intervention prior to a RTSA?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization The design of this trial will utilize a 1:1 randomization schema. Randomization will be performed by an online randomization tool from the National Cancer Institute (https://ctrandomization.cancer.gov/home/). This randomization list will be kept with the study trial documents in a secured location and initially blinded from the primary research team.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: No cryoneurolysisThose that do not receive cryoneurolysis of the suprascapular nerve prior to RTSA |
| Intervention | Experimental | Device: CryoneurolysisThose that do receive cryoneurolysis of the suprascapular nerve prior to RTSA |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male patients or female who are not pregnant and do not plan on future pregnancy during trial participation
- between 30-85 years of age
- BMI less than or equal to 45
- Currently setup for an elective primary reverse total shoulder arthroplasty due to primary osteoarthritis
- Ability to provide informed consent to participate in the clinical trial
Key exclusion criteria (9 listed)
- poorly controlled comorbidities that would not allow surgical intervention such as poorly controlled diabetes (HbA1C > 8.0) renal insufficiency (eGFR <60) poorly controlled CV disease such as CHF that is NYHA class 3 and 4
- inability to receive the intervention including contraindications:
- Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and open and/or infected wounds at or near the treatment site
- patients with history of total joint infection ever or any infection in the last 6 months
- ASA score >3 and Outpatient Arthroplasty Risk Assessment (OARA; medical risk stratification scoring system to help determine day surgery vs inpatient)1 score > 80.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoneurolysisCryoneurolysis of the suprascapular nerve | Device | Intervention |
| No cryoneurolysisControl Group | Other | Control |
Primary outcome
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).
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.
3 secondary outcomes
Decreased Pain Assessment and Documentation Tool (PADT) scores
Time frame: 90 days
Improved range of motion (ROM) of the shoulder as measured by the investigators and physical therapy documentation
Time frame: 90 days
Decreased American Shoulder and Elbow Surgeons (ASES) patient reported outcomes
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Background: PubMed 36968166MacRae F, Boissonnault E, Hashemi M, Winston P. Bilateral Suprascapular Nerve Cryoneurolysis for Pain Associated With Glenohumeral Osteoarthritis: A Case Report. Arch Rehabil Res Clin Transl. 2023 Jan 25;5(1):100256. doi: 10.1016/j.arrct.2023.100256. eCollection 2023 Mar.
- Background: PubMed 32858194Best MJ, Aziz KT, Wilckens JH, McFarland EG, Srikumaran U. Increasing incidence of primary reverse and anatomic total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2021 May;30(5):1159-1166. doi: 10.1016/j.jse.2020.08.010. Epub 2020 Aug 26.
- Background: PubMed 16880882Trescot AM. Cryoanalgesia in interventional pain management. Pain Physician. 2003 Jul;6(3):345-60.
- Individual participant dataSharing planned: No. Proprietary
Related trials for Degenerative Joint Disease of Shoulder
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Not yet recruitingObservational study
Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
Knee Osteoarthristis, Hip Osteoarthritis
Not yet recruiting
Clinical Evaluation of TrHCROSS® for Different Joints
Joint Osteoarthritis, Knee Osteoarthristis
RecruitingPhase 4
PRP for Glenohumeral Osteoarthritis
Shoulder Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammad U Burney, MD principal investigator
North Texas Medical Research Institute, PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoneurolysis and No cryoneurolysis in people with Degenerative Joint Disease of Shoulder, run by North Texas Medical Research Institute, PLLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeff Neumann, PA-C (972-503-9495, jneumann@dallasortho.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07125833, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.