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A Two-Arm, Single-Blinded Randomized Controlled Trial Evaluating Mechanical Modalities Combined With Standard Therapy Versus Standard Therapy Alone for Edema and Pain Management After Distal Radius Fracture Fixation
Led by Al Hayah University In Cairo · Updated on 2025-04-06
50
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the added benefit of mechanical devices combined with standard therapy for managing swelling and pain after surgery to fix broken wrists (distal radius fractures). This study is a single-blinded, randomized controlled trial that aims to compare the effects of these mechanical methods with standard care alone. Key outcomes being measured include the amount of swelling and pain levels at six weeks after surgery, along with wrist and forearm movement, hand strength, patient-reported wrist function, and any side effects. Participants are randomly assigned to one of two groups. One group receives a combination of mechanical treatments—continuous passive motion (CPM) using a device that gently moves the wrist, and intermittent pneumatic compression (IPC) using a sleeve that applies pressure to the arm—alongside a standard rehabilitation program. The other group receives the standard therapy alone, which includes guided exercises and manual techniques for swelling and scar management. CPM is applied for 20 minutes, followed by 15 minutes of IPC, with adjustments made for comfort and pain. During the study, participants attend therapy sessions at an outpatient hand therapy center starting about two weeks after surgery. Assessments include measuring swelling volume and pain at baseline and six weeks post-operation, and evaluating wrist/forearm range of motion and grip strength at baseline, six weeks, and three months. Researchers also continuously monitor any adverse events throughout the three-month follow-up period. The total participation duration includes initial assessments and follow-ups over three months.
CONDITIONS
Brief Title
Mechanical Modalities vs. Standard Care for Edema and Pain Management After DRF Fixation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Undergoing surgical treatment for distal radius fracture with stable internal fixation
- Able to start formal rehabilitation about 2 weeks after surgery
- Willing and able to attend outpatient hand therapy sessions
You will not qualify if you...
- Unstable fixation or need for further surgery
- Pre-existing conditions significantly affecting upper limb function, such as severe arthritis or neurological disorders
- History of skin conditions or allergies that prevent use of mechanical devices
- Contraindications to mechanical modalities, such as severe peripheral vascular disease
- Inability to follow study procedures or attend follow-up visits
- Pregnant or breastfeeding individuals
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 weeks starting about 2 weeks after surgery
Participants receive either mechanical modalities combined with a standard rehabilitation program or the standard rehabilitation program alone to manage edema and pain after distal radius fracture fixation.
Weekly outpatient hand therapy visits
Duration - Up to 3 months postoperatively
Participants are monitored for wrist and forearm function, grip strength, pain, edema, and adverse events after completing the treatment phase.
Assessments at 6 weeks and 3 months post-operation
Trial Site Locations
Total: 1 location
1
Faculty of Physical Therapy, Al Hayah University
Cairo, Egypt, 12311
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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