- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07438821
Pain Beliefs and Functional Performance After Cosmetic Limb Lengthening Using the Lengthening Over Nail (LON) Technique (LON-PILOT)
Investigation of the Relationship Between Pain Beliefs, Pain Intensity, and Functional Performance in Individuals Undergoing Cosmetic Limb Lengthening Using the Lengthening Over Nail (LON) Technique: A Cross-Sectional Pilot Study
This pilot observational study aims to examine the relationship between pain beliefs, pain intensity, and functional performance in individuals who have undergone cosmetic lower limb lengthening surgery using the Lengthening Over Nail (LON) technique.
Seventeen healthy male participants aged between 20 and 50 years who have undergone bilateral lower limb lengthening with the LON method will be included in the study. All evaluations will be performed during a face-to-face clinical visit at the fourth postoperative week.
Pain intensity will be assessed using the Visual Analog Scale (VAS). Pain beliefs will be evaluated using the Pain Beliefs Questionnaire. Functional performance will be measured with the 6-Minute Walk Test (6MWT).
The study aims to better understand how patients' beliefs about pain may influence their perceived pain level and physical performance after cosmetic limb lengthening surgery. Findings may contribute to improving postoperative rehabilitation planning and patient management.
Study Overview
Status
Intervention / Treatment
Detailed Description
This study is designed as a descriptive, cross-sectional pilot study. The objective is to investigate the relationship between pain beliefs, pain intensity, and functional performance in individuals who have undergone cosmetic bilateral lower limb lengthening surgery using the Lengthening Over Nail (LON) technique.
Background: Cosmetic limb lengthening procedures have increasingly been performed not only for limb length discrepancy but also for aesthetic purposes. Although the surgical technique has advanced over time, postoperative functional outcomes and psychological factors influencing recovery require further investigation. Pain beliefs, which may include both organic and psychological components, can influence pain perception, coping strategies, and physical performance during rehabilitation.
Participants: Individuals aged between 20 and 50 years who have undergone bilateral lower limb lengthening surgery with the LON technique and who have completed the early postoperative rehabilitation phase will be eligible. Participants with neurological, rheumatological, systemic diseases, major postoperative complications (e.g., infection, implant failure), or conditions limiting physical activity will be excluded.
Procedures: Participants will be invited for a face-to-face clinical evaluation at the fourth postoperative week. During this visit, the following assessments will be performed:
Demographic and clinical data collection (age, sex, body weight, external fixator distraction amount)
Pain intensity assessment using the Visual Analog Scale (VAS)
Pain beliefs assessment using the Pain Beliefs Questionnaire
Functional performance evaluation using the 6-Minute Walk Test (6MWT)
All measurements will be conducted under standardized conditions and supervised by a physiotherapist.
Outcome Measures:
The primary outcomes are pain intensity (VAS score), pain beliefs (Pain Beliefs Questionnaire scores), and functional performance (6MWT distance). The study aims to determine whether significant relationships exist between pain beliefs and functional performance, as well as between pain intensity and physical capacity.
Significance:
Understanding the interaction between psychological factors and functional outcomes after cosmetic limb lengthening surgery may contribute to improving postoperative rehabilitation strategies and individualized patient management
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Fatma Cavdarci, PhD Candidate
- Phone Number: +905374590918
- Email: cvdrcftm@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age between 20 and 50 years
- Underwent bilateral lower extremity cosmetic lengthening surgery using the LON (Lengthening Over Nail) technique
- Completed postoperative rehabilitation process
- Attending routine clinical follow-up at postoperative week 4
- Able to understand and complete questionnaires
- Provided written informed consent
Exclusion Criteria:
- History of orthopedic surgery other than lower extremity lengthening
- Presence of neurological, rheumatologic, or systemic diseases affecting physical performance
- Postoperative complications such as infection, pseudoarthrosis, or implant failure
- Any condition preventing participation in physical assessment
- Incomplete clinical records
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Postoperative LON Patients
Individuals aged 20-50 years who have undergone bilateral cosmetic lower limb lengthening surgery using the Lengthening Over Nail (LON) technique and who are evaluated at the fourth postoperative week.
|
This study does not administer any therapeutic intervention.
Participants undergo standardized postoperative assessments at the fourth week after cosmetic lower limb lengthening surgery using the LON technique.
Assessments include the Visual Analog Scale (VAS) for pain intensity, the Pain Beliefs Questionnaire for evaluation of pain-related cognitions, and the 6-Minute Walk Test (6MWT) for functional performance measurement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity Measured by Visual Analog Scale (VAS)
Time Frame: Postoperative week 4
|
Pain intensity assessed using the Visual Analog Scale (VAS).
The scale ranges from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate greater pain intensity.
|
Postoperative week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Beliefs Measured by Pain Beliefs Questionnaire (PBQ)
Time Frame: Postoperative week 4
|
Pain beliefs assessed using the Pain Beliefs Questionnaire (PBQ).
The questionnaire includes organic and psychological subscales.
Items are scored on a Likert scale, with higher scores indicating stronger pain-related beliefs.
|
Postoperative week 4
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gozde Basbug, MD, PhD, Istanbul Aydın University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IAU-LON-PAIN-2026-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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