Distal Radius Fractures
Conditions
Brief summary
This single-blinded, randomized controlled trial (RCT) will evaluate the added benefit of mechanical modalities (continuous passive motion (CPM) and intermittent pneumatic compression (IPC)) when integrated into standard therapy for managing postoperative edema and pain in patients undergoing distal radius fracture (DRF) fixation. The primary outcomes are edema volume (measured via volumeter) and pain intensity (Numeric Pain Rating Scale, NPRS) at 6 weeks post-operation. Secondary outcomes include wrist/forearm range of motion (ROM), grip strength, Patient-Rated Wrist Evaluation (PRWE), and adverse events.
Interventions
Materials: A CPM device configured for wrist flexion-extension with an adjustable range of motion set between 0° and 30°. Procedure: The participant's wrist is gently secured in the device. The CPM device is programmed to deliver 20 minutes of continuous, passive motion through the set range. Device settings (e.g., speed) may be modified if the participant reports pain \>4/10 on the NPRS.
Materials: An IPC sleeve designed for the forearm-to-hand region with a baseline compression setting of approximately 30 mmHg. Procedure: After CPM treatment, the IPC device is applied to the affected limb. The sleeve provides 15 minutes of intermittent compression with programmed intervals of inflation and deflation. Compression levels may be adjusted based on participant comfort and pain ratings.
BEHAVIORALStandard Therapy Program
Procedures: Active/active-assisted wrist/forearm range of motion exercises led by a certified hand/physical therapist. Progressive grip-strengthening exercises using resistance bands or putty. Manual edema management techniques, including gentle massage and manual lymphatic drainage, as well as scar mobilization if needed.
Sponsors
Al Hayah University In Cairo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants will be randomized to one of two parallel arms. The Mechanical Modality Group (MMG) receives both mechanical devices (CPM and IPC) integrated with standard therapy. The Standard Care Group (SCG) receives the same standard therapy without the addition of mechanical modalities.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Adults aged 18 years or older. Undergoing surgical treatment for distal radius fracture with stable internal fixation. Able to initiate formal rehabilitation approximately 2 weeks postoperatively. Willing and able to attend in-clinic therapy sessions at the outpatient hand therapy center.
Exclusion criteria
Unstable fixation or need for further surgical intervention. Pre-existing conditions that would significantly affect upper limb function (e.g., severe arthritis, neurological disorders). History of skin conditions or allergies that contraindicate the use of mechanical devices. Any contraindication to mechanical modalities (for example, severe peripheral vascular disease). Inability to comply with study procedures or follow-up visits. Pregnant or breastfeeding individuals.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Edema Volume | Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation. | Edema of the wrist/forearm will be quantitatively measured using a volumeter method. Lower volumes are indicative of reduced swelling. |
| Pain Intensity | Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation. | Pain is measured using the Numeric Pain Rating Scale (NPRS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wrist/Forearm Range of Motion (ROM) | Measured at baseline, 6 weeks, and 3 months postoperatively. | Active ROM is measured using a standard goniometer. Improvements in ROM indicate better recovery of function. |
| Grip Strength | Assessed at baseline, 6 weeks, and 3 months postoperatively. | Evaluated using a calibrated dynamometer. Increased grip strength is suggestive of improved functional recovery. |
| Incidence of Adverse Events | Continuously monitored from baseline to the 3-month follow-up. | All adverse events, including skin irritation or device intolerance, will be monitored and recorded. |
Countries
Egypt
Outcome results
None listed