Musculoskeletal PainNCT05320679
Development of Pain Related Avoidance of Movement Questionnaire
An observational study of Musculoskeletal Pain and Low Back Pain, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
In recent studies, it has been shown that people may have avoidance of movement due to pain. However, there is no scale that evaluates avoidance of movement due to pain in musculoskeletal problems. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Musculoskeletal Pain, Low Back Pain, Back Pain
- What is being tested?
- Implementation of Questionnaire
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Apr 2022to 30 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants are going to be patients who have musculoskeletal pain problem.
Who may be able to join
- Having agreed to fill out the questionnaire
- Having pain caused by problems related to the musculoskeletal system
- Not having any disability in performing activities of daily living
Who cannot join
- Individuals who are not allowed to move due to pain
- If they have undergone surgery, individuals who have inconveniences in moving due to surgery
- Individuals who have cognitive problems in completing the questionnaire
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hasan Kalyoncu University
Gaziantep, 27100
Yavuz Yakut, Prof. Dr., +905324181001, yyakut@yahoo.com
About this study
Official title: Development and Implementation of Pain Related Avoidance of Movement
In recent studies, it has been shown that people may have avoidance of movement due to pain. However, there is no scale that evaluates avoidance of movement due to pain in musculoskeletal problems. The aim of this study is to develop a scale to measure how much pain-related movement and activity is avoided in individuals with musculoskeletal pain, and to examine the results of its clinical application.
Read the detailed description
Approaches and methods to be applied in the research;
- Demographic information (age, gender, weight, height, pain location, pain duration and diagnose) form will be recorded.
- Creation of questionnaire items
- Reviewing of items/questions
- Patients who accept to fill out the questionnaire and who has complain of musculoskeletal pain will be asked to answer the questions.
- Editing the scale according to the answers
- Reliability and validity studies of the questionnaire
- Investigation of the results of applying the scale with clinical follow-up
To compare results of Pain-Related Avoidance of Movement Questionnaire following common used questionnaires are going to be used;
- Visual Analogue Scale (VAS)
- Tampa Kinesiophobia Scale
- Oswestry Low Back Pain and Disability Index-2.0
SPSS version 23 (SPSS Inc, Armonk, NY) program will be used in the analysis of the data.
- Conditions
- Musculoskeletal Pain, Low Back Pain, Back Pain
- Being tested
- Implementation of Questionnaire
- Keywords
- Musculoskeletal pain, Kinesiophobia, Questionnaire
- Medical subject headings
- Musculoskeletal Pain, Low Back Pain, Back Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of QuestionnaireOther
Compartment of results of questionnaires which already been used in literature and results of developing Pain Related Avoidance of Movement Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Patients who have musculoskeletal pain Receives: Other: Implementation of Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total points of Pain Related Avoidance of Movement Questionnaire
Pain related avoidance of movement score is going to be assess by Pain Related Avoidance of Movement Questionnaire to determine change from baseline and, to examine correlation of other questionnaires.
Measured: 1 week
Secondary outcomes (3)
Change from baseline score in pain score
Pain score is going to be assess by VAS to determine change from baseline. Normal range of VAS score is between 0 point to 10 points. Higher score means worse pain level.
Measured: 1 week
Change from baseline score in kinesiophobia score
Kinesiophobia score is going to be assess by Tampa Kinesiophobia Scale to determine change from baseline. The normal range of kinesiophobia score is between 17 points to 68 points. Higher score means worse kinesiophobia level.
Measured: 1 week
Change from baseline in disability score
Disability score is going to be assess by Oswestry Disability Index to determine the change from baseline. The normal range of percentage is between 0 to 100. Higher percentage means worse disability level.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start2 Apr 2022
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yavuz Yakut, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320679
- Sponsor's protocol ID
- 2020/021
- Status last verified
- Apr 2022
- First submitted
- 2 Apr 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of Pain Related Avoidance of Movement
- ClinicalTrials.gov ID
- NCT05320679
- Acronym / sponsor ID
- 2020/021
- Conditions
- Musculoskeletal Pain, Low Back Pain, Back Pain
- Keywords
- Musculoskeletal pain, Kinesiophobia, Questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 2 Apr 2022 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 11 Apr 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.
In recent studies, it has been shown that people may have avoidance of movement due to pain. However, there is no scale that evaluates avoidance of movement due to pain in musculoskeletal problems. The aim of this study is to develop a scale to measure how much pain-related movement and activity is avoided in individuals with musculoskeletal pain, and to examine the results of its clinical application.
Detailed description
Approaches and methods to be applied in the research;
- Demographic information (age, gender, weight, height, pain location, pain duration and diagnose) form will be recorded.
- Creation of questionnaire items
- Reviewing of items/questions
- Patients who accept to fill out the questionnaire and who has complain of musculoskeletal pain will be asked to answer the questions.
- Editing the scale according to the answers
- Reliability and validity studies of the questionnaire
- Investigation of the results of applying the scale with clinical follow-up
To compare results of Pain-Related Avoidance of Movement Questionnaire following common used questionnaires are going to be used;
- Visual Analogue Scale (VAS)
- Tampa Kinesiophobia Scale
- Oswestry Low Back Pain and Disability Index-2.0
SPSS version 23 (SPSS Inc, Armonk, NY) program will be used in the analysis of the data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Implementation of QuestionnairePatients who have musculoskeletal pain |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants are going to be patients who have musculoskeletal pain problem.
Key inclusion criteria (3 listed)
- Having agreed to fill out the questionnaire
- Having pain caused by problems related to the musculoskeletal system
- Not having any disability in performing activities of daily living
Key exclusion criteria (3 listed)
- Individuals who are not allowed to move due to pain
- If they have undergone surgery, individuals who have inconveniences in moving due to surgery
- Individuals who have cognitive problems in completing the questionnaire
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 |
|---|---|---|
| Implementation of QuestionnaireCompartment of results of questionnaires which already been used in literature and results of developing Pain Related Avoidance of Movement Questionnaire | Other | Study Group |
Primary outcome
Total points of Pain Related Avoidance of Movement Questionnaire
Time frame: 1 week
Pain related avoidance of movement score is going to be assess by Pain Related Avoidance of Movement Questionnaire to determine change from baseline and, to examine correlation of other questionnaires.
3 secondary outcomes
Change from baseline score in pain score
Time frame: 1 week
Change from baseline score in kinesiophobia score
Time frame: 1 week
Change from baseline in disability score
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
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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.
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 Musculoskeletal Pain and Low Back Pain, run by Hasan Kalyoncu 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 3 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: status not confirmed, as of the sponsor's last update on 15 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total points of Pain Related Avoidance of Movement Questionnaire (time frame: 1 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 15 Apr 2022.