Medial Tibial Stress SyndromeNCT05400668
The Turkish Version of the Medial Tibial Stress Syndrome Score
An observational study of Medial Tibial Stress Syndrome, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Medial Tibial Stress Syndrome
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2022to 13 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Having tibia fracture history,
- Patients with suspected stress fracture or chronic compartment syndrome,
- Pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Reliability and Validity of the Turkish Version of the Medial Tibial Stress Syndrome (MTSS-Tr) Score
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.
Read the detailed 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.
- Conditions
- Medial Tibial Stress Syndrome
- Medical subject headings
- Medial Tibial Stress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (First assessment)
Secondary outcomes (5)
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.
Measured: Within a 7-day period after the first assessment (Second assessment)
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.
Measured: Baseline (First assessment)
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.
Measured: Baseline (First assessment)
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.
Measured: Within a 7-day period after the first assessment (Second assessment)
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.
Measured: Baseline (First assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start20 Jun 2022
- Primary completion6 Oct 2022
- Study completion13 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medial Tibial Stress SyndromeStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Demir Benli, Bozyaka Training and Research Hospital
- Investigators
- Merve Demir Benli, MD, Study director, Bozyaka Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400668
- Sponsor's protocol ID
- mdbenli
- Status last verified
- Nov 2022
- First submitted
- 26 May 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39640185
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability and Validity of the Turkish Version of the Medial Tibial Stress Syndrome (MTSS-Tr) Score
- ClinicalTrials.gov ID
- NCT05400668
- Acronym / sponsor ID
- mdbenli
- Conditions
- Medial Tibial Stress Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 13 Oct 2022 (actual)
- First posted
- 1 Jun 2022 (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.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Having tibia fracture history,
- Patients with suspected stress fracture or chronic compartment syndrome,
- Pregnant and breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Medial Tibial Stress Syndrome Score
Time frame: Baseline (First assessment)
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.
5 secondary outcomes
Medial Tibial Stress Syndrome Score
Time frame: Within a 7-day period after the first assessment (Second assessment)
36-Item Short Form Survey (SF-36)
Time frame: Baseline (First assessment)
MTSS clinical classification (Detmer's classification)
Time frame: Baseline (First assessment)
Evaluating the applicability of the questions
Time frame: Within a 7-day period after the first assessment (Second assessment)
Visual Analog Scala (VAS)
Time frame: Baseline (First assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Derived from this study: PubMed 39640185Demir 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.
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. This study is not recruiting at the moment.
Merve Demir Benli, MD study director
Bozyaka Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medial Tibial Stress Syndrome, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medial Tibial Stress Syndrome Score (time frame: Baseline (First assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05400668, which also lists 1 linked publication.
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 22 Nov 2022.