Health TrialsbyHealthPanel

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

ConditionDistal Radius Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAl Hayah University In Cairo

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Mechanical Modality Group (MMG)Experimental treatment 3 interventions
Group B: Standard Care Group (SCG)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Edema Volume

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

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

Pain Intensity

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

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

Secondary outcomes

1

Wrist/Forearm Range of Motion (ROM)

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

Time frame
Measured at baseline, 6 weeks, and 3 months postoperatively.
2

Grip Strength

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

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

Incidence of Adverse Events

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

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

Other outcomes

Sponsors and contacts

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Al Hayah University In Cairo

Lead sponsor

Source ClinicalTrials.gov
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