Shoulder Disease, Shoulder Injuries
Conditions
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.
Interventions
DEVICEGame Ready ATX shoulder wrap; Game Ready GRPro 2.1
the Game Ready ATX shoulder wrap that is anatomically engineered for the shoulder joint. The wrap is connected to the Game Ready GRPro 2.1 system enabling the integrated delivery of continuous cold and intermittent pneumatic compression therapy to the shoulder joint and surrounding soft tissues.
OTHERStandard Care
Participants will undergo post-surgical cryotherapy using the treating surgeons preferred method of cryotherapy, which can include rest, ice, and compression using standard ice packs or bag of ice, a cryocuff, or other such device.
Sponsors
CoolSystems, Inc.
Encore Research Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. men or women aged 18 years and older; 2. undergoing a unilateral primary or revision shoulder surgery (total shoulder replacement or arthroscopic surgery \[rotator cuff repair, subacromial decompression, Bankart repair, Latarjet repair, debridement\]).
Exclusion criteria
1. patients undergoing bilateral surgery; 2. patients who are pregnant or nursing; 3. patients that do not believe they can comply with the study protocol; 4. patients generally unfit for surgery; 5. patients with specific treatment preferences; 6. patients who are unable to complete questionnaires due to language barriers, decreased mental capacity, neuro-psychological problems; 7. social factors precluding follow-up; 8) inability or unwillingness to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Canada
Outcome results
None listed