NCT06913920 Mechanical Modalities vs. Standard Care for Edema and Pain Management After DRF Fixation
| NCT ID | NCT06913920 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Al Hayah University In Cairo |
| Condition | Distal Radius Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2026-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-04-15 with a primary completion date of 2026-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT06913920 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Distal Radius Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06913920 currently recruiting?
Yes, NCT06913920 is actively recruiting participants. Visit ClinicalTrials.gov or contact Al Hayah University In Cairo to inquire about joining.
Where is the NCT06913920 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT06913920 clinical trial?
NCT06913920 is sponsored by Al Hayah University In Cairo. The trial plans to enroll 50 participants.