Distal Radial Fractures in Adult Patients: 4 Weeks Versus 6 Weeks of Cast Immobilization

November 19, 2025 updated by: Mohammad Zeeshan Haider, Liaquat National Hospital & Medical College

Distal Radial Fractures in Adult Patients: 4 Weeks Versus 6 Weeks of Cast Immobilization-A Randomized Controlled Trial

Post-intervention outcomes comparing casting in distal radius fractures of four weeks versus six weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cast immobilization for 6 weeks remains the mainstay of therapy for distal radius fractures. To challenge the therapeutic time frame, participants will be randomized into two arms, and the treatment arm will undergo immobilization for 4 weeks. Outcomes will be assessed at cast removal and then at 3 and 6 months prospectively using the Quick-DASH score and the DASH score (only at 6 months).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • Liaquat National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with DRF undergoing conservative management with cast immobilization
  • Age between 18 to 50 years.

Exclusion Criteria:

  • Any syndromic patients
  • Any patients with musculoskeletal disease
  • Patients having osteoporosis
  • Post-menopausal females
  • Smokers
  • Ages less than 18 or greater than 50
  • Patients presenting with intra-articular fractures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cast immobilization for four weeks
Scotch cast immobilization for a period of four weeks applied to distal radius fractures.
Procedure: Short Arm Cast for Distal Radius Fracture for four weeks
Scotch cast immobilization below elbow for four weeks
Other Names:
  • Cast
  • Splint
Active Comparator: Cast immobilization for six weeks
Scotch cast immobilization for a period of six weeks applied to distal radius fractures
Procedure: Short Arm Cast for Distal Radius Fracture for six weeks
Scotch cast immobilization below elbow for six weeks
Other Names:
  • Cast
  • Splint

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quick Disability of Arm, Shoulder, and Hand Score (Quick DASH)
Time Frame: Four weeks (Cast Removal)
Quick Disability of Arm, Shoulder, and Hand (Quick DASH) score is calculated using a formula based on responses to an 11-item questionnaire. Scores range from 0 to 100, where 0 indicates no disability and 100 indicates the most severe disability.
Four weeks (Cast Removal)
Quick Disability of Arm, Shoulder, and Hand (Quick DASH)
Time Frame: Six weeks (Cast Removal)
Quick Disability of Arm, Shoulder, and Hand (Quick DASH) score is calculated using a formula based on responses to an 11-item questionnaire. Scores range from 0 to 100, where 0 indicates no disability and 100 indicates the most severe disability.
Six weeks (Cast Removal)
Quick Disability of Arm, Shoulder, and Hand (Quick DASH)
Time Frame: 3 months after cast removal
Quick Disability of Arm, Shoulder, and Hand (Quick DASH) score is calculated using a formula based on responses to an 11-item questionnaire. Scores range from 0 to 100, where 0 indicates no disability and 100 indicates the most severe disability.
3 months after cast removal
Quick Disability of Arm, Shoulder, and Hand (Quick DASH)
Time Frame: 6 months after cast removal
Quick Disability of Arm, Shoulder, and Hand (Quick DASH) score is calculated using a formula based on responses to an 11-item questionnaire. Scores range from 0 to 100, where 0 indicates no disability and 100 indicates the most severe disability.
6 months after cast removal
Disability of Arm, Shoulder, and Hand Score
Time Frame: 6 months post-removal of cast immobilizations
The Disability of Arm, Shoulder, and Hand Score (DASH) is a 30-item questionnaire with scores ranging from 1 to 5 for each item. The final scores are formulated from 0 to 100, where a higher score indicates greater disability and a lower score indicates little to no disability.
6 months post-removal of cast immobilizations

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Radial Deviation
Time Frame: 6 months post-cast immobilization removal
Radial deviation ranges from 15-25°. More deviation suggests more joint movement and is associated with better outcomes.
6 months post-cast immobilization removal
Ulnar Deviation
Time Frame: 6 months post-cast immobilization removal.
Ulnar deviation ranges from 30-45 °. More deviation suggests more joint movement and is associated with better outcomes.
6 months post-cast immobilization removal.
Dorsiflexion
Time Frame: 6 months post-cast immobilization removal.
Dorsiflexion ranges from 8-26 °. More flexion suggests more joint movement and is associated with better outcomes.
6 months post-cast immobilization removal.
Palmar Flexion
Time Frame: 6 months post-cast immobilization removal.
Palmar flexion ranges from 70-90 °. More flexion suggests more joint movement and is associated with better outcomes.
6 months post-cast immobilization removal.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Liaquat National Hospital & Medical College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohammad Nabeel Aamir Syed, MBBS, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R.C-LNH-Orthpedics-05/2025/52

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings