## Protocol Section
### Identification Module
**NCT ID:** NCT05320679

**Brief Title:** Development of Pain Related Avoidance of Movement Questionnaire

**Official Title:** Development and Implementation of Pain Related Avoidance of Movement

#### Organization Study ID Info
**ID:** 2020/021
#### Organization
**Class:** OTHER
**Full Name:** Hasan Kalyoncu University
### Status Module
#### Completion Date
**Date:** 2022-12-30

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2022-04-15

**Type:** ACTUAL

**Last Update Submit Date:** 2022-04-08

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-08-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-04-02

**Type:** ACTUAL

**Status Verified Date:** 2022-04

#### Study First Post Date
**Date:** 2022-04-11
**Type:** ACTUAL
**Study First Submit Date:** 2022-04-02
**Study First Submit QC Date:** 2022-04-02
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hasan Kalyoncu University

#### Responsible Party

**Investigator Affiliation:** Hasan Kalyoncu University

**Investigator Full Name:** Yavuz Yakut

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**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 Module

**Conditions:**

- Musculoskeletal Pain

- Low Back Pain

- Back Pain

**Keywords:**

- Musculoskeletal pain

- Kinesiophobia

- Questionnaire

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 400

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients who have musculoskeletal pain

**Intervention Names:**

- Other: Implementation of Questionnaire

**Label:** Study Group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Study Group

**Description:** Compartment of results of questionnaires which already been used in literature and results of developing Pain Related Avoidance of Movement Questionnaire

**Name:** Implementation of Questionnaire

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Total points of Pain Related Avoidance of Movement Questionnaire

**Time Frame:** 1 week

#### Secondary Outcomes

**Description:** 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.

**Measure:** Change from baseline score in pain score

**Time Frame:** 1 week

**Description:** 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.

**Measure:** Change from baseline score in kinesiophobia score

**Time Frame:** 1 week

**Description:** 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.

**Measure:** Change from baseline in disability score

**Time Frame:** 1 week

### Eligibility Module

**Eligibility Criteria:** 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

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Participants are going to be patients who have musculoskeletal pain problem.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Gaziantep

**Contacts:**

***Contact 1:***

- **Email:** yyakut@yahoo.com

- **Name:** Yavuz Yakut, Prof. Dr.

- **Phone:** +905324181001

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Hasan Kalyoncu University

**Status:** RECRUITING

**Zip:** 27100

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M4714

- Name: Back Pain

- Relevance: HIGH

- As Found: Back Pain

- ID: M19433

- Name: Low Back Pain

- Relevance: HIGH

- As Found: Low Back Pain

- ID: M2922

- Name: Kinesiophobia

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M29444

- Name: Musculoskeletal Pain

- Relevance: HIGH

- As Found: Musculoskeletal Pain

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000059352

- Term: Musculoskeletal Pain

- ID: D000001416

- Term: Back Pain

- ID: D000017116

- Term: Low Back Pain

### Misc Info Module

- Version Holder: 2024-05-24
