NCT07516327

Brief Summary

The purpose of this study is to compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups pre-surgically, daily after surgery for 14 days, then weekly after surgery for 3 months, and at 6 months post-surgery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
38mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Mar 2026Aug 2029

Study Start

First participant enrolled

March 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

April 1, 2026

Last Update Submit

April 9, 2026

Conditions

High-grade Partial or Full Thickness Rotator Cuff Tears

Keywords

Rotator CuffRCRCold CompressionAcute PainPost surgical pain

Outcome Measures

Primary Outcomes (1)

  • PROMIS Pain NRS subscale

    Compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups

    Enrollment to 6 months post RCR

Study Arms (2)

Standard of Care Arm

ACTIVE COMPARATOR

Patients in this arm will receive standard therapy post-surgery and discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold therapy (bag of ice or gel pack)

Other: SOC (Standard of care)

Cold and Compression

EXPERIMENTAL

Patients in this arm will be discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold \& compression therapy device provided by Sponsor)

Device: Cold and Compression

Interventions

SOC (Standard of care)OTHER

Patients enrolled in this arm will be discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold therapy (bag of ice or gel pack) Other Name:

Standard of Care Arm
Cold and CompressionDEVICE

External mechanical compression therapy (e.g., compression stockings) has been shown to reduce swelling and risk of deep vein thrombosis in the lower limbs following TKA.12,13 Combining advanced cryotherapy (continuous circulating cold flow) and dynamic compression may offer added benefits than either traditional cryotherapy (e.g., cold packs) or compression (e.g., stockings) alone.

Cold and Compression

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 35 yr or older
  • Patient of Drs. Michael Hartman (PI), Ian Elliott, Jay French, or Paul Phillips at Ochsner Kenner scheduled for arthroscopic rotator cuff repair
  • Will receive outpatient physical therapy at OTW Driftwood for the entire post-op rehabilitation period
  • English speaking
  • Diagnosis of high-grade partial or full thickness rotator cuff tears

You may not qualify if:

  • Chronic opioid use
  • Opioid use within the last 3 months
  • Diagnosis of inflammatory disease process (i.e., gout, rheumatoid arthritis, systematic lupus erythematosus...)
  • Discharge to skilled nursing
  • Cold intolerance related to diseases, like Raynaud's
  • Significant vascular impairment in the affected region
  • Current clinical signs of inflammatory phlebitis, venous ulcers, or cellulitis
  • Significant risk factors or current clinical signs of embolism (e.g., pulmonary embolus, pulmonary edema, cerebral infarction, atrial fibrillation, endocarditis, myocardial infarction, or atheromatous embolic plaque)
  • A condition in which increased venous or lymphatic return is not desired in the affected extremity (e.g., lymphedema after breast cancer or other local carcinoma and/or carcinoma metastasis in the affected extremity).
  • Uncontrolled hypertension (physician discretion), cardiac failure, extreme low blood pressure, or decompensated cardiac insufficiency.
  • Localized unstable skin condition (e.g., dermatitis, vein ligation, gangrene, or recent skin graft) in the affected region.
  • Had recent toe surgery in the affected region
  • Current clinical signs in the affected region of significant peripheral edema (e.g., deep vein thrombosis, chronic venous insufficiency, acute compartment syndrome, systemic venous hypertension, congestive heart failure, cirrhosis/liver failure, renal failure).
  • An acute, unstable (untreated) fracture in the affected region.
  • Any active local or systemic infection.
  • +30 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ochsner Medical Center - Kenner

Kenner, Louisiana, 70065, United States

RECRUITING

Related Publications (11)

  • Su EP, Perna M, Boettner F, et al. A prospective, multi-center, randomised trial to evaluate the efficacy of a cryopneumatic device on total knee arthroplasty recovery. J Bone Joint Surg Br. 2012; 94(11 Suppl A):153-6.

    BACKGROUND

  • Song M, Sun X, Tian X, et al. Compressive cryotherapy versus cryotherapy alone in patients undergoing knee surgery: a meta-analysis. Springerplus. 2016; 5(1):1074.

    BACKGROUND

  • Murgier J, Cailliez J, Wargny M, Chiron P, Cavaignac E, Laffosse JM. Cryotherapy with dynamic intermittent compression improves recovery from revision total knee arthroplasty. J Arthroplasty. 2017; 32(9):2788-91.

    BACKGROUND

  • Quesnot A, Mouchel S, Salah SB, Baranes I, Martinez L, Billuart F. Randomized controlled trial of compressive cryotherapy versus standard cryotherapy after total knee arthroplasty: pain, swelling, range of motion and functional recovery. BMC Musculoskelet Disord. 2024; 25(1):182.

    BACKGROUND

  • Chughtai M, Sodhi N, Jawad M, et al. Cryotherapy treatment after unicompartmental and total knee arthroplasty: A review. J Arthroplasty. 2017; 32(12):3822-32.

    BACKGROUND

  • Kraeutler MJ, Reynolds KA, Long C, McCarty EC. Compressive cryotherapy versus ice-a prospective, randomized study on postoperative pain in patients undergoing arthroscopic rotator cuff repair or subacromial decompression. J Shoulder Elbow Surg. 2015 Jun;24(6):854-9. doi: 10.1016/j.jse.2015.02.004. Epub 2015 Mar 29.

    PMID: 25825138BACKGROUND

  • Kunkle BF, Kothandaraman V, Goodloe JB, Curry EJ, Friedman RJ, Li X, Eichinger JK. Orthopaedic Application of Cryotherapy: A Comprehensive Review of the History, Basic Science, Methods, and Clinical Effectiveness. JBJS Rev. 2021 Jan 26;9(1):e20.00016. doi: 10.2106/JBJS.RVW.20.00016.

    PMID: 33512971BACKGROUND

  • Kara YS, Hapa O, Isin Y, Kilic AI, Havitcioglu H. A comparison of ice wrap and subacromial injection for postoperative pain and edema control following arthroscopic rotator cuff repair. J Orthop Traumatol. 2020 Sep 2;21(1):17. doi: 10.1186/s10195-020-00556-6.

    PMID: 32876791BACKGROUND

  • Uquillas CA, Capogna BM, Rossy WH, Mahure SA, Rokito AS. Postoperative pain control after arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2016 Jul;25(7):1204-13. doi: 10.1016/j.jse.2016.01.026. Epub 2016 Apr 11.

    PMID: 27079219BACKGROUND

  • Tang H, Yang P, Wang X, Zhao B, Ling K. Assessment of the efficacy of early versus delayed mobility exercise after arthroscopic rotator cuff repair. Int Orthop. 2025 Jun;49(6):1411-1420. doi: 10.1007/s00264-025-06477-5. Epub 2025 Mar 7.

    PMID: 40053065BACKGROUND

  • Nicholson AD, Estrada JA, Mathew JI, Finocchiaro A, Pinnamaneni S, Okeke L, Dines DM, Dines JS, Taylor SA, Warren RF, Cordasco FA, Rodeo SA, Gulotta LV. Minimum 15-year follow-up for clinical outcomes of arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2022 Aug;31(8):1696-1703. doi: 10.1016/j.jse.2022.01.116. Epub 2022 Feb 11.

    PMID: 35158066BACKGROUND

MeSH Terms

Conditions

Acute PainPain, Postoperative

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Michael Hartman, MD

    Ochsner Medical Center - Kenner

    PRINCIPAL INVESTIGATOR

  • Paul Phillips, MD

    Ochsner Medical Center - Kenner

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Hartman, MD

CONTACT

(504) 412-1705mhart1@lsuhsc.edu

Ken Bode

CONTACT

504-842-1936ken.bode@ochsner.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 8, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

August 31, 2029

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations

US(1)