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CompletedNCT07922707Updated Nov 6, 2026

Cryotherapy in Arthroscopic Rotator Cuff Repair

An interventional study of continuous cryotherapy device and standard ice pack in Rotator Cuff, sponsored by Gianluca Caprili. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Gianluca Caprili · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Apr 2024, 2 years 6 months ago, and no results have been posted to the registry.
  • Registered 3 years 7 months after the study started (first participant enrolled Apr 2023, registered Nov 2026).
Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

to assess the impact of a modern continuous cryotherapy device on pain intensity and postoperative analgesic consumption in patients undergoing arthroscopic rotator cuff repair.

Read the detailed description

Fifty patients treated with pre- and postoperative cryotherapy using a continuous cryotherapy device (case group) were compared with 43 control patients treated with standard ice packs postoperatively. Pain intensity was assessed using the Visual Analogue Scale (VAS) at baseline (VAS 0), 20 days (VAS 20), and 90 days (VAS 90) postoperatively. Analgesic use during the first postoperative week was recorded. Statistical analysis included Wilcoxon rank-sum tests and repeated-measures ANOVA.

02

Conditions studied

  • Rotator Cuff

Keywords

  • continuous cryotherapy
  • rotator cuff repair
  • pain control
  • analgesic consumption
03

In context

Lead sponsor

This is the only study on the registry with Gianluca Caprili as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 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

  • more than 18 years old, surgically repairable rotator cuff tear

Exclusion criteria

Exclusion Criteria:

  • less than 18 years old, previous surgery on ipsilateral shoulder, glenohumeral instability or osteoarthritis, Raynaud's syndrome, metabolic diabetes, cryoglobulinemia arteriosclerosis coagulation disorders
05

Study design

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

Study arms

  • Active comparator
    continuous cryotherapy device

    modern continuous cryotherapy device

    Device: continuous cryotherapy device

  • Sham comparator
    standard ice pack

    standard ice pack

    Device: standard ice pack

Interventions

  • Devicecontinuous cryotherapy device

    continuous cryotherapy device applicated postoperatively, at baseline (0 days) 20 days, 90 days

  • Devicestandard ice pack

    standard ice pack applied

06

What researchers measure

Primary outcomes

  1. VAS score

    VAS score (pain) at 0, 20 and 90 days postop, using a continuous cryotherapy device vs standard ice pack

    Time frame: from enrollment to the end of treatment at 90 days

  2. analgesic consumption

    analgesic consumption at 0, 20 and 90 days postop, using a continuous cryotherapy device vs standard ice pack

    Time frame: from enrollment to 90 days

07

Study locations

1 site
  • Ospedale San Pietro Igneo
    Fucecchio, Firenze 50054, Italy
08

References and documents

Publications

  • Barlas D, Homan CS, Thode HC Jr. In vivo tissue temperature comparison of cryotherapy with and without external compression. Ann Emerg Med. 1996 Oct;28(4):436-9. doi: 10.1016/s0196-0644(96)70011-2. PubMed 8839531 ↗
  • Lehmann JF, Warren CG, Scham SM. Therapeutic heat and cold. Clin Orthop Relat Res. 1974 Mar-Apr;(99):207-45. doi: 10.1097/00003086-197403000-00028. No abstract available. PubMed 4133064 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided — privacy concerning

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2023 to primary completion in Apr 2024, 12 months.

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

Registered
Nov 2, 2026
First posted
Nov 6, 2026
StartActual
Apr 1, 2023
Primary completionActual
Apr 30, 2024
CompletionActual
Jul 31, 2024
Last update
Nov 6, 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.
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07922707
Lead sponsor
Gianluca Caprili
Collaborators
DonJoy Orthopedics
Responsible party
Gianluca Caprili (Dr, Azienda USL Toscana Centro) — Sponsor-investigator
First posted
Nov 6, 2026
Start date
Apr 1, 2023
Primary completion
Apr 30, 2024
Completion
Jul 31, 2024
Last update
Nov 6, 2026

Study contacts

michele novi, dr
principal investigator · Azienda USL Toscana Centro

Oversight

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

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This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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