A Randomized Controlled Trial Comparing Traditional Physiotherapy vs Telerehabilitation After Volar Plating of Distal Radius Fracture: a Study Protocol
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Orthopedic Procedures
- Sponsor
- Töölö Hospital
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Patient-Rated Wrist Evaluation (PRWE)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Trial purpose is to research the outcome comparing traditional physiotherapy vs telerehabilitation after volar plating of distal radius fracture.
Patients with distal radius fracture that meet the operative criteria set by the Finnish Current Care guidelines are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo operative treatment and traditional physiotherapy vs telerehabilitation.
Baseline data is collected preoperatively and patients are followed at 1, 3 and 12 months after enrollment. The primary end-point is 3 months and the primary outcome is the Patient-Rated Wrist Evaluation (PRWE).
Investigators
Samuli Aspinen
Principal investigator
Hospital District of Helsinki and Uusimaa
Eligibility Criteria
Inclusion Criteria
- •Distal radius fracture, which applies the surgical requirements
- •age between 18 to 65 years
- •Non concomitant injuries including ligament injuries and distal ulna fractures, however ulnar styloid avulsion is accepted
- •No significant comorbidities
- •No previous problems with the examined hand
- •Ability to understand Finnish fluently
Exclusion Criteria
- •High energy or multiple injuries
- •Open fractures
- •Injury of both upper extremities
- •Other operative injury on the same side
- •Rheumatoid arthritis of other inflammatory joint disease
- •Heavy smoker (over 20 cigarettes per day)
- •Disease of medication slowing ossification
- •Alcohol or drug abuse
- •Psychiatric disorder with poor treatment balance
- •Neurological disorder which affects the function of the injured extremity
Outcomes
Primary Outcomes
Patient-Rated Wrist Evaluation (PRWE)
Time Frame: 12 months
The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)
Secondary Outcomes
- Cost-utility analysis(12 months)
- Grip strength(12 months)
- Quick Disabilities of the arm, shoulder, and hand(12 months)
- Pain (Visual Analogue Scale)(12 months)
- Wrist range of motion (ROM)(12 months)
- Adverse events(12 months)
- Global improvement(12 months)
- Patient-rated Quality of Life (EQ-5D)(12 months)