Clinical trial NCT06913920: Mechanical Modalities vs. Standard Care for Edema and Pain Management After DRF Fixation
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Distal Radius Fractures
Lead sponsor: Al Hayah University In Cairo
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Edema Volume
timeFrame: Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation.
measure: Pain Intensity
timeFrame: Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation.
Secondary outcomes:
measure: Wrist/Forearm Range of Motion (ROM)
timeFrame: Measured at baseline, 6 weeks, and 3 months postoperatively.
measure: Grip Strength
timeFrame: Assessed at baseline, 6 weeks, and 3 months postoperatively.
measure: Incidence of Adverse Events
timeFrame: Continuously monitored from baseline to the 3-month follow-up.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy, Al Hayah University
Study officials:
References: