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Mechanical Modalities vs. Standard Care for Edema and Pain Management After DRF Fixation

NCT06913920 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-04-06

No results posted yet for this study

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.

Conditions

  • Distal Radius Fractures

Interventions

DEVICE

Continuous Passive Motion (CPM)

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.

DEVICE

Intermittent Pneumatic Compression (IPC)

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.

BEHAVIORAL

Standard 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 & Collaborators

  • Al Hayah University In Cairo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2026-01-15
Completion
2026-01-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06913920 on ClinicalTrials.gov