Cryoneurolysis of the Suprascapular Nerve for Perioperative Pain Control After Receiving a Reverse Total Shoulder Arthroplasty (RTSA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-30

Study Completion Date

2026-08-31

Brief Summary

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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).

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Detailed Description

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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:

1. a decreased pain score as measured by a Pain Assessment Documentation Tool (PADT) score
2. increased range of motion
3. 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

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Degenerative Joint Disease of Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Those that do not receive cryoneurolysis of the suprascapular nerve prior to RTSA

Group Type ACTIVE_COMPARATOR

No cryoneurolysis

Intervention Type OTHER

Control Group

Intervention

Those that do receive cryoneurolysis of the suprascapular nerve prior to RTSA

Group Type EXPERIMENTAL

Cryoneurolysis

Intervention Type DEVICE

Cryoneurolysis of the suprascapular nerve

Interventions

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Cryoneurolysis

Cryoneurolysis of the suprascapular nerve

Intervention Type DEVICE

No cryoneurolysis

Control Group

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
* 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

Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No