---
title: Mechanical Modalities vs. Standard Care for Edema and Pain Management After DRF Fixation
nct_id: NCT06913920
overall_status: RECRUITING
phase: NA
sponsor: Al Hayah University In Cairo
study_type: INTERVENTIONAL
primary_condition: Distal Radius Fractures
countries: Egypt
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06913920.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06913920"
ct_last_update_post_date: 2025-04-06
last_seen_at: "2026-05-12T06:56:11.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT06913920](https://clinicaltrials.gov/study/NCT06913920)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Al Hayah University In Cairo
- **Conditions:** Distal Radius Fractures
- **Start Date:** 2025-04-15
- **Completion Date:** 2026-01-15
- **CT.gov Last Update:** 2025-04-06

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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.
- **Standard Care Group (SCG)** (ACTIVE_COMPARATOR) — Participants in the SCG will receive the standard rehabilitation program alone without the application of mechanical devices.

## 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.
- **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.

## Primary Outcomes

- **Edema Volume** _(time frame: Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation.)_ — Edema of the wrist/forearm will be quantitatively measured using a volumeter method. Lower volumes are indicative of reduced swelling.
- **Pain Intensity** _(time frame: Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation.)_ — Pain is measured using the Numeric Pain Rating Scale (NPRS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable).

## Secondary Outcomes

- **Wrist/Forearm Range of Motion (ROM)** _(time frame: Measured at baseline, 6 weeks, and 3 months postoperatively.)_
- **Grip Strength** _(time frame: Assessed at baseline, 6 weeks, and 3 months postoperatively.)_
- **Incidence of Adverse Events** _(time frame: Continuously monitored from baseline to the 3-month follow-up.)_

## Locations (1)

- Faculty of Physical Therapy, Al Hayah University, Cairo, Egypt — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.faculty of physical therapy, al hayah university|cairo||egypt` — added _(2026-05-12)_

---

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