N/A
N=49
Compression and Cold Therapy on the Post-Operative Shoulder
Postoperative Pain · Shoulder Pain
Bottom Line
View on ClinicalTrials.gov: NCT00703729 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: Patient Reported Pain on Day 0 — 30.2; 24.2 Visual Analog Score (0-100)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cold Compression (CC) (Device); Ice Wrap (IW) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Reported Pain on Day 0 |
30.2; 24.2 | — |
| PRIMARY Patient Reported Pain on Day 1 |
38.8; 47.4 | — |
| PRIMARY Patient Reported Pain on Day 2 |
34.5; 36.5 | — |
| PRIMARY Patient Reported Pain on Day 3 |
30.1; 33.2 | — |
| PRIMARY Patient Reported Pain on Day 4 |
30.6; 33.5 | — |
| PRIMARY Patient Reported Pain on Day 5 |
23.4; 28.0 | — |
| PRIMARY Patient Reported Pain on Day 6 |
27.3; 26.0 | — |
| PRIMARY Patient Reported Pain on Day 7 |
24.8; 23.0 | — |
| SECONDARY Use of Pain Medication on Day 1 |
38.6; 37.3 | — |
| SECONDARY Use of Pain Medication on Day 2 |
38.0; 33.2 | — |
| SECONDARY Use of Pain Medication on Day 3 |
30.5; 28.9 | — |
| SECONDARY Use of Pain Medication on Day 4 |
22.8; 14.3 | — |
| SECONDARY Use of Pain Medication on Day 5 |
18.9; 11.0 | — |
| SECONDARY Use of Pain Medication on Day 6 |
18.1; 7.7 | — |
| SECONDARY Use of Pain Medication on Day 7 |
11.8; 6.3 | — |
Summary
The purpose of this study is to evaluate and compare clinical post-operative outcomes for patients using active cooling and compression device and those using ice bags and elastic wrap after acromioplasty or arthroscopic rotator cuff repair.
Eligibility Criteria
Inclusion Criteria
- Patient has undergone unilateral Rotator cuff repair or Acromioplasty
- Willing to sign a consent form
- Able to follow study procedures
Exclusion Criteria
- Non-ambulatory
- Participation in concurrent investigational protocol
- Any bleeding coagulopathies
- Raynaud's disease or other vasospastic hypersensitivity or circulatory syndromes
- Hypertension (due to secondary vasoconstriction)
- Compromised local circulation (including localized compromise due to multiple surgical procedures)
- A history of vascular impairment (such as frostbite or arterial sclerosis)
- Cold allergy (cold urticaria) or prior adverse reactions to cold application
- Rheumatoid arthritis
- Local limb ischemia
- Paroxysmal cold hemoglobinuria
- Cryoglobulinemia or any disease that produces a marked cold pressor response
- Inflammatory phlebitis
- Acute inflammations of the veins (thrombophlebitis)
- Decompensated cardiac insufficiency
- Arterial dysregulation
- Erysipelas
- Deep acute venal thrombosis (phlebothrombosis)
- Carcinoma and carcinoma metastasis in the affected extremity
- Decompensated hypertonia
- Pulmonary embolisms
- Congestive heart failure
- Pulmonary edema
- Suspected deep vein thrombosis
- Acute inflammatory skin diseases
- Infection
- Venous or arterial occlusive disease
Data sourced from ClinicalTrials.gov (NCT00703729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.