Recruitment and consent
Patients with distal radius fractures will be initially managed on the emergency department. Using the criteria for displacement: distal radial fractures with initial dorsal angulation up to 15° and axial radial shortening of not more than 5 mm. Patients will be included if closed reduction of the distal radius fracture is not necessary according to these criteria for misalignment.
They will receive written information and a consent form from the attending physician, the clinical investigator or a research assistant. After providing informed consent, eligible patients will be randomized within one week. An independent research assistant will perform concealed permuted block randomization using a computer-generated randomization schedule after stratification for fracture type, gender and age. Allocation will be at random to four blocks.
Outcome measures
The primary outcome measure is the Quick-DASH (Disabilities of the Arm, Shoulder and Hand) score [
17], which reflects both function and pain and PRWE (Patient Related Wrist Evaluation) [
18].
The DASH Outcome Measure is a validated 30-item, self-reported questionnaire designed to help describe the disability experienced by people with upper-limb disorders and also to monitor changes in symptoms and function over time [
17].
The Quick-DASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the Quick-DASH uses 11 items (scored 1–5) to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The right and left elbow will be assessed separately. At least 10 of the 11 items must be completed for a score to be calculated. The scores will be transformed to a 0–100 scale for easy comparison. A higher score indicates greater disability.
Like the DASH, the Quick-DASH contains 2 optional modules to measure symptoms and function in athletes, performing artists and other workers whose jobs require a high degree of physical performance. These optional models are scored separately; each contains four items, scored 1–5. All items must be completed for a score to be calculated.
PRWE score is the most responsive instrument for evaluating the outcome in patients with distal radius fractures [
18].
The secondary outcome measures are:
2.
Pain (assessed by the VAS scale).
3.
Complications: dislocation, complex regional pain syndrome and mal/nonunion.
Pain level will be determined using a 10-point Visual Analog Scale (VAS), in which zero implies no pain and ten implies the worst possible pain.
ROM will be measured on both sides using a goniometer.
In addition to the outcome variables mentioned above, the following data will be collected:
a)
Intrinsic variables (baseline data): age, gender, American Society of Anesthesiologists’ ASA classification, tobacco consumption, alcohol consumption, comorbidity, social status/household composition, dominant side, and medication use.
b)
Injury related variables: affected side, mechanism of injury.
c)
Intervention-related variables: time between injury and start of physical therapy and number of physical therapy sessions.
Study procedures
After inclusion, all patients will be followed for one year in total. Clinical assessments will occur at the time of admission (ED), one week (3-10-day window), three weeks (11-28-day window) or five weeks (4-8-week window), six weeks (4-8-week window), three months (11-15-week window), six months (5-7-month window), and 12 months (12-14-month window) after start of treatment.
At each FU visit, the research coordinator or research assistant will ascertain patient status (i.e., secondary interventions, adverse events/complications, deaths) and will verify information within medical records.
At each FU visit, the patients will be asked to indicate the pain level on a VAS.
At each visit from six weeks onwards, the ROM of the wrist will be measured using a goniometer by a doctor blinded for the treatment method. In addition, patients will be asked to complete the questionnaires relating to disability (Quick-DASH score including optional modules, PRWE Score), and healthcare consumption.
Plain X-rays of the wrist will be made at the time of presentation in the hospital (ED), and at the follow-up visit after 6 weeks three months, six months and one year. The X-ray at 12 months will be taken in order to determine the grade of degenerative joint changes.
Time to define the presence of a malunion will be at three months. Intention-to-treat principle will be maintained (see Figure
2).
X-ray: control X-ray according to standard guidelines, assessment using Lidström score [
19].
Function: functional assessment using functional outcome scores, range of motion, pain assessment using VAS scale.
ED = Emergency Department, D = days, W = weeks, M = months.
Sample size
The primary outcome will be the QuickDASH score of which the minimal clinically important difference is 14 points. Based on a difference of 14 points, the sample size of 30 patients per treatment group was calculated with a power (1-β) of 80 percent and a type I error (α) of 5 percent, allowing for 10 percent drop-out. In total 70 patients will be included.