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Not yet recruitingNCT07668531Updated Jun 25, 2026

Kinesiophobia and Functional Outcomes in Distal Radius Fractures

An interventional study of Conservative Treatment of Distal Radius Fracture in Distal Radius Fracture, sponsored by Ebru Aloğlu Çiftçi. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by Ebru Aloğlu Çiftçi · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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 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.

02

Conditions studied

  • Distal Radius Fracture

Keywords

  • Kinesiophobia
  • Functional Recovery
03

In context

Wrist Fractures

330 studies on the registry are indexed under Wrist Fractures; 73 are open to participants now.

This study's planned enrollment of 100 is above the median of 62 across 265 interventional studies indexed under Wrist Fractures.

Browse Wrist Fractures studies →

Lead sponsor

Ebru Aloğlu Çiftçi is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Female Participants

    Female adults aged 18-65 years with conservatively treated distal radius fractures who undergo prospective assessment of kinesiophobia and functional outcomes following cast immobilization.

    Other: Conservative Treatment of Distal Radius Fracture

  • Experimental
    Male Participants

    Male adults aged 18-65 years with conservatively treated distal radius fractures who undergo prospective assessment of kinesiophobia and functional outcomes following cast immobilization.

    Other: Conservative Treatment of Distal Radius Fracture

Interventions

  • OtherConservative Treatment of Distal Radius Fracture

    Standard conservative management consisting of closed reduction followed by short-arm cast immobilization for the treatment of distal radius fractures.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Week 5 (3 days after cast removal) and Month 3

Secondary outcomes

  1. Upper Extremity Disability

    Upper extremity disability and symptoms will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire.

    Time frame: Month 3

  2. Pain Intensity

    Pain intensity will be assessed using a Visual Analog Scale (VAS).

    Time frame: Week 5 and Month 3

  3. Grip Strength

    Hand grip strength will be measured using a hand dynamometer and recorded in kilograms (kg).

    Time frame: Month 3

  4. Wrist Range of Motion

    Wrist flexion, extension, radial deviation, and ulnar deviation will be measured using a goniometer and recorded in degrees.

    Time frame: Month 3

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Study locations

No study locations are listed for this record.

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References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Jan 2027, 6 months later.

Of 125 non-industry interventional studies with no phase under Wrist Fractures, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 50. This study's planned 6 months is below that.

Counting every sponsor, half of 126 studies reached it within 26 months; a quarter within 16 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 19, 2026
First posted
Jun 25, 2026
StartEst.
Jul 19, 2026
Primary completionEst.
Jan 20, 2027
CompletionEst.
Feb 5, 2027
Last update
Jun 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07668531
Lead sponsor
Ebru Aloğlu Çiftçi
Responsible party
Ebru Aloğlu Çiftçi (Lecturer, Istinye University) — Sponsor-investigator
First posted
Jun 25, 2026
Start date
Jul 19, 2026 (estimated)
Primary completion
Jan 20, 2027 (estimated)
Completion
Feb 5, 2027 (estimated)
Last update
Jun 25, 2026

Study contacts

Samir İlgaroğlu, Surgeon
Contact
doktorsamir.zeynal@gmail.com
+905536166156

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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