Randomized-Controlled Trial and Evaluation Cohort Study of Patients Using a Cryopneumatic Device After Open or Arthroscopic Shoulder Surgeries
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Shoulder Injuries
- Sponsor
- Encore Research Inc.
- Enrollment
- 200
- Locations
- 5
- Primary Endpoint
- Numeric Pain Rating Scale (NPRS)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •men or women aged 18 years and older;
- •undergoing a unilateral primary or revision shoulder surgery (total shoulder replacement or arthroscopic surgery \[rotator cuff repair, subacromial decompression, Bankart repair, Latarjet repair, debridement\]).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Numeric Pain Rating Scale (NPRS)
Time Frame: 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 Outcomes
- Narcotic Consumption(12 weeks)
- Number of patients with adverse events; number of adverse events(12 weeks)
- European Quality of Life measure (EQ-5D)(12 weeks)
- Net Promoter Score(12 weeks)