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
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt, 12311
- Recruiting
- Faculty of Physical Therapy, Al Hayah University
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Contact:
- Mohamed ElMeligie, Ph.D
- Phone Number: +20 01159880001
- Email: mohamed.elmeligie@ahuc.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Mechanical Modality Group (MMG)
Participants in the MMG will undergo a combined intervention that utilizes mechanical modalities in addition to a standard rehabilitation program.
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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. 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. 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. |
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Active Comparator: Standard Care Group (SCG)
Participants in the SCG will receive the standard rehabilitation program alone without the application of mechanical devices.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Edema Volume
Time Frame: Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation.
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Edema of the wrist/forearm will be quantitatively measured using a volumeter method.
Lower volumes are indicative of reduced swelling.
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Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation.
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Pain Intensity
Time Frame: Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation.
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Pain is measured using the Numeric Pain Rating Scale (NPRS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable).
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Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Wrist/Forearm Range of Motion (ROM)
Time Frame: Measured at baseline, 6 weeks, and 3 months postoperatively.
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Active ROM is measured using a standard goniometer.
Improvements in ROM indicate better recovery of function.
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Measured at baseline, 6 weeks, and 3 months postoperatively.
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Grip Strength
Time Frame: Assessed at baseline, 6 weeks, and 3 months postoperatively.
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Evaluated using a calibrated dynamometer.
Increased grip strength is suggestive of improved functional recovery.
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Assessed at baseline, 6 weeks, and 3 months postoperatively.
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Incidence of Adverse Events
Time Frame: Continuously monitored from baseline to the 3-month follow-up.
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All adverse events, including skin irritation or device intolerance, will be monitored and recorded.
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Continuously monitored from baseline to the 3-month follow-up.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMDRF2025-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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