NCT05400668

Brief Summary

The medial tibial stress syndrome (MTSS) score was originally developed in Dutch to assess severity of disease relative to patient-reported outcome, particularly patients with MTSS. The purpose of this study was to translate and cross-culturally adapt the MTSS score into Turkish and investigate its psychometric properties.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 26, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

June 20, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2022

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

May 26, 2022

Last Update Submit

November 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Medial Tibial Stress Syndrome Score

    The MTSS total score is a reliable and valid tool to assess severity in patient with MTSS. The 14-item MTSS score was designed to assessing limitations in sporting activities, pain while performing sporting activities, pain while performing activities of daily living and pain at rest. Items have four response options with descriptors for each response category. Higher item scores indicate a more severe pain or limitation and hence more severe MTSS symptoms. Participants were asked to fill out the MTSS score with their most painful shin in mind, in case of bilateral symptoms.

    Baseline (First assessment)

Secondary Outcomes (5)

  • Medial Tibial Stress Syndrome Score

    Within a 7-day period after the first assessment (Second assessment)

  • 36-Item Short Form Survey (SF-36)

    Baseline (First assessment)

  • MTSS clinical classification (Detmer's classification)

    Baseline (First assessment)

  • Evaluating the applicability of the questions

    Within a 7-day period after the first assessment (Second assessment)

  • Visual Analog Scala (VAS)

    Baseline (First assessment)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will include 48 patients diagnosed with medial tibial stress syndrome (MTSS) by the sports medicine physicians in İzmir Bozyaka Training and Research Hospital, Tepecik Training and Research Hospital and Ege University. The individuals who volunteers and meets the inclusion criteria will be included in the study.

You may qualify if:

  • Patients diagnosed with MTSS by a sports medicine physician
  • Patients aged between 18 and 75 years
  • Patients whose native language is Turkish
  • Patients who volunteered to participate in the study

You may not qualify if:

  • Having tibia fracture history,
  • Patients with suspected stress fracture or chronic compartment syndrome,
  • Pregnant and breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tepecik Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (1)

  • Demir Benli M, Winters M, Arslan AS, Ceylan E, Benli C, Ergun M. Validity and Reliability of the Turkish Version of the Medial Tibial Stress Syndrome Score. Orthop J Sports Med. 2024 Dec 5;12(12):23259671241296885. doi: 10.1177/23259671241296885. eCollection 2024 Dec.

MeSH Terms

Conditions

Medial Tibial Stress Syndrome

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesLeg InjuriesWounds and Injuries

Study Officials

  • Merve Demir Benli, MD

    Bozyaka Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Sports Medicine Physician

Study Record Dates

First Submitted

May 26, 2022

First Posted

June 1, 2022

Study Start

June 20, 2022

Primary Completion

October 6, 2022

Study Completion

October 13, 2022

Last Updated

November 22, 2022

Record last verified: 2022-11

Locations