Self-management exercise regimen are clinically non-inferior compared to supervised hand-therapy. The total costs of self-management exercise regimes are lower.
ID
Source
Brief title
Condition
- Fractures
Synonym
Health condition
volar plate injury, PIP dislocation, hyperextension injury of PIP
Research involving
Sponsors and support
Intervention
- Movement therapy
Outcome measures
Primary outcome
Function, pain and disability expressed as change on the Michigan Hand Questionnaire Score (MHQ) after three months.
Secondary outcome
Pain as indicated on a Visual Analogue Scale (VAS), Well-being with the Patient Specific Functional and pain Scales (PSFS), Understanding medical information with the Newest Vital Sign- Dutch language version (NVS-D), Total active range of motion of the hand (TAM), Patient satisfaction score, Patient expectation, quality of life, complications, work-absence and cost effectiveness and measurement of health status with the EQ-5D-5L.
Background summary
Approximately 10 000 patients have dorsal dislocations or hyperextension injuries with a volar plate avulsion fracture fragment of the proximal interphalangeal joint in the Netherlands yearly. These types of finger injuries are often caused by ball sports due to hyperextension or axial loading mechanisms. Most of these injuries are stable following reduction. A stable congruent joint following trauma allows for early motion with a dorsal block splint. Arora et al. published a retrospective study on treatment of dorsolateral dislocation of the PIP joint and concluded that early active motion in a dorsal block splint in almost full extension leads to significantly superior results in the range of motion compared to static splinting. A feared complication following hyperextension injuries with volar plate avulsion or PIP dislocations is the development of a flexion contracture. The Dutch guideline committee for hand fractures states that all patients with hyperextension injuries should be referred to a hand therapist within one week. Conversely, there is no evidence that hand-physiotherapy leads to better outcomes than self-management exercise regimen.
Study objective
Self-management exercise regimen are clinically non-inferior compared to supervised hand-therapy. The total costs of self-management exercise regimes are lower.
Study design
MHQ: 1,6 week, 3,12 months
VAS: 1,6 week, 3,6,12 months
PSFS: 1,6 week, 3,12 months
NVS-dlv: 1 week
TAM: 1,6 week 3 months
Patient satisfaction: 1,6 week, 3,6,12 months
Patient expectation: 1 week
Achievement of expectation: 3, 12 months
EQ-5D-5L: 1,6 weeks, 3,6,12 months
CEA: 6 weeks, 3,6,12 months
Intervention
The intervention group will be treated with a well-defined self-management exercise regimen, within 1 week after injury. Additionally, patients will receive a dorsal block splint in zero degrees of flexion for the period of four weeks, starting at the emergency department conform the recommendation by The Dutch Guideline committee for hand fractures.
In the control group, the hand-physiotherapist decides what frequency of follow-up is needed. Hand therapists will be briefed in advance and they will follow a standard protocol for this type of injury. Hand physiotherapy starts within 1 week after injury, according to the Dutch guidelines. Additionally, patients will receive a dorsal block splint in zero degrees of flexion for the period of four weeks, starting at the emergency department conform the recommendation by The Dutch Guideline committee for hand fractures.
Age
Inclusion criteria
a. Population (base)
- All adult patients with a PIP hyperextension injury leading to a complete dorsal dislocation, objectified by a doctor at the emergency department or by radiograph at the emergency department. - All adult patients with PIP hyperextension injury leading to a volar plate avulsion, objectified by an avulsion fracture of the proximal volar part of the mid phalanx (< 40% of the joint) on a radiograph at the emergency department.
b. Inclusion criteria
- Patients 18 years and older
- Single PIP hyperextension injuries or dislocation of the fingers
- A stable joint after reduction, assessed by dorsal, volar, and lateral stress on the PIP joint in extension and 30 degrees of PIP flexion.
- Standard conservative treatment with a dorsal block splint in 0 degrees extension for four weeks.
- Avulsion fracture of the proximal volar part of the mid phalanx (< 40% of the joint)* on a radiograph at the emergency department.
- Standardized Eaton classification: type I,II,IIIa
Exclusion criteria
An avulsion fracture of the PIP joint, >40% of the articular surface
- Re-displacement during digit motion
- An unstable joint after reduction assessed by dorsal, volar, and lateral stress on the PIP joint, requiring operative treatment
- Irreducible dislocations
- Suspicion for interposition of the volar plate
- Operation indication
- Hyperextension injuries of the IP of the thumb
- Multiple PIP hyperextension injuries or dislocation of the fingers
- Patients with impaired hand function prior to injury due to arthrosis/neurological disorders of the upper limb
- Multiple trauma patients (Injury Severity Score (ISS) ¡Ý16)
- Other injuries in the ipsilateral extremity
- Insufficient comprehension of the Dutch language to understand a rehabilitation program and other treatment information as judged by the attending physician
- Patients suffering from disorders of bone metabolism other than osteoporosis (i.e. Paget¡¯s disease, renal osteodystrophy, osteomalacia
- Patients suffering from connective tissue disease or (joint) hyper-flexibility disorders such as Marfan¡¯s, Ehler Danlos or other related disorders.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6383 |
| NTR-old | NTR7655 |
| CCMO | NL67400.100.18 |
| OMON | NL-OMON55623 |