Distal Radius FracturesNCT06913920
Mechanical Modalities vs. Standard Care for Edema and Pain Management After DRF Fixation
A study testing Continuous Passive Motion (CPM), Intermittent Pneumatic Compression (IPC) and Standard Therapy Program in people with Distal Radius Fractures, run by Al Hayah University In Cairo at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Continuous Passive Motion (CPM), Intermittent Pneumatic Compression (IPC) and Standard Therapy Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2025to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Al Hayah University
Cairo, 12311
Mohamed ElMeligie, Ph.D, 01159880001 ext. +20, mohamed.elmeligie@ahuc.edu.eg
About this study
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
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
- Being tested
- Continuous Passive Motion (CPM), Intermittent Pneumatic Compression (IPC), Standard Therapy Program
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edema Volume
Edema of the wrist/forearm will be quantitatively measured using a volumeter method. Lower volumes are indicative of reduced swelling.
Measured: 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).
Measured: Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation.
Secondary outcomes (3)
Wrist/Forearm Range of Motion (ROM)
Active ROM is measured using a standard goniometer. Improvements in ROM indicate better recovery of function.
Measured: Measured at baseline, 6 weeks, and 3 months postoperatively.
Grip Strength
Evaluated using a calibrated dynamometer. Increased grip strength is suggestive of improved functional recovery.
Measured: Assessed at baseline, 6 weeks, and 3 months postoperatively.
Incidence of Adverse Events
All adverse events, including skin irritation or device intolerance, will be monitored and recorded.
Measured: Continuously monitored from baseline to the 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al Hayah University In Cairo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913920
- Sponsor's protocol ID
- MMDRF2025-02
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06913920
- Acronym / sponsor ID
- MMDRF2025-02
- Conditions
- Distal Radius Fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Al Hayah University In CairoUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mechanical Modality Group (MMG) | Experimental | Device: Continuous Passive Motion (CPM), Device: Intermittent Pneumatic Compression (IPC), Behavioral: Standard Therapy ProgramParticipants 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 | Behavioral: Standard Therapy ProgramParticipants in the SCG will receive the standard rehabilitation program alone without the application of mechanical devices. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Passive Motion (CPM)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. | Device | Mechanical Modality Group (MMG) |
| Intermittent Pneumatic Compression (IPC)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. | Device | Mechanical Modality Group (MMG) |
| Standard Therapy ProgramProcedures: 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. | Behavioural | Mechanical Modality Group (MMG), Standard Care Group (SCG) |
Primary outcome
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).
3 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Faculty of Physical Therapy, Al Hayah University
Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Passive Motion (CPM), Intermittent Pneumatic Compression (IPC) and Standard Therapy Program in people with Distal Radius Fractures, run by Al Hayah University In Cairo at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edema Volume (time frame: Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.