Cryopneumatic Device After Shoulder Surgeries
- Conditions
- Shoulder InjuriesShoulder Disease
- Interventions
- Device: Game Ready ATX shoulder wrap; Game Ready GRPro 2.1Other: Standard Care
- Registration Number
- NCT04185064
- Lead Sponsor
- Encore Research Inc.
- Brief Summary
This study randomize patients to receive either a cryopneumatic device or standard care (ice and ice packs) following open or arthroscopic shoulder surgeries. The primary objective is to determine the impact of the cryopneumatic device on post-surgery pain management, while secondary objectives are to detemine the effect on pain, patient eperience, quality of life, narcotic consumption and time to stop narcotic usage. Patients who do not wish to participate in the randomized portion of the trial will be invited to participate in an observational cohort who will all receive the cryopneumatic device. Patients who wish to enter this cohort will not have the device provided to them for free, and will either use their insurance or pay for the device, in order to determine if patients who pay demonstrate different outcomes from the patients receiving the device for free in the RCT.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- men or women aged 18 years and older;
- undergoing a unilateral primary or revision shoulder surgery (total shoulder replacement or arthroscopic surgery [rotator cuff repair, subacromial decompression, Bankart repair, Latarjet repair, debridement]).
- patients undergoing bilateral surgery;
- patients who are pregnant or nursing;
- patients that do not believe they can comply with the study protocol;
- patients generally unfit for surgery;
- patients with specific treatment preferences;
- patients who are unable to complete questionnaires due to language barriers, decreased mental capacity, neuro-psychological problems;
- social factors precluding follow-up; 8) inability or unwillingness to provide informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cryopnematic Device (Randomized Component) Game Ready ATX shoulder wrap; Game Ready GRPro 2.1 Game Ready shoulder wrap is applied in operating room and used in recovery room for 45 mins to 1 hour. Postop Day 1 and 2: the unit will be applied by the patient or a health care provider; as cold as comfortable (34°F; adjustable to 50°F); low compression setting; 30 min on:60 min off (use the pre-set auto program); use throughout the day; use at night as needed. Postop day 3-14 and onwards: 30 min on:60 min off (use the pre-set auto program); medium compression; as cold as comfortable (34°F; adjustable to 50°F); use minimum of twice/day. This will be combined with pain management medications, range of motion, and positioning exercises. Cryopneumatic Device (Observational Cohort) Game Ready ATX shoulder wrap; Game Ready GRPro 2.1 Game Ready® shoulder wrap is applied in the operating room and used in the recovery room for 45 mins to 1 hour. Postop Day 1 and 2: the unit will be applied by the patient or a health care provider; as cold as comfortable (34°F; adjustable to 50°F); low compression setting; 30 min on:60 min off (use the pre-set auto program); use throughout the day; use at night as needed. Postop day 3-14 and onwards: 30 min on:60 min off (use the pre-set auto program); medium compression; as cold as comfortable (34°F; adjustable to 50°F); use minimum of twice/day. This will be combined with pain management medications, range of motion, and positioning exercises Standard Care Standard Care Ice is applied in operating room and used in recovery room for 45 mins to 1 hour. Postop Day 1 and 2: the ice will be applied by the patient or a health care provider; as cold as comfortable; 30 min on:60 min off; use throughout the day; use at night as needed. Postop day 3-14 and onwards: 30 min on:60 min off; use minimum of twice/day. The patients in the control group will receive pain management strategies as would be normally dictated by the physician/therapist. This may include the use of ice, ice packs and compression bandages, as well as pain medications, range of motion, and positioning exercises
- Primary Outcome Measures
Name Time Method Numeric Pain Rating Scale (NPRS) 12 weeks The NPRS measures pain severity on an 11-item scale (0 to 10). The patients will be asked to choose a number from 0 to 10 that best describes their current pain. 0 would mean "no pain" and 10 would mean "worst possible pain".
- Secondary Outcome Measures
Name Time Method Narcotic Consumption 12 weeks Narcotic usage will be measured based on the number of narcotics consumed during the study period and the time to cease narcotic use. Details of administration will be collected and recorded on the Medication Log CRF.
Number of patients with adverse events; number of adverse events 12 weeks All adverse events will be monitored and recorded on the Adverse Event CRF.
European Quality of Life measure (EQ-5D) 12 weeks The European Quality of Life measure EQ-5D comprises 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) which are used to calculate a health status score from 0 (worst health) to 1 (best health). The EQ-5D also has a 0 (worst health) to 1 (best health) visual analog scale component.
Net Promoter Score 12 weeks Patient experience will be measured using the Net Promoter Score. Patients will rate their experience on a simple 0 (worst) to 10 (best) scale. Responses are classified into 3 groups (promotors, passives, and distractors). The Net Promoter Score is the percentage of promoters minus the percentage of detractors.
Trial Locations
- Locations (5)
Cambridge Memorial Hospital
🇨🇦Cambridge, Ontario, Canada
Georgetown Hospital
🇨🇦Georgetown, Ontario, Canada
Brantford General Hospital
🇨🇦Brantford, Ontario, Canada
St. Joseph's Hospital
🇨🇦Hamilton, Ontario, Canada
Oakville Trafalgar Hospital
🇨🇦Oakville, Ontario, Canada