Postoperative Pain After Limb LengtheningLON-PILOTNCT07438821
Pain Beliefs and Functional Performance After Cosmetic Limb Lengthening Using the Lengthening Over Nail (LON) Technique
An observational study of Postoperative Pain After Limb Lengthening and Limb Lengthening, run by Istanbul Aydın University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Postoperative Pain After Limb Lengthening, Limb Lengthening
- What is being tested?
- Postoperative Functional and Pain Assessment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Jul 2026
- Phase
- Observational
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population consists of adults aged 20 to 50 years who underwent bilateral lower extremity cosmetic lengthening surgery using the LON (Lengthening Over Nail) technique and are attending routine postoperative follow-up at week 4 in a single tertiary care center.
Who may be able to join
- 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
Who cannot join
- 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
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: 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.
Read more
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.
Read the 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
- Being tested
- Postoperative Functional and Pain Assessment
- Keywords
- Lengthening Over Nail, LON technique, Cosmetic limb lengthening, Pain beliefs, 6 Minute Walk Test, Functional performance, Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative Functional and Pain AssessmentDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Postoperative Functional and Pain Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Measured by Visual Analog Scale (VAS)
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.
Measured: Postoperative week 4
Secondary outcomes (1)
Pain Beliefs Measured by Pain Beliefs Questionnaire (PBQ)
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.
Measured: Postoperative week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain After Limb LengtheningStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FATMA ÇAVDARCI, Istanbul Aydın University
- Investigators
- Gozde Basbug, MD, PhD, Principal investigator, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438821
- Sponsor's protocol ID
- IAU-LON-PAIN-2026-01
- Acronym
- LON-PILOT
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The study is a single-center academic research project conducted as part of a doctoral dissertation. Data contain sensitive health information and no data-sharing agreement or repository plan has been established.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07438821
- Acronym / sponsor ID
- LON-PILOT / IAU-LON-PAIN-2026-01
- Keywords
- Lengthening Over Nail, LON technique, Cosmetic limb lengthening, Pain beliefs, 6 Minute Walk Test, Functional performance, Postoperative pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 27 Feb 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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative LON Patients | – | Diagnostic Test: Postoperative Functional and Pain AssessmentIndividuals 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consists of adults aged 20 to 50 years who underwent bilateral lower extremity cosmetic lengthening surgery using the LON (Lengthening Over Nail) technique and are attending routine postoperative follow-up at week 4 in a single tertiary care center.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Postoperative Functional and Pain AssessmentThis 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. | Diagnostic test | Postoperative LON Patients |
Primary outcome
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.
1 secondary outcome
Pain Beliefs Measured by Pain Beliefs Questionnaire (PBQ)
Time frame: Postoperative week 4
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 27 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The study is a single-center academic research project conducted as part of a doctoral dissertation. Data contain sensitive health information and no data-sharing agreement or repository plan has been established.
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.
Gozde Basbug, MD, PhD principal investigator
Istanbul Aydın University
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain After Limb Lengthening and Limb Lengthening, run by Istanbul Aydın University.
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 6 inclusion and 5 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 27 Feb 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 Fatma Cavdarci, PhD Candidate (+905374590918, cvdrcftm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Measured by Visual Analog Scale (VAS) (time frame: Postoperative week 4). 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 27 Feb 2026.