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

NCT06913920 | Recruiting

• 1 other identifier: MMDRF2025-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Edema Volume

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

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

• Pain Intensity

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

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

Secondary Outcomes (3)

• Wrist/Forearm Range of Motion (ROM)

  Measured at baseline, 6 weeks, and 3 months postoperatively.

• Grip Strength

  Assessed at baseline, 6 weeks, and 3 months postoperatively.

• Incidence of Adverse Events

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

Study Arms (2)

Mechanical Modality Group (MMG)

EXPERIMENTAL

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

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

Standard Care Group (SCG)

ACTIVE COMPARATOR

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

Behavioral: Standard Therapy Program

Interventions

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.

Mechanical Modality Group (MMG)

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.

Mechanical Modality Group (MMG)

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.

Mechanical Modality Group (MMG); Standard Care Group (SCG)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al Hayah University In Cairo: lead

Study Sites (1)

Faculty of Physical Therapy, Al Hayah University

Cairo, 12311, Egypt

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Interventions

Motion Therapy, Continuous Passive; Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Musculoskeletal Manipulations; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to one of two parallel arms. The Mechanical Modality Group (MMG) receives both mechanical devices (CPM and IPC) integrated with standard therapy. The Standard Care Group (SCG) receives the same standard therapy without the addition of mechanical modalities.

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 6, 2025
• Study Start: April 15, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)