NCT06001229

Brief Summary

The purpose of this study is to assess the reliability and validity of the "Micheli Functional Scale" in the Turkish context.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

August 18, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2024

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

August 14, 2023

Last Update Submit

August 14, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Micheli Functional Scale

    Evaluates the function linked to low back pain in athletes.

    baseline and 1 week later

  • Oswestry Disability Index

    Evaluate disability due to low back pain. the index measures perceived low back pain related dysfunction. Whether the total score increaeses, the dyscfunction increases.

    baseline and 1 week later

  • Roland morris disability questionnaire

    It is a questionnaire used to evaluate the disability level of individuals with low back pain. This questionnaire, consisting of 24 items, questions the person's social life, walking, sitting, standing, getting up from a chair, climbing stairs, dressing, personal care, pain, appetite, sleep, and psychological impact. The person answers the questions with yes and no. Yes is scored as 1 point and no as 0 points. The maximum score is "24" and the minimum score is "0". As the total score increases, the level of physical exposure also increases.

    baseline and 1 week later

Secondary Outcomes (1)

  • The musculoskeletal system problem

    baseline

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

To be eligible for the study, participants must be at least 16 years old, have been practicing the same sport for a minimum of 2 years, and engage in high-effort physical activity for at least 3 days per week. Additionally, those who are able to read and write in Turkish will be included in the study.

You may qualify if:

  • years old and over
  • Having been doing the same sport for at least 2 years,
  • Participating in sports activities or activities that require a high level of effort at least 3 days a week,
  • Able to read and write Turkish

You may not qualify if:

  • Has a cognitive problem that prevents him from understanding and answering the questions or is taking a drug that may cause them,
  • Having a history of orthopedic or neurological injury or pain at a level that may prevent training or competition during the evaluation,
  • History of spine/lower and upper extremity surgery,
  • Structural deformities such as scoliosis and kyphosis,
  • Those with trap neuropathy will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 14, 2023

First Posted

August 21, 2023

Study Start

August 18, 2023

Primary Completion

June 22, 2024

Study Completion

June 22, 2024

Last Updated

August 21, 2023

Record last verified: 2023-08