Distal Radius FractureNCT07668531
Kinesiophobia and Functional Outcomes in Distal Radius Fractures
A study testing Conservative Treatment of Distal Radius Fracture in people with Distal Radius Fracture, run by Ebru Aloğlu Çiftçi.
Trial summary
Distal radius fractures are among the most common fractures in adults and are frequently treated with closed reduction and cast immobilization. Although fracture healing is generally successful, some patients may develop fear of movement (kinesiophobia) after cast removal because of pain, reinjury concerns, or reduced… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Conservative Treatment of Distal Radius Fracture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 19 Jul 2026to 5 Feb 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: 18-65 years
- Non-intra-articular extension (AO type A) distal radius fracture
- Treatment with closed reduction and short arm cast
- No complications during treatment (redisplacement, fracture failure, etc.)
- Ability to cooperate and complete the questionnaire
Who cannot join
- History of previous fracture or neurological pathology in the same extremity
- Associated wrist, elbow, or shoulder injury
- Cognitive impairment or serious psychiatric illness
- Surgically treated distal radius fractures
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Time-Dependent Changes in Kinesiophobia and Functional Outcomes in Conservatively Treated Distal Radius Fractures
Distal radius fractures are among the most common fractures in adults and are frequently treated with closed reduction and cast immobilization. Although fracture healing is generally successful, some patients may develop fear of movement (kinesiophobia) after cast removal because of pain, reinjury concerns, or reduced confidence in using the injured wrist.
The purpose of this study is to evaluate the level of kinesiophobia in adults with conservatively treated distal radius fractures and to investigate how kinesiophobia changes over time following cast removal. The study will also examine the relationship between kinesiophobia and functional recovery.
Participants will be assessed after cast removal and again at three months following injury. Kinesiophobia, pain intensity, hand and wrist function, range of motion, grip strength, and upper extremity disability will be evaluated using standardized assessment tools. The findings may help clinicians better understand the role of movement-related fear in recovery and support the development of rehabilitation strategies aimed at improving functional outcomes after distal radius fractures.
Read the detailed description
Distal radius fractures are among the most frequently encountered upper-extremity fractures in adults and are commonly managed using conservative treatment methods, including closed reduction and cast immobilization. While successful bone healing is generally achieved, prolonged immobilization may contribute to pain, stiffness, reduced confidence in movement, and the development of kinesiophobia (fear of movement).
Kinesiophobia has been recognized as an important psychological factor that may negatively influence rehabilitation outcomes in various musculoskeletal conditions. Increased fear of movement may result in activity avoidance, delayed return to daily activities, reduced use of the affected extremity, and persistent disability. Recent studies have demonstrated associations between kinesiophobia and upper-limb functional limitations following wrist and hand injuries; however, evidence regarding the temporal evolution of kinesiophobia after conservatively treated distal radius fractures remains limited.
The primary objective of this prospective observational clinical study is to evaluate changes in kinesiophobia over time in adults with conservatively treated distal radius fractures. The secondary objective is to investigate the relationship between kinesiophobia and functional outcomes during the recovery process.
Patients aged 18-65 years with AO type A distal radius fractures treated with closed reduction and short-arm cast immobilization will be recruited from the Orthopedics and Traumatology Clinic of Marmara University Pendik Training and Research Hospital. All participants will receive standard conservative treatment. The cast will be removed at approximately five weeks after injury.
The first assessment will be performed three days after cast removal. Kinesiophobia will be evaluated using the Tampa Scale for Kinesiophobia (TSK), and pain intensity will be recorded using a Visual Analog Scale (VAS). A second assessment will be conducted at the third month following injury. At this time, kinesiophobia will be reassessed using the TSK. Functional status will be evaluated using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Hand and wrist function, grip strength, and relevant clinical parameters will also be assessed.
Inclusion criteria include adults aged 18-65 years with AO type A distal radius fractures treated conservatively with closed reduction and short-arm cast immobilization and without treatment-related complications. Exclusion criteria include previous fracture or neurological disorders affecting the same upper extremity, concomitant injuries involving the wrist, elbow, or shoulder, cognitive impairment, severe psychiatric disorders, and surgically treated distal radius fractures.
No experimental intervention, additional imaging procedure, or investigational medication will be used. All participants will provide written informed consent prior to enrollment. The study will be conducted in accordance with the ethical principles of the Declaration of Helsinki.
The results of this study are expected to improve understanding of the role of kinesiophobia in recovery after distal radius fractures and may contribute to the development of rehabilitation programs targeting psychological as well as physical aspects of recovery.
- Conditions
- Distal Radius Fracture
- Being tested
- Conservative Treatment of Distal Radius Fracture
- Keywords
- Kinesiophobia, Functional Recovery
- Medical subject headings
- Wrist Fractures, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative Treatment of Distal Radius FractureOther
Standard conservative management consisting of closed reduction followed by short-arm cast immobilization for the treatment of distal radius fractures.
| Study group | Role | What they receive |
|---|---|---|
| Female Participants | Experimental | Female adults aged 18-65 years with conservatively treated distal radius fractures who undergo prospective assessment of kinesiophobia and functional outcomes following cast immobilization. Receives: Other: Conservative Treatment of Distal Radius Fracture |
| Male Participants | Experimental | Male adults aged 18-65 years with conservatively treated distal radius fractures who undergo prospective assessment of kinesiophobia and functional outcomes following cast immobilization. Receives: Other: Conservative Treatment of Distal Radius Fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Kinesiophobia Level
Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia (TSK). Changes in TSK scores between the assessment performed 3 days after cast removal (approximately week 5) and the assessment performed at month 3 will be evaluated.
Measured: Week 5 (3 days after cast removal) and Month 3
Secondary outcomes (4)
Upper Extremity Disability
Upper extremity disability and symptoms will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire.
Measured: Month 3
Pain Intensity
Pain intensity will be assessed using a Visual Analog Scale (VAS).
Measured: Week 5 and Month 3
Grip Strength
Hand grip strength will be measured using a hand dynamometer and recorded in kilograms (kg).
Measured: Month 3
Wrist Range of Motion
Wrist flexion, extension, radial deviation, and ulnar deviation will be measured using a goniometer and recorded in degrees.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start19 Jul 2026 (estimated)
- Primary completion20 Jan 2027 (estimated)
- Study completion5 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ebru Aloğlu Çiftçi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ebru Aloğlu Çiftçi, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668531
- Sponsor's protocol ID
- MarmaraUni-02
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roman-Veas J, Gutierrez-Monclus R, Lopez-Gil JF, Valenzuela-Fuenzalida J, Araya-Quintanilla F, Gutierrez-Espinoza H, Hagert E. Baseline predictors related to functional outcomes in patients older than sixty years with complex regional pain syndrome type 1 after distal radius fracture treated conservatively: a prospective observational study. Int Orthop. 2023 Sep;47(9):2275-2284. doi: 10.1007/s00264-023-05880-0. Epub 2023 Jul 13.
PubMed 37438487
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-Dependent Changes in Kinesiophobia and Functional Outcomes in Conservatively Treated Distal Radius Fractures
- ClinicalTrials.gov ID
- NCT07668531
- Acronym / sponsor ID
- MarmaraUni-02
- Conditions
- Distal Radius Fracture
- Keywords
- Kinesiophobia, Functional Recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ebru Aloğlu ÇiftçiUniversity, hospital or other
- Study start
- 19 Jul 2026 (estimated)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 5 Feb 2027 (estimated)
- First posted
- 25 Jun 2026 (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.
Distal radius fractures are among the most common fractures in adults and are frequently treated with closed reduction and cast immobilization. Although fracture healing is generally successful, some patients may develop fear of movement (kinesiophobia) after cast removal because of pain, reinjury concerns, or reduced confidence in using the injured wrist.
The purpose of this study is to evaluate the level of kinesiophobia in adults with conservatively treated distal radius fractures and to investigate how kinesiophobia changes over time following cast removal. The study will also examine the relationship between kinesiophobia and functional recovery.
Participants will be assessed after cast removal and again at three months following injury. Kinesiophobia, pain intensity, hand and wrist function, range of motion, grip strength, and upper extremity disability will be evaluated using standardized assessment tools. The findings may help clinicians better understand the role of movement-related fear in recovery and support the development of rehabilitation strategies aimed at improving functional outcomes after distal radius fractures.
Detailed description
Distal radius fractures are among the most frequently encountered upper-extremity fractures in adults and are commonly managed using conservative treatment methods, including closed reduction and cast immobilization. While successful bone healing is generally achieved, prolonged immobilization may contribute to pain, stiffness, reduced confidence in movement, and the development of kinesiophobia (fear of movement).
Kinesiophobia has been recognized as an important psychological factor that may negatively influence rehabilitation outcomes in various musculoskeletal conditions. Increased fear of movement may result in activity avoidance, delayed return to daily activities, reduced use of the affected extremity, and persistent disability. Recent studies have demonstrated associations between kinesiophobia and upper-limb functional limitations following wrist and hand injuries; however, evidence regarding the temporal evolution of kinesiophobia after conservatively treated distal radius fractures remains limited.
The primary objective of this prospective observational clinical study is to evaluate changes in kinesiophobia over time in adults with conservatively treated distal radius fractures. The secondary objective is to investigate the relationship between kinesiophobia and functional outcomes during the recovery process.
Patients aged 18-65 years with AO type A distal radius fractures treated with closed reduction and short-arm cast immobilization will be recruited from the Orthopedics and Traumatology Clinic of Marmara University Pendik Training and Research Hospital. All participants will receive standard conservative treatment. The cast will be removed at approximately five weeks after injury.
The first assessment will be performed three days after cast removal. Kinesiophobia will be evaluated using the Tampa Scale for Kinesiophobia (TSK), and pain intensity will be recorded using a Visual Analog Scale (VAS). A second assessment will be conducted at the third month following injury. At this time, kinesiophobia will be reassessed using the TSK. Functional status will be evaluated using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Hand and wrist function, grip strength, and relevant clinical parameters will also be assessed.
Inclusion criteria include adults aged 18-65 years with AO type A distal radius fractures treated conservatively with closed reduction and short-arm cast immobilization and without treatment-related complications. Exclusion criteria include previous fracture or neurological disorders affecting the same upper extremity, concomitant injuries involving the wrist, elbow, or shoulder, cognitive impairment, severe psychiatric disorders, and surgically treated distal radius fractures.
No experimental intervention, additional imaging procedure, or investigational medication will be used. All participants will provide written informed consent prior to enrollment. The study will be conducted in accordance with the ethical principles of the Declaration of Helsinki.
The results of this study are expected to improve understanding of the role of kinesiophobia in recovery after distal radius fractures and may contribute to the development of rehabilitation programs targeting psychological as well as physical aspects of recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female Participants | Experimental | Other: Conservative Treatment of Distal Radius FractureFemale adults aged 18-65 years with conservatively treated distal radius fractures who undergo prospective assessment of kinesiophobia and functional outcomes following cast immobilization. |
| Male Participants | Experimental | Other: Conservative Treatment of Distal Radius FractureMale adults aged 18-65 years with conservatively treated distal radius fractures who undergo prospective assessment of kinesiophobia and functional outcomes following cast immobilization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age range: 18-65 years
- Non-intra-articular extension (AO type A) distal radius fracture
- Treatment with closed reduction and short arm cast
- No complications during treatment (redisplacement, fracture failure, etc.)
- Ability to cooperate and complete the questionnaire
Key exclusion criteria (4 listed)
- History of previous fracture or neurological pathology in the same extremity
- Associated wrist, elbow, or shoulder injury
- Cognitive impairment or serious psychiatric illness
- Surgically treated distal radius fractures
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 |
|---|---|---|
| Conservative Treatment of Distal Radius FractureStandard conservative management consisting of closed reduction followed by short-arm cast immobilization for the treatment of distal radius fractures. | Other | Female Participants, Male Participants |
Primary outcome
Change in Kinesiophobia Level
Time frame: Week 5 (3 days after cast removal) and Month 3
Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia (TSK). Changes in TSK scores between the assessment performed 3 days after cast removal (approximately week 5) and the assessment performed at month 3 will be evaluated.
4 secondary outcomes
Upper Extremity Disability
Time frame: Month 3
Pain Intensity
Time frame: Week 5 and Month 3
Grip Strength
Time frame: Month 3
Wrist Range of Motion
Time frame: Month 3
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 25 Jun 2026.
- Background: PubMed 37438487Roman-Veas J, Gutierrez-Monclus R, Lopez-Gil JF, Valenzuela-Fuenzalida J, Araya-Quintanilla F, Gutierrez-Espinoza H, Hagert E. Baseline predictors related to functional outcomes in patients older than sixty years with complex regional pain syndrome type 1 after distal radius fracture treated conservatively: a prospective observational study. Int Orthop. 2023 Sep;47(9):2275-2284. doi: 10.1007/s00264-023-05880-0. Epub 2023 Jul 13.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative Treatment of Distal Radius Fracture in people with Distal Radius Fracture, run by Ebru Aloğlu Çiftçi.
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 5 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: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Samir İlgaroğlu, Surgeon (+905536166156, doktorsamir.zeynal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Kinesiophobia Level (time frame: Week 5 (3 days after cast removal) and Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07668531, which also lists 1 linked publication.
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 25 Jun 2026.