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NCT04185064
Cryopneumatic Device After Shoulder Surgeries
NA trial testing Game Ready ATX shoulder wrap; Game Ready GRPro 2.1 in Shoulder Injuries in 200 participants. Completed in 17 May 2023.
17 May 2023
Quick facts
| Lead sponsor | Encore Research Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 1 September 2020 |
| Primary completion | 17 May 2023 |
| Estimated completion | 17 May 2023 |
| Sites | 5 locations across Canada |
Drugs / interventions tested
- Game Ready ATX shoulder wrap; Game Ready GRPro 2.1
- Standard Care — full drug profile →
Conditions studied
- Shoulder Injuries — all drugs for Shoulder Injuries →
- Shoulder Disease — all drugs for Shoulder Disease →
Sponsor
Encore Research Inc.
Who can join
18 and older, any sex, with Shoulder Injuries or Shoulder Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Cryo-Pneumatic Compression Results in a Significant Decrease in Opioid Consumption After Shoulder Surgery: A Multicenter Randomized Controlled Trial.
Khan M, Phillips SA, Mathew P, Venkateswaran V, et al · · 2024 · cited 3× · PMID 39165152 · DOI 10.1177/03635465241270138
Verify or expand the search:
- PubMed search for NCT04185064
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Shoulder Injuries
Currently open trials in the same condition.
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- NCT06866054 — Serratus Posterior Superior Intercostal Plane Block for Arthroscopic Shoulder Surgery · NA · recruiting
- NCT07055685 — Effects of Upper Limb PRT With CSE on Pain, Core Strength and ULB in Cricket Fast Bowlers With Shoulder Injury · NA · active not recruiting
- NCT06485934 — Kinesiophobia Scale for the Upper Extremity · recruiting
- NCT06016257 — Using VirtuaCareTM Platform for Home Programs in Acute and Chronic Shoulder Conditions: A Pilot Study · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04185064 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Encore Research Inc.
- Last refreshed: 2 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04185064.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing