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

NCT ID: NCT06913920

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2026-01-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mechanical Modality Group (MMG)

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

Group Type: EXPERIMENTAL

Continuous Passive Motion (CPM)

Intervention Type: 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)

Intervention Type: 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

Intervention Type: 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.

Standard Care Group (SCG)

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

Group Type: ACTIVE_COMPARATOR

Standard Therapy Program

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al Hayah University In Cairo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Faculty of Physical Therapy, Al Hayah University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Mohamed ElMeligie, Ph.D

Role: primary

mohamed.elmeligie@ahuc.edu.eg

01159880001 ext. +20

Other Identifiers

MMDRF2025-02

Identifier Type: -

Identifier Source: org_study_id