High-grade Partial or Full Thickness Rotator Cuff TearsNCT07516327

Cold and Compression After Rotator Cuff Repair (RCR)

A study testing Cold and Compression in people with High-grade Partial or Full Thickness Rotator Cuff Tears, run by Ochsner Health System at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 35 years and older
Conditions the study is for: High-grade Partial or Full Thickness Rotator Cuff Tears
What is being tested?: Cold and Compression
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2026to 31 Aug 2029
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 45Show fewer

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.
Obtunded or with diabetes mellitus, multiple sclerosis, poor circulation, spinal cord injuries, and rheumatoid arthritis
Areas of skin breakdown or damage (damaged or at-risk skin) producing uneven heat conduction across the skin (e.g., open wound, scar tissue, burn or skin graft). Any open wound must be dressed prior to use of the Polar Care Wave System.
Presumptive evidence of congestive heart failure
Pre-existing DVT condition
Deep acute venal thrombosis (Phlebothrombosis)
Episodes of pulmonary embolism
Pulmonary edema
Acute inflammation of the veins (Thrombophlebitis)
Decompensated cardiac insufficiency
Arterial dysregulation
Erysipelas
Carcinoma and carcinoma metastasis in the affected extremity
Decompensated hypertonia
Acute inflammatory skin diseases or infection
Venous or arterial occlusive disease
Medical situations where increased venous or lymphatic return is undesirable
Poor peripheral circulation
Severe arteriosclerosis, or active infection
Known hematological dyscrasias that predispose to thrombosis (e.g., paroxysmal cold hemoglobinuria, cryoglobulinemia, sicklecell disease, serum cold agglutinins).
Tissues inflamed as a result of recent injury or exacerbation of chronic inflammatory condition.
Compromised local circulation or neurologic impairment (including paralysis or localized compromise due to multiple surgical procedures or diabetes) in the affected region.
Cognition or communication impairments that prevent them from giving accurate and timely feedback.
Cold allergy
Cold agglutinin disorders like paroxysmal cold hemoglobinuria
Buerger's disease
Chilblains
Cryoglobulinemia
Sickle cell anemia
Uncontrolled diabetes (physician discretion)
Hypersensitivity to cold

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Richard Hartman, MD contact

Ken Bode contact

United States1 site, 1 recruiting

Ochsner Medical Center - Kenner
Kenner, Louisiana, 70065
Michael Hartman, MD, (504) 412-1705, mhart1@lsuhsc.edu
Nicole Villemarette-Pittman, PhD, nicole.villemarettepittman@ochsner.org
Recruiting

Other trials in United States

About this study

Official title: Cold and Compression After Rotator Cuff Repair or Arthroscopic Rotator Cuff Repair Pain Attenuation: A Randomized, Controlled Trial

Conditions: High-grade Partial or Full Thickness Rotator Cuff Tears
Being tested: SOC (Standard of care), Cold and Compression
Keywords: Rotator Cuff, RCR, Cold Compression, Acute Pain, Post surgical pain
Medical subject headings: Acute Pain, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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:
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.

Study groups in NCT07516327
Study group	Role	What they receive
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) Receives: 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) Receives: Device: Cold and Compression

What is being measured

The primary outcome is the main question the study is designed to answer.

PROMIS Pain NRS subscale
Compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups
Measured: Enrollment to 6 months post RCR

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202631 Aug 2029

First posted8 Apr 2026
Study start1 Mar 2026
Primary completion1 Sep 2027 (estimated)
Study completion31 Aug 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for High-grade Partial or Full Thickness Rotator Cuff TearsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 90 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07516327
Sponsor's protocol ID: 2025.403
Status last verified: Apr 2026
First submitted: 1 Apr 2026
Last updated: 14 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided: Currently there are no plans to share the data as there are no data sharing agreements in place with other institutions.

Publications

Su EP, Perna M, Boettner F, Mayman DJ, Gerlinger T, Barsoum W, Randolph J, Lee G. 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 Nov;94(11 Suppl A):153-6. doi: 10.1302/0301-620X.94B11.30832.
PubMed 23118406
Song M, Sun X, Tian X, Zhang X, Shi T, Sun R, Dai W. Compressive cryotherapy versus cryotherapy alone in patients undergoing knee surgery: a meta-analysis. Springerplus. 2016 Jul 13;5(1):1074. doi: 10.1186/s40064-016-2690-7. eCollection 2016.
PubMed 27462522
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 Sep;32(9):2788-2791. doi: 10.1016/j.arth.2017.03.052. Epub 2017 Mar 31.
PubMed 28465126
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 Feb 28;25(1):182. doi: 10.1186/s12891-024-07310-7.
PubMed 38419032
Chughtai M, Sodhi N, Jawad M, Newman JM, Khlopas A, Bhave A, Mont MA. Cryotherapy Treatment After Unicompartmental and Total Knee Arthroplasty: A Review. J Arthroplasty. 2017 Dec;32(12):3822-3832. doi: 10.1016/j.arth.2017.07.016. Epub 2017 Jul 21.
PubMed 28802778
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.
PubMed 25825138
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.
PubMed 33512971
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.
PubMed 32876791
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.
PubMed 27079219
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.
PubMed 40053065
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.
PubMed 35158066

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cold and Compression After Rotator Cuff Repair or Arthroscopic Rotator Cuff Repair Pain Attenuation: A Randomized, Controlled Trial
ClinicalTrials.gov ID: NCT07516327
Acronym / sponsor ID: 2025.403
Conditions: High-grade Partial or Full Thickness Rotator Cuff Tears
Keywords: Rotator Cuff, RCR, Cold Compression, Acute Pain, Post surgical pain
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 90 participants (estimated)
Lead sponsor: Ochsner Health SystemUniversity, hospital or other
Collaborators: BREG, Inc
Study start: 1 Mar 2026 (actual)
Primary completion: 1 Sep 2027 (estimated)
Study completion: 31 Aug 2029 (estimated)
First posted: 8 Apr 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard of Care Arm	Active comparator	Other: SOC (Standard of care)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)
Cold and Compression	Experimental	Device: Cold and CompressionPatients 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)

Who may qualify

Ages: 35 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (45 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SOC (Standard of care)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:	Other	Standard of Care Arm
Cold and CompressionExternal 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.	Device	Cold and Compression

Primary outcome

PROMIS Pain NRS subscale
Time frame: Enrollment to 6 months post RCR
Compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
Background: PubMed 23118406Su EP, Perna M, Boettner F, Mayman DJ, Gerlinger T, Barsoum W, Randolph J, Lee G. 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 Nov;94(11 Suppl A):153-6. doi: 10.1302/0301-620X.94B11.30832.
Background: PubMed 27462522Song M, Sun X, Tian X, Zhang X, Shi T, Sun R, Dai W. Compressive cryotherapy versus cryotherapy alone in patients undergoing knee surgery: a meta-analysis. Springerplus. 2016 Jul 13;5(1):1074. doi: 10.1186/s40064-016-2690-7. eCollection 2016.
Background: PubMed 28465126Murgier 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 Sep;32(9):2788-2791. doi: 10.1016/j.arth.2017.03.052. Epub 2017 Mar 31.
Background: PubMed 38419032Quesnot 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 Feb 28;25(1):182. doi: 10.1186/s12891-024-07310-7.
Background: PubMed 28802778Chughtai M, Sodhi N, Jawad M, Newman JM, Khlopas A, Bhave A, Mont MA. Cryotherapy Treatment After Unicompartmental and Total Knee Arthroplasty: A Review. J Arthroplasty. 2017 Dec;32(12):3822-3832. doi: 10.1016/j.arth.2017.07.016. Epub 2017 Jul 21.
Background: PubMed 25825138Kraeutler 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.
Background: PubMed 33512971Kunkle 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.
Background: PubMed 32876791Kara 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.
Background: PubMed 27079219Uquillas 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.
Background: PubMed 40053065Tang 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.
Background: PubMed 35158066Nicholson 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.
Individual participant dataSharing planned: Undecided. Currently there are no plans to share the data as there are no data sharing agreements in place with other institutions.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Richard Hartman, MD contact

Ken Bode contact

Michael Hartman, MD principal investigator

Ochsner Medical Center - Kenner

Paul Phillips, MD principal investigator

Ochsner Medical Center - Kenner

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cold and Compression in people with High-grade Partial or Full Thickness Rotator Cuff Tears, run by Ochsner Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Richard Hartman, MD ((504) 412-1705, mhart1@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PROMIS Pain NRS subscale (time frame: Enrollment to 6 months post RCR). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07516327, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.