RecruitingNot ApplicableNCT06913920

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

A Two-Arm, Single-Blinded Randomized Controlled Trial Evaluating the Effectiveness of Mechanical Modalities Combined With Standard Therapy Versus Standard Therapy Alone for Edema and Pain Management After Distal Radius Fracture Fixation

Sponsor

Al Hayah University In Cairo

Enrollment

50 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

Distal Radius Fractures

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

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 Criteria4

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.

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Interventions

DEVICEContinuous 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.

DEVICEIntermittent 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.

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.