Utility of Intermittent Cryo-Compression Versus Traditional Icing Following Arthroscopic Rotator Cuff Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAllina Health System
About this trial
Effective post - operative pain control following orthopedic surgical procedures without excessive reliance upon opioid pain medication has garnered increased attention in recent years. This study will evaluate the utilization of a non-invasive, novel cryo - compression, post-operative modality to improve pain control versus standard ice wraps in the immediate post-operative phase of arthroscopic rotator cuff surgery via a randomized controlled study design. Furthermore, if this study demonstrates improved pain control, improved quality of life and decreased opioid usage with the intermittent cold compression unit, recommendations may be considered for system-wide utilization.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients who are candidates for arthroscopic rotator cuff repair
Acute, traumatic tear of the rotator cuff in an active patient
Chronic, symptomatic tear of the rotator cuff in an active patient having failed non - operative treatment
Patient agreeable to participation in the study and able to complete informed consent process and all study requirements.
Disqualifiers
Pregnancy (per pre-operative physical)
Presence of significant glenohumeral joint osteoarthritis
Age over 70
History of clinically diagnosed lymphedema
Trial design
Design model
Parallel
Treatments tested in this trial
Cryo-compression
DeviceProgrammable intermittent compression with integrated cryo-therapy.
Cryo-therapy
Other interventionSubjects are fitted with gel ice packs and wraps.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Cryo-compressionExperimental treatment 1 intervention
Group B: Cryo-therapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of pain levels in the post-operative period using VAS Pain Scale.
Evaluate effectiveness of intermittent cryo-compression therapy versus standard ice wraps for post - operative pain control through patient reported visual analog pain scores and patient - reported opioid usage in patients undergoing arthroscopic rotator cuff repair. Pain levels will be documented by the VAS Pain Scale
Time frame
up to 15 days2
Evaluation of post-operative edema comparing pre-operative and post-operative upper arm measurements.
Evaluate effectiveness of intermittent cryo-compression therapy versus standard ice wraps for reduction of post - operative tissue swelling in patients undergoing arthroscopic rotator cuff repair by measuring circumference (inches) of upper arm using a flexible measuring tape.
Time frame
up to 15 daysSecondary outcomes
1
Cost analysis of post-operative cryotherapy modalities and other historical controls of pain post-operative pain control.
Determine cost differential of intermittent compression cryotherapy versus interscalene catheter via historical controls as well as versus standard ice wraps.
Time frame
10 days2
Quality of life evaluation comparison of post-operative cryotherapy modalities using PROMIS Global-10 scale.
Evaluate effect of intermittent cryo-compression therapy versus standard ice wraps on patient - reported quality of life via Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov