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

Al Hayah University In Cairo

Status: Enrolling

Conditions: Distal Radius Fractures

Treatments: Device: Intermittent Pneumatic Compression (IPC); Device: Continuous Passive Motion (CPM); Behavioral: Standard Therapy Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06913920

MMDRF2025-02

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Mechanical Modality Group (MMG)

Experimental group

Description:

Participants in the MMG will undergo a combined intervention that utilizes mechanical modalities in addition to a standard rehabilitation program.

Treatment:

Behavioral: Standard Therapy Program

Device: Continuous Passive Motion (CPM)

Device: Intermittent Pneumatic Compression (IPC)

Standard Care Group (SCG)

Active Comparator group

Description:

Participants in the SCG will receive the standard rehabilitation program alone without the application of mechanical devices.

Treatment:

Behavioral: Standard Therapy Program