The purpose of this study is to investigate the value of postoperative cryotherapy on subjective patients-reported pain; shoulder function and quality of life in patients operated for SAPS .
ID
Source
Brief title
Condition
- Synovial and bursal disorders
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life reported by the patient using a disease specific questionaire
(Westen Ontario Rotator Cuff Index (WORC)) 8 weeks after surgery.
Secondary outcome
Pain reported on a Visuele Analogue Scale (VAS) (baseline, 2 weeks, 8 weeks , 3
months and 1 year after surgery).
Postoperative pain reported on a numeric rating scale (NRS), first 8 weeks
after surgery using a pain-diary.
Postoperative use of painkillers, first 2 weeks after surgery using a
pain-diary.
Simple Shoulder Test (baseline, 2 weeks, 8 weeks, 3 months and 1 year after
surgery)
Constant Score (baseline, 2 weeks, 8 weeks, 3 months and 1 year after surgery)
Range of motion (baseline, 2 weeks, 8 weeks, 3 months and 1 year after surgery)
Schouderkracht (baseline, 2 weeks, 8 weeks, 3 months and 1 year after surgery)
WORC (baseline, 2 weeks, 3 months and 1 year after surgery)
Background summary
Most patient will experience pain after arthroscopic debridement of the bursa.
We know from different surgical procedures and earlier investigation of
shoulder surgery that postoperative pain predict final recovery of the
shoulder. By improving our postoperative management of pain we aim to improve
theresults of the operation.
Computer assisted cryotherapy may lead to reduction of experienced pain, and
might be a valueble option (next to to local techniques and the use of
medication). The effect of cryotherapy has been attributed the inhibition of
the inflammatory cascade, and reduction of tissue oedema or hematoma. Using a
computer we are able to cool the shoulder to a more constant temperature at
10-14 degrees Celcius, and thus potentially resulting in a greater effect of
cooling. Unfortunately, it is unknown whether postoperative cryotherapy leads
to reduced pain, early mobilization of the shoulder and improved quality of
life after arthroscopy of the shoulder.
Study objective
The purpose of this study is to investigate the value of postoperative
cryotherapy on subjective patients-reported pain; shoulder function and quality
of life in patients operated for SAPS .
Study design
Randomized clinical trial
Intervention
Groep A: Computer-assisted cryotherapie
Groep B: Usual Care with subacromial levobupivaicaine 20mL (5mg/mL, 0,5%
chirocaine).
Study burden and risks
There is a small risk of a comprised circulation of the skin, which may result
in cold urticarea (estimated risk <1%)
Theoretically, there is an elevated risk that a deprived inflammatory cascade
may increase the risk of infection.
Simon Smitweg 1
Leiderdorp 2353 GA
NL
Simon Smitweg 1
Leiderdorp 2353 GA
NL
Listed location countries
Age
Inclusion criteria
- 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/tenotomy.
- Subacromial decompression (Those patients are treated with a pain-buster).
- Clinical signs of cervical radiculopathy.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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In other registers
Register | ID |
---|---|
CCMO | NL58789.058.16 |