search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Continuous Passive Motion and Physical Therapy (CPM) versus Physical Therapy (PT) versus Delayed Physical Therapy (DPT) after Surgical Release for Elbow Contractures; A Prospective Randomized Controlled Trial


- candidate number25233
- NTR NumberNTR6067
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-aug-2016
- Secondary IDsNL58264.018.16 
- Public TitleContinuous Passive Motion and Physical Therapy (CPM) versus Physical Therapy (PT) versus Delayed Physical Therapy (DPT) after Surgical Release for Elbow Contractures; A Prospective Randomized Controlled Trial
- Scientific TitleContinuous Passive Motion and Physical Therapy (CPM) versus Physical Therapy (PT) versus Delayed Physical Therapy (DPT) after Surgical Release for Elbow Contractures; A Prospective Randomized Controlled Trial
- ACRONYMSET-Study
- hypothesisNo difference in range of motion at 12 months follow-up
- Healt Condition(s) or Problem(s) studiedStiff elbow
- Inclusion criteriaAge between 18 and 65 years
Flexion-extension arc of less than 100 degrees or a flexion contracture of more than 30 degrees compared to the contralateral side
Open or arthroscopic surgical treatment received
More than 6 months after trauma
Unsuccessful conservative treatment
Able to read and write in Dutch
Provision of informed consent by patient
- Exclusion criteriaInflammatory diseases (i.e. rheumatoid arthritis, psoriatic arthritis, or reactive arthritis)
Patients with any other elbow pathology (i.e. spastic contracture)
Neck pain or shoulder pain or other chronic widespread pain syndromes
Abnormalities on the X-ray
Wound problems
Inability to cooperate with a structures rehabilitation protocol
Burn-related contractures
A total elbow or interposition arthroplasty (either planned or in place)
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2017
- planned closingdate1-jan-2020
- Target number of participants90
- InterventionsPatients that are assigned to the ‘CPM’ group will receive in-hospital CPM in combination with supervised physical therapy the first three days after surgery and supervised physical therapy from day three till day 14 postoperative. Patients that are assigned to the ‘PT’ group will receive in-hospital supervised physical therapy the first three days after surgery and supervised physical therapy from day three till day 14 postoperative. Patients that are assigned to the ‘DPT’ group will receive outpatient physical therapy from postoperative day 7 till 14 and will be discharged from the hospital immediately after surgery. Physical therapy includes both active and passive exercises; moreover patients will be invited to practice at home as well.
- Primary outcomeThe primary outcome measure is active and passive ROM (flexion, extension, pronation, supination) of both elbow joints, measured with a universal goniometer, twelve months after surgery.
- Secondary outcomePatient Reported Outcome Measures (PROMs):
The Oxford Elbow Score (OES)
The Mayo Elbow Performance Index (MEPI)
The quick-‘Disabilities of Arm, Shoulder and Hand (DASH) score
The Visual Analogue pain Scale in rest and activity (VAS)
The Pain Catastrophizing Scale (PCS)
The SF-36
The WORQ questionnaire for the upper limb
- TimepointsClinical assessment will be performed preoperatively (baseline), during surgery, at day three, at day ten, eight weeks, five months and one year after surgery.
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIESMSc, PhD Jetske Viveen
- CONTACT for SCIENTIFIC QUERIESMSc, PhD Jetske Viveen
- Sponsor/Initiator Amphia hospital
- Funding
(Source(s) of Monetary or Material Support)
European Union
- Publications
- Brief summaryThe elbow is prone to stiffness after trauma. To regain functional elbow motion several conservative- and surgical treatment options are available. If conservative treatment fails, an operative release –excision and release of the scarred hypertrophic elbow capsule– of the posttraumatic stiff elbow is often performed. After surgical treatment, several rehab protocols are available, but based on evidence, there is no rehabilitation protocol superior over any of the post-operative treatment options that patients will be assigned to in this study. The following rehab protocols will be compared: 3-day in-hospital regime of CPM with PT versus 3-day in-hospital regime of early motion PT supervised by an upper extremity specialized physical therapist versus outpatient delayed PT supervised by an upper extremity specialized physical therapist from postoperative day 7 as rehabilitation protocol. By conducting this study, we hope to make a statement on the efficacy of costly in-hospital CPM in the treatment of post-operative rehabilitation for patients undergoing surgery for their posttraumatic stiff elbow. Hereby, unnecessary treatment burden for our patients (prolonged hospital stay, and lengthy CPM sessions) as well as redundant costs for society can be avoided, a more universal Evidence-Based method of treatment can be established and the quality of the care can be improved
- Main changes (audit trail)
- RECORD31-aug-2016 - 10-nov-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl