ClinicalTrials.gg
RecruitingNCT07516327Updated Apr 14, 2026

Cold and Compression After Rotator Cuff Repair (RCR)

An interventional study of SOC (Standard of care) and Cold and Compression in High-grade Partial or Full Thickness Rotator Cuff Tears, sponsored by Ochsner Health System. Recruiting at 1 site in United States. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by Ochsner Health System · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
35 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 350 studies in Acute Pain with a site in United States — 47 open to participants now, 52 under way, none of them phase 3. Acute Pain · United States.

Planned enrollment
155th of 319
90 · median 82
Started
2026
with 11 others
No phase
122 of 350
25 open now
Primary completion
2027-09
later than 36 of 51 live
Registered
341st of 350
by date

Among the 350 studies in Acute Pain with a site in United States, this one is the 155th largest by planned enrollment of the 319 interventional ones that give a count, is one of 12 that started in 2026, is one of 122 with no phase, reaches primary completion later than 36 of the 51 other live ones, and was the 341st registered.

Acute Pain

1,073 studies on the registry are indexed under Acute Pain; 166 are open to participants now.

Browse Acute Pain studies →

Open to participants now

47 of the 350 studies in Acute Pain with a site in United States are open now. Recruiting first, the newest first:

41 more — sign in →

All 47 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 101 Acute Pain studies recruiting now, 39 (39%) set no upper age limit and 49 (49%) stop at 75 or younger; 21 take children under 18; 24 take healthy volunteers.

This study: 35 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • High-grade Partial or Full Thickness Rotator Cuff Tears

Keywords

  • Rotator Cuff
  • RCR
  • Cold Compression
  • Acute Pain
  • Post surgical pain
04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Chronic opioid use
  2. Opioid use within the last 3 months
  3. Diagnosis of inflammatory disease process (i.e., gout, rheumatoid arthritis, systematic lupus erythematosus...)
  4. Discharge to skilled nursing
  5. Cold intolerance related to diseases, like Raynaud's
  6. Significant vascular impairment in the affected region
  7. Current clinical signs of inflammatory phlebitis, venous ulcers, or cellulitis
  8. 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)
  9. 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 in the affected extremity).
  10. Uncontrolled hypertension (physician discretion), cardiac failure, extreme low blood pressure, or decompensated cardiac insufficiency.
  11. Localized unstable skin condition (e.g., dermatitis, vein ligation, gangrene, or recent skin graft) in the affected region.
  12. Had recent toe surgery in the affected region
  13. 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).
  14. An acute, unstable (untreated) fracture in the affected region.
  15. Any active local or systemic infection.
  16. Obtunded or with diabetes mellitus, multiple sclerosis, poor circulation, spinal cord injuries, and rheumatoid arthritis
  17. 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.
  18. Presumptive evidence of congestive heart failure
  19. Pre-existing DVT condition
  20. Deep acute venal thrombosis (Phlebothrombosis)
  21. Episodes of pulmonary embolism
  22. Pulmonary edema
  23. Acute inflammation of the veins (Thrombophlebitis)
  24. Decompensated cardiac insufficiency
  25. Arterial dysregulation
  26. Erysipelas
  27. Carcinoma and carcinoma metastasis in the affected extremity
  28. Decompensated hypertonia
  29. Acute inflammatory skin diseases or infection
  30. Venous or arterial occlusive disease
  31. Medical situations where increased venous or lymphatic return is undesirable
  32. Poor peripheral circulation
  33. Severe arteriosclerosis, or active infection
  34. Known hematological dyscrasias that predispose to thrombosis (e.g., paroxysmal cold hemoglobinuria, cryoglobulinemia, sicklecell disease, serum cold agglutinins).
  35. Tissues inflamed as a result of recent injury or exacerbation of chronic inflammatory condition.
  36. Compromised local circulation or neurologic impairment (including paralysis or localized compromise due to multiple surgical procedures or diabetes) in the affected region.
  37. Cognition or communication impairments that prevent them from giving accurate and timely feedback.
  38. Cold allergy
  39. Cold agglutinin disorders like paroxysmal cold hemoglobinuria
  40. Buerger's disease
  41. Chilblains
  42. Cryoglobulinemia
  43. Sickle cell anemia
  44. Uncontrolled diabetes (physician discretion)
  45. to cold
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    Standard of Care Arm

    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)

  • Experimental
    Cold and Compression

    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

  • OtherSOC (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:

  • DeviceCold and Compression

    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.

06

What researchers measure

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

    Time frame: Enrollment to 6 months post RCR

07

Study locations

1 of 1 sites recruiting
  • Ochsner Medical Center - Kenner
    Kenner, Louisiana 70065, United States
    Recruiting
    • Michael Hartman, MD · Contactmhart1@lsuhsc.edu · (504) 412-1705
    • Nicole Villemarette-Pittman, PhD · Contactnicole.villemarettepittman@ochsner.org
    • Michael Hartman, MD · Principal investigator
    • Paul Phillips, MD · Sub investigator
    • Ian Elliot, MD · Sub investigator
    • Nicole Villemarette-Pittman, PhD · Sub investigator
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided — Currently there are no plans to share the data as there are no data sharing agreements in place with other institutions.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Sep 2027, 18 months after the start.

Of 424 non-industry interventional studies with no phase under Acute Pain, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's planned 18 months is above that.

Counting every sponsor, half of 430 studies reached it within 11 months; a quarter within 5 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 1, 2026
First posted
Apr 8, 2026
StartActual
Mar 1, 2026
Primary completionEst.
Sep 1, 2027
CompletionEst.
Aug 31, 2029
Last update
Apr 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07516327
Lead sponsor
Ochsner Health System
Collaborators
BREG, Inc
Responsible party
Sponsor
First posted
Apr 8, 2026
Start date
Mar 1, 2026
Primary completion
Sep 1, 2027 (estimated)
Completion
Aug 31, 2029 (estimated)
Last update
Apr 14, 2026

Study contacts

Richard Hartman, MD
Contact
mhart1@lsuhsc.edu
(504) 412-1705
Ken Bode
Contact
ken.bode@ochsner.org
504-842-1936
Michael Hartman, MD
principal investigator · Ochsner Medical Center - Kenner
Paul Phillips, MD
principal investigator · Ochsner Medical Center - Kenner

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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