Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06913920

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Distal Radius Fractures Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Al Hayah University

Cairo, 12311, Egypt

Location status: Recruiting

Location contact

Mohamed ElMeligie, Ph.D

CONTACT

[email protected]

01159880001 ext. +20

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous Passive Motion (CPM)

Device

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.

Intermittent pneumatic compression (IPC)

Device

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.

Standard Therapy Program

Behavioral

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.

Primary outcomes

  1. Edema Volume

    Time frame: Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation.

    Edema of the wrist/forearm will be quantitatively measured using a volumeter method. Lower volumes are indicative of reduced swelling.

  2. Pain Intensity

    Time frame: Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation.

    Pain is measured using the Numeric Pain Rating Scale (NPRS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable).

Secondary outcomes

  1. Wrist/Forearm Range of Motion (ROM)

    Time frame: Measured at baseline, 6 weeks, and 3 months postoperatively.

    Active ROM is measured using a standard goniometer. Improvements in ROM indicate better recovery of function.

  2. Grip Strength

    Time frame: Assessed at baseline, 6 weeks, and 3 months postoperatively.

    Evaluated using a calibrated dynamometer. Increased grip strength is suggestive of improved functional recovery.

  3. Incidence of Adverse Events

    Time frame: Continuously monitored from baseline to the 3-month follow-up.

    All adverse events, including skin irritation or device intolerance, will be monitored and recorded.

Sponsors and collaborators

Lead sponsor

Al Hayah University In Cairo

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.