Development of Pain Related Avoidance of Movement Questionnaire

Low Back Pain Clinical Trial

Official title:

Development and Implementation of Pain Related Avoidance of Movement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05320679
• Other study ID #: 2020/021
• Status: Recruiting
• Start date: April 2, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: April 2022
• Source: Hasan Kalyoncu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Musculoskeletal Pain

Intervention

Other:
• Implementation of Questionnaire
Compartment of results of questionnaires which already been used in literature and results of developing Pain Related Avoidance of Movement Questionnaire

Locations

Country	Name	City	State
Turkey	Hasan Kalyoncu University	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 week
Secondary	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.	1 week
Secondary	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.	1 week
Secondary	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.	1 week