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Mechanical Modalities vs. Standard Care for Edema and Pain Management After DRF Fixation | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT06913920•Al Hayah University In Cairo

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

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.

Locations (1)

Faculty of Physical Therapy, Al Hayah University

Cairo, Egypt

Key Dates

Start Date

April 15, 2025

Primary Completion Date

January 15, 2026

Completion Date

January 15, 2026

Last Updated

April 6, 2025

Enrollment

ESTIMATED participants

Conditions

Distal Radius Fractures

Interventions

Continuous Passive Motion (CPM)

DEVICE

Intermittent Pneumatic Compression (IPC)

DEVICE

Standard Therapy Program

BEHAVIORAL

Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.

NCT06678438

Distal Radius FracturesFracture Dislocation+3 more

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RECRUITINGNA

Prednisone for CRPS in Distal Radius Fracture

NCT06453447

Complex Regional Pain SyndromesDistal Radius Fractures

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.

Prednisone for CRPS in Distal Radius Fracture

Opioid-Free Pain Treatment in Trauma Patients

Is Sensorimotor Training Effective Following a Distal Radius Fracture?

Hematoma Block Versus Bier Block for Closed Fracture Reduction

Fluidotherapy in Patients With Distal Radius Fractures