- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05320679
Development of Pain Related Avoidance of Movement Questionnaire
April 8, 2022 updated by: Yavuz Yakut, Hasan Kalyoncu University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Gaziantep, Turkey, 27100
- Recruiting
- Hasan Kalyoncu University
-
Contact:
- Yavuz Yakut, Prof. Dr.
- Phone Number: +905324181001
- Email: yyakut@yahoo.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants are going to be patients who have musculoskeletal pain problem.
Description
Inclusion Criteria;
- 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
Exclusion Criteria;
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study Group
Patients who have musculoskeletal pain
|
Compartment of results of questionnaires which already been used in literature and results of developing Pain Related Avoidance of Movement Questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline score in pain score
Time Frame: 1 week
|
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.
|
1 week
|
Change from baseline score in kinesiophobia score
Time Frame: 1 week
|
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.
|
1 week
|
Change from baseline in disability score
Time Frame: 1 week
|
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.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 2, 2022
Primary Completion (Anticipated)
August 30, 2022
Study Completion (Anticipated)
December 30, 2022
Study Registration Dates
First Submitted
April 2, 2022
First Submitted That Met QC Criteria
April 2, 2022
First Posted (Actual)
April 11, 2022
Study Record Updates
Last Update Posted (Actual)
April 15, 2022
Last Update Submitted That Met QC Criteria
April 8, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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