“De invloed van cryotherapie op het postoperatief herstel na een schouderoperatie voor het subacromiaal pijnsyndroom.”

Rationale: Pain and early mobilization are essential factors affecting postoperative recovery
after shoulder surgery. In spite of being one of the oldest empirical treatments to relieve pain
after (surgical) musculoskeletal trauma, cryotherapy is not universally provided after shoulder
surgery. It is unknown whether postoperative cryotherapy leads to a reduction of experienced
pain, early mobilization and improved quality of life after arthroscopic shoulder surgery.

Objective: To study the effectiveness of postoperative cryotherapy on subjective patientreported
pain and shoulder function in patients operated for subacromial pain syndrome.
Study design: Randomized controlled trial, Level of evidence 1b.

Study population: The study population consists 70 patients with subacromial pain
syndrome (SAPS) who are treated with an arthroscopic debridement of the bursa.
Intervention: 35 patients (intervention group) will be allocated to computer-assisted
cryotherapy (Zamar® ZTCube) for 2 to 8 weeks after surgery. 35 patients (control group) will
be allocated to receive usual care treatment with 20mL subacromial levobupivacain
(5mg/mL, 0,5%, Chirocaine) injection after finishing the surgical procedure.

Main study endpoint: The primary study outcome is quality of life reported on the Western
Ontario Rotator Cuff index 8 weeks after surgery. Secondary outcomes are VAS for pain in
rest, VAS when elevating the arm, Simple Shoulder test, Constant Score, range of motion,
use of painkillers and return to work. Outcomes are obtained at 2 weeks, at 8 weeks, at 3
months and 1 year after surgery. Additionally, we will daily record pain and use of painkillers
until approximately 8 weeks after surgery. We will apply mixed models to investigate the
effectiveness of computer-assisted cryotherapy.

We hypothesized that computer-assisted cryotherapy leads to a significant reduction of postoperative patient-reported pain and increase in shoulder function in patients operated for patients with SAPS.

Outcomes are assessed at baseline, 2 weeks, at 8 weeks, at 3 months and 1 year after surgery.

35 patients (intervention group) will be allocated to computer-assisted cryotherapy (Zamar® ZTCube) for 2 to 8 weeks after surgery. 35 patients (control group) will be allocated to receive usual care treatment with 20mL subacromial levobupivacain (5mg/mL, 0,5%, Chirocaine) injection after finishing the surgical procedure.