The Turkish Version of the Medial Tibial Stress Syndrome Score

Medial Tibial Stress Syndrome Clinical Trial

Official title:

The Reliability and Validity of the Turkish Version of the Medial Tibial Stress Syndrome (MTSS-Tr) Score

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05400668
• Other study ID #: mdbenli
• Status: Completed
• Start date: June 20, 2022
• Est. completion date: October 13, 2022

Study information

• Verified date: November 2022
• Source: Bozyaka Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The medial tibial stress syndrome (MTSS) score was originally developed in Dutch to assess severity of disease relative to patient-reported outcome, particularly people with MTSS. The purpose of this study was to translate and cross-culturally adapt the MTSS score into Turkish and investigate its psychometric properties. Fourty-eight individuals with MTSS will include. Within a 7-day period after the first assessment, the participants completed the Turkish version of the MTSS score to evaluate test-retest reliability.

Cronbach's alpha (α) was used to assess internal consistency. Construct validity was examined total score of PCS domain of SF-36-Tr with MTSS-Tr total score in the first visit. Concurrent validity was examined by evaluating the relationship between pain level and Detmer's classification with MTSS score in the first visit. The pain level of the patient assessed with visual analog scale (VAS) score.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 13, 2022
• Est. primary completion date: October 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Having tibia fracture history,

• Patients with suspected stress fracture or chronic compartment syndrome,

• Pregnant and breastfeeding women

Related Conditions & MeSH terms

• Medial Tibial Stress Syndrome
• Syndrome

Locations

Country	Name	City	State
Turkey	Tepecik Training and Research Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Bozyaka Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Within a 7-day period after the first assessment (Second assessment)
Secondary	36-Item Short Form Survey (SF-36)	The SF-36 is widely used to measure a variety of domains, including pain and limitations while performing activities of daily living, and also in musculoskeletal and sports medicine-related research. Short Form Health Survey (SF-36), which includes two main domains, the physical component score (PCS) and the mental component score (MCS), has been widely used worldwide in studies to assess the health status burden of people and consists of 36 questions that are clustered to yield eight health status scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health, reported health transition. The total score of PCS and MCS from 0 to 100, with higher scores indicating higher levels of function and/or better health.	Baseline (First assessment)
Secondary	MTSS clinical classification (Detmer's classification)	Physical examination evaluates the localization of pain at the posteromedial edge of tibia. According to the MTSS classification created by Detmer et al.; it is classified as Type 1 in the presence of tenderness only on the tibia, Type 2 in the posteromedial of the tibia at the junction of the periosteum and fascia, and Type 3 in the presence of tenderness in the deep compartment muscles of the posterior tibia.	Baseline (First assessment)
Secondary	Evaluating the applicability of the questions	Participants evaluate the MTSS questionnaire with additional three Likert-type questions in the first assessment. In the continuation of these questions, there is also a comment section about the simplicity of filling out the survey and the convenience and usefulness of this survey.	Within a 7-day period after the first assessment (Second assessment)
Secondary	Visual Analog Scala (VAS)	Pain is graded from 0 to 10 by Visual Analog Scala (VAS). 0 indicates the least pain and 10 the most pain. The patient gives a value on this scale for the pain she/he feels.	Baseline (First assessment)