Musculoskeletal DiseasesNCT05496621
Validity and Reliability of Turkish Version of Keele STarT MSK Tool
A study testing Questionnaire in people with Musculoskeletal Diseases, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the usability of the Turkish version of the Keel Start Tool as a valid and reliable method in groups with 5 different types of musculoskeletal pain (knee, neck, shoulder, back, multiple painful areas). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 1 Nov 2019
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be 18 years or older.
- The location of MSC pain must be one of the 5 regions. These 5 regions; knee, shoulder, back, neck, multi-region.
- Volunteering to participate in the study
- The patient's pain must be chronic. chronic pain; If there is general agreement on the definition of pain today, the recognition of pain as a disease is controversial. Depending on their duration, different types of pain are now classified as chronic pain, and the generally accepted definition is "pain that continues after a normal recovery period."
- The patient's Mini mental test score must be 23 and above. The mini mental state examination is scored on a scale of 0-30 with >25 points interpreted as normal cognitive status.
Who cannot join
- Those with serious pathological symptoms
- Joint infection
- Cancer
- Rheumatoid arthritis
- Spondyloarthropathy
- Polymyalgia
Show all 19Show fewer
- Inflammatory arthropathy
- Crystal disease
- Gout
- Those with severe and persistent mental health problems
- Having a diagnosis of dementia
- Those with a terminal illness diagnosis
- Those who have recently experienced trauma or bereavement
- Those who cannot communicate in Turkish
- Those with neurological problems
- Suspected fracture
- Those with joint inflammation
- Those with neuromuscular disease
- Those with systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the usability of the Turkish version of the Keel Start Tool as a valid and reliable method in groups with 5 different types of musculoskeletal pain (knee, neck, shoulder, back, multiple painful areas). When the literature is examined, Turkish validity has not been made in this area.
Read the detailed description
SK diseases are the 3 most common disease groups in Turkey, and it has been determined that the rate of discomfort in Turkey is 99%. Although MSK diseases are mostly caused by occupational problems in Turkey, there are clearly information losses and deficiencies in cases such as the risk factors of employers and employees, occupational therapy, lack of insurance payments due to job loss. The study was conducted with 582 office workers. As a result of the study, it was revealed that 55.1% of the participants had back pain and 5% of the participants had back pain, and the rate of women in low back pain was higher.
Keel Start MSK Tool is a tool that provides patients with an appropriate treatment approach, minimizes harm and maximizes treatment benefit. Keele Start MSK Tool msk has been successfully developed for primary care in patients, and it categorizes patients by scoring 9 items and categorizing them into subgroups. This tool is a validated prognostic tool (Keele STarT MSK) with established cut-off points to stratify patients with the five most common musculoskeletal (back, neck, knee, shoulder, multiple painful areas) pain into low, intermediate, and high-risk subgroups. provides 108 patients with low back pain were included in the French version of the Keele STarT Low Back Screening Tool (SBST).
In the UK, which started in 2014, with 1200 patients on MSC pain, stratified; No significant change was achieved as a result of this study, which aims to investigate clinical and cost-effectiveness, as well as to reduce clinician's treatment variability and improve patient outcomes (quality of life, physical function, etc.) since the study has not been completed yet.
In another study, general practitioners screened 3063 patients (1591 interventions, 1472 controls). The EMR template included 1237 eligible patients (513 interventions, 724 controls), while 524 consented to data collection (231 interventions, 293 controls). Although the target of participation was 12 weeks, it took 28 weeks. The target for follow-up was 75% and above and a follow-up rate of over 90% was achieved. As a result of this study, the applicability of the randomized controlled trial design was found to be successful. In addition, the accuracy rate of matched treatment options was also high.
In another UK study, 8 general examinations were randomized (4' stratified care, 4 as regular care) and patients had CNS pain in one of the 5 most common sites. A baseline questionnaire was obtained from the patients, and >90% of these 524 patients were followed up for 8 months. Audio recording or video was taken during the examination. Some patients stated that they wanted to clarify the questions asked, but they could not express themselves well because they had to answer only "yes" or "no" because of this scale. The opinion of the doctors, on the other hand, stated that the result of the Keel Start MSK Tool scale and the treatment approach provided them clinically guiding and different perspectives.
- Conditions
- Musculoskeletal Diseases
- Being tested
- Questionnaire
- Keywords
- musculoskeletal diseases
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
1st Stage Keele Start MSk tool translated into Turkish and its cultural adaptation, 2nd Stage Statistical analysis of reliability and validity of Turkish Keele start msk tool
| Study group | Role | What they receive |
|---|---|---|
| Musculoskeletal Diseas | Experimental | Questionnaires will be asked for the validity of the Turkish version of the Keel Start Tool. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The STarT Back Screening Tool
The STarT Back Screening Tool is a tool designed by Keele University in 2008 to screen prognosis in patients with low back pain in the initial decision-making process.
It consists of 9 items. Subscale scores range from 0 to 5, and patients with 4 or 5 points are classified in the high-risk subgroup. Scores range from 0-9. Patients with a score of 0-3 are classified as a low-risk subgroup and patients with a score of 4-9 are classified as an intermediate-risk subgroup.
Cultural adaptation, internal consistency, test repetition and construct validity of the SBST in Turkey were examined in October 2019.
Measured: First week
Secondary outcomes (3)
The Roland-Morris Questionnaire (RMDQ)
The Roland-Morris Questionnaire (RMDQ) was first developed in 1983. It is a self-administered measure of disability in which higher numbers on a 24-point scale reflect greater disability. Its Turkish validity and reliability were demonstrated in 2001. In the questionnaire consisting of 24 sentences about functional deficiencies, patients are asked to answer each sentence as yes if it fits their situation, and no if it doesn't. Calculating yes answers as "1" and no answers as "0", the total score is between 0-24, with a higher score indicating more disability.
Measured: First week
Short Form-36 (SF-36)
Sf-36 was developed and put into use by Rand Corporation in 1992. The scale consists of 36 items and they provide the measurement of 8 dimensions; physical function (10 items), social function (2 items), role limitations due to physical functions (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/vitality (4 items), pain (2 items) and general perception of health (5 items) .
The scale is evaluated considering the last 4 weeks. In order to create the acute form, a form evaluating the last 1 week was also applied. Evaluation 4th and 5th. Apart from the items, Likert type (three-six-point) is made; Items 4 and 5 are answered as yes/no. Instead of giving only a single total score, the scale gives a total score for each subscale separately. Subscales evaluate health between 0 and 100, and 0 includes poor health, while 100 indicates good health
Measured: First week
The Tampa Kinesiophobia Scale
The Tampa Kinesiophobia Scale was originally developed by R.Miller, S.Kopri, and D.Todd in 1991. The Tampa Kinesiophobia Scale (TSK) is a 17-item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. It was developed to distinguish "non-extreme fear and phobia in patients with chronic musculoskeletal pain". Various studies have found the scale to be a valid and reliable psychometric measure. Initially used to measure fear of movement due to chronic low back pain, TSK was used in different areas including the cervical spine. It is increasingly used for pain related to body parts.TAF is a self-filled questionnaire with a score range of 17 to 68, with higher scores indicating increasing degrees of kinesiophobia.
Measured: First week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Feb 2019
- Primary completion1 May 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Our work will be carried out in two stages. 1st stage Keele start msk tool translated into Turkish and its cultural adaptation, 2nd stage statistical analysis of the reliability and validity of the Turkish Keele start msk tool. Permission was obtained from Keele University, the developer of the scale, before starting the study.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Çırak, Istinye University
- Investigators
- Burcu Pamukçu, Principal investigator, İstinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496621
- Sponsor's protocol ID
- 003
- Status last verified
- Aug 2022
- First submitted
- 7 Feb 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Turkish Version of Keele STarT MSK Tool
- ClinicalTrials.gov ID
- NCT05496621
- Acronym / sponsor ID
- 003
- Conditions
- Musculoskeletal Diseases
- Keywords
- musculoskeletal diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 11 Aug 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 aim of this study is to investigate the usability of the Turkish version of the Keel Start Tool as a valid and reliable method in groups with 5 different types of musculoskeletal pain (knee, neck, shoulder, back, multiple painful areas). When the literature is examined, Turkish validity has not been made in this area.
Detailed description
SK diseases are the 3 most common disease groups in Turkey, and it has been determined that the rate of discomfort in Turkey is 99%. Although MSK diseases are mostly caused by occupational problems in Turkey, there are clearly information losses and deficiencies in cases such as the risk factors of employers and employees, occupational therapy, lack of insurance payments due to job loss. The study was conducted with 582 office workers. As a result of the study, it was revealed that 55.1% of the participants had back pain and 5% of the participants had back pain, and the rate of women in low back pain was higher.
Keel Start MSK Tool is a tool that provides patients with an appropriate treatment approach, minimizes harm and maximizes treatment benefit. Keele Start MSK Tool msk has been successfully developed for primary care in patients, and it categorizes patients by scoring 9 items and categorizing them into subgroups. This tool is a validated prognostic tool (Keele STarT MSK) with established cut-off points to stratify patients with the five most common musculoskeletal (back, neck, knee, shoulder, multiple painful areas) pain into low, intermediate, and high-risk subgroups. provides 108 patients with low back pain were included in the French version of the Keele STarT Low Back Screening Tool (SBST).
In the UK, which started in 2014, with 1200 patients on MSC pain, stratified; No significant change was achieved as a result of this study, which aims to investigate clinical and cost-effectiveness, as well as to reduce clinician's treatment variability and improve patient outcomes (quality of life, physical function, etc.) since the study has not been completed yet.
In another study, general practitioners screened 3063 patients (1591 interventions, 1472 controls). The EMR template included 1237 eligible patients (513 interventions, 724 controls), while 524 consented to data collection (231 interventions, 293 controls). Although the target of participation was 12 weeks, it took 28 weeks. The target for follow-up was 75% and above and a follow-up rate of over 90% was achieved. As a result of this study, the applicability of the randomized controlled trial design was found to be successful. In addition, the accuracy rate of matched treatment options was also high.
In another UK study, 8 general examinations were randomized (4' stratified care, 4 as regular care) and patients had CNS pain in one of the 5 most common sites. A baseline questionnaire was obtained from the patients, and >90% of these 524 patients were followed up for 8 months. Audio recording or video was taken during the examination. Some patients stated that they wanted to clarify the questions asked, but they could not express themselves well because they had to answer only "yes" or "no" because of this scale. The opinion of the doctors, on the other hand, stated that the result of the Keel Start MSK Tool scale and the treatment approach provided them clinically guiding and different perspectives.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Our work will be carried out in two stages. 1st stage Keele start msk tool translated into Turkish and its cultural adaptation, 2nd stage statistical analysis of the reliability and validity of the Turkish Keele start msk tool. Permission was obtained from Keele University, the developer of the scale, before starting the study.
| Arm | Type | Receives |
|---|---|---|
| Musculoskeletal Diseas | Experimental | Other: QuestionnaireQuestionnaires will be asked for the validity of the Turkish version of the Keel Start Tool. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient must be 18 years or older.
- The location of MSC pain must be one of the 5 regions. These 5 regions; knee, shoulder, back, neck, multi-region.
- Volunteering to participate in the study
- The patient's pain must be chronic. chronic pain; If there is general agreement on the definition of pain today, the recognition of pain as a disease is controversial. Depending on their duration, different types of pain are now classified as chronic pain, and the generally accepted definition is "pain that continues after a normal recovery period."
- The patient's Mini mental test score must be 23 and above. The mini mental state examination is scored on a scale of 0-30 with >25 points interpreted as normal cognitive status.
Key exclusion criteria (19 listed)
- Those with serious pathological symptoms
- Joint infection
- Cancer
- Rheumatoid arthritis
- Spondyloarthropathy
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 |
|---|---|---|
| Questionnaire1st Stage Keele Start MSk tool translated into Turkish and its cultural adaptation, 2nd Stage Statistical analysis of reliability and validity of Turkish Keele start msk tool | Other | Musculoskeletal Diseas |
Primary outcome
The STarT Back Screening Tool
Time frame: First week
The STarT Back Screening Tool is a tool designed by Keele University in 2008 to screen prognosis in patients with low back pain in the initial decision-making process. It consists of 9 items. Subscale scores range from 0 to 5, and patients with 4 or 5 points are classified in the high-risk subgroup. Scores range from 0-9. Patients with a score of 0-3 are classified as a low-risk subgroup and patients with a score of 4-9 are classified as an intermediate-risk subgroup. Cultural adaptation, internal consistency, test repetition and construct validity of the SBST in Turkey were examined in October 2019.
3 secondary outcomes
The Roland-Morris Questionnaire (RMDQ)
Time frame: First week
Short Form-36 (SF-36)
Time frame: First week
The Tampa Kinesiophobia Scale
Time frame: First week
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 11 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Burcu Pamukçu principal investigator
İstinye University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Musculoskeletal Diseases, run by Istinye University 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 5 inclusion and 19 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 11 Aug 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?
The STarT Back Screening Tool (time frame: First week). 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 11 Aug 2022.