Mechanical Modalities vs. Standard Care for Edema and Pain Management After DRF Fixation (NCT06913920) | Clinical Trial Compass
RecruitingNot Applicable
Mechanical Modalities vs. Standard Care for Edema and Pain Management After DRF Fixation
Egypt50 participantsStarted 2025-04-15
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Edema Volume
Timeframe: Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation.
2
Pain Intensity
Timeframe: Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation.