|- candidate number||27118|
|- NTR Number||NTR6419|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-apr-2017|
|- Secondary IDs||P16.212, METC leiden 58789, ABR nummer|
|- Public Title||“De invloed van cryotherapie op het postoperatief herstel na een schouderoperatie voor het subacromiaal pijnsyndroom.”|
|- Scientific Title||Cryotherapy in the recovery of bursectomy for subacromial pain syndrome.
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Shoulder function, Subacromial impingement syndrome, Cuff- and stability repair of the shoulder|
|- Inclusion criteria||SAPS is defined according to the recommendations published in the guidelines for the diagnosis and treatment of SAPS of the Dutch orthopaedic association7. Emphasis is put on a combination of tests to demonstrate SAPS7, 25. The following inclusion criteria are applied: |
- Pain localized in the deltoid region
- Complaints for more than 6 months
- Unsuccessful physical therapy for at least six weeks
- Exacerbation of pain when raising the arm
- A positive Neer impingement sign, and an only temporarily effect of ultrasound guided subacromial infiltration (lidocain + corticosteroids).
- A positive Hawkins-Kennedy test
- A painful arc
- Scheduled for arthroscopic bursectomy
|- Exclusion criteria||- No informed consent is obtained|
- Language barrier
- Age <25 years
- Full-thickness rotator cuff tear
- Restriction of passive shoulder motion (i.e. frozen shoulder).
- Glenohumeral osteoarthritis
- Calcifying tendonitis
- History of a neurological disorder (e.g. stroke, Parkinson, dementia)
- Rheumatoid arthritis
- Concomitant biceps tenodesis.
- Subacromial decompression (Those patients are treated with a pain-buster).
- Clinical signs of cervical radiculopathy.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||20-apr-2017|
|- planned closingdate||1-jan-2019|
|- Target number of participants||70|
|- Interventions||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. |
|- Primary outcome||The primary study outcome is quality of life reported on the Western Ontario Rotator Cuff index 8 weeks after surgery. |
|- Secondary outcome||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. Additionally, we will daily record pain and use of painkillers until approximately 8 weeks after surgery. |
|- Timepoints||Outcomes are assessed at baseline, 2 weeks, at 8 weeks, at 3 months and 1 year after surgery. |
|- Trial web site||none|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| C.P.J. Visser|
|- CONTACT for SCIENTIFIC QUERIES|| C.P.J. Visser|
|- Sponsor/Initiator ||Alrijne ziekenhuis|
(Source(s) of Monetary or Material Support)
|- Brief summary||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.
|- Main changes (audit trail)|
|- RECORD||20-apr-2017 - 25-jun-2017|