Objective of current study is to compare continuous passive motion in combination with physical therapy (CPM) versus early motion supervised physical therapy (PT) versus outpatient delayed supervised physical therapy (DPT) after surgery for…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Objective of current study is to compare continuous passive motion with
physical therapy (CPM) versus early motion supervised physical therapy (PT)
versus outpatient delayed physical therapy (DPT) as rehabilitation protocol
after surgery for posttraumatic elbow contractures in a prospective randomized
controlled trial, comparing elbow range of motion at 8 weeks, 5 months and 1
year after treatment.
Secondary outcome
Secondary objectives are QALYs and overall patient- (PROMs) and physician-based
functional recovery measured with the Mayo Elbow Performance Index (MEPI),
Quick-DASH, Oxford Elbow Score (OES) and VAS. These measurements are collected
at baseline, 8 weeks, 5 months and 1 year after treatment. Tertiary outcome
concerns patient perceived disability according to standardized measurements to
evaluate the influence of depression and pain on clinical outcome CES-D (Center
for Epidemiologic Studies Depression Scale) as well as the Pain Catastrophizing
Scale (PCS) and SF-36. These measurements are collected at baseline, 8 weeks,
5 months and 1 year after treatment.
Background summary
The elbow is prone to stiffness after trauma. To regain functional elbow motion
several conservative- and surgical treatment options are available.
Conservative treatment includes physical therapy, intra-articular injections
with corticosteroids, and a static progressive or dynamic splinting program.
If conservative treatment fails, an operative release -excision and release of
the scarred hypertrophic elbow capsule- of the posttraumatic stiff elbow is
often performed.
The best Evidence-Based rehabilitation protocol for patients after an operative
release is unknown, and therefore differs per surgeon, hospital and country to
date. Options include early- or delayed motion supervised by a physical
therapist, immediate continuous passive motion (CPM), (night) splinting, and a
static progressive or dynamic splinting program.
Study objective
Objective of current study is to compare continuous passive motion in
combination with physical therapy (CPM) versus early motion supervised physical
therapy (PT) versus outpatient delayed supervised physical therapy (DPT) after
surgery for posttraumatic elbow contractures in a prospective randomized
controlled trial (RCT).
Study design
A multi-centre randomized controlled trial and 12 months follow-up.
Intervention
The following rehab protocols are compared: regime of CPM with PT versus 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.
Study burden and risks
Based on Evidence, there is no rehabilitation protocol superior over any of the
other respective post-operative treatment options that patients will be
assigned to in this study. The different treatment options are commonly applied
rehabilitation protocols for operative release for posttraumatic elbow
stiffness. Main risk is residual stiffness for all treatment options,
irrespective of rehab strategy. However, this exposure is part of routine
clinical care for posttraumatic elbow stiffness and represents no increased
risk.
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.
Molengracht 21
Breda 4818 CK
NL
Molengracht 21
Breda 4818 CK
NL
Listed location countries
Age
Inclusion criteria
Open or arthroscopic surgical treatment received
Age between 18 and 65 years
More than 6 months after trauma
Unsuccessful conservative treatment
Flexion-extension arc less than 100 degrees
Exclusion criteria
Inflammatory diseases
Patients with any other elbow pathology
Abnormalities on the X-ray
Wound problems
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL58264.018.16 |
OMON | NL-OMON29688 |