Psychometric Properties of Pain Scale in Low Back Pain

Recruiting

• Conditions: Chronic Low Back Pain

• Registration Number: NCT06113185
• Lead Sponsor: Acibadem University

Brief Summary

The aim of this study was to examine the Turkish validity of the Pain Behavior Scale in a population with chronic non-specific low back pain and to examine both intra-rater and inter-rater reliability. In addition, since this test package includes a series of functional activities, it is aimed to assess pain behaviors during functional movement in this population and to verify the test-retest reliability of physical performance tests.

Detailed Description

To assess the extent to which individuals with chronic low back pain are affected during functional task performance, the presence or absence of pain behaviors and the severity of observed pain behavior should be considered. The Pain Behavior Scale has potential clinical application both for assessing pain behaviors during regular physical examination and for measuring the presence and severity of pain behaviors during functional movement. There is no similar assessment tool that offers all of these simultaneously. Therefore, this study aimed to examine the Turkish validity of the Pain Behavior Scale in a population with chronic non-specific low back pain and to test its intra- and inter-rater reliability.

Study Timeline

• Study First Submitted: 2023-10-24
• Study First Submitted QC: 2023-10-31
• Study First Posted: 2023-11-02
• Study Start: 2024-02-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2024-11
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Non-specific low back pain for more than three months
• Being between the ages of 18-55
• Adequate cognitive functions (reading, writing, recall, orientation, language)

Exclusion Criteria

• Presence of a serious underlying pathology (e.g. cancer, infection or cauda equina syndrome)
• Presence of spinal stenosis
• Presence of signs of radiculopathy (presence of neural symptoms such as pain radiating to the lower extremities, weakness, numbness and tingling sensation)
• Presence of fracture or surgical history in the relevant area
• Presence of rheumatic disease history
• Presence of pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Behavior Scale	At the beginning of the study and up to 1 weeks	The Pain Behavior Scale was developed to record the presence and severity of pain behaviors exhibited during physical performance tests. Specific pain behaviors assessed are sighing, breath holding, grimacing, guarding, rubbing and antalgic gait. The Pain Behavior Scale consists of a 4-point scale ranging from "None" (no observed behavior) to "Severe" (marked pain behavior).; Two measures are obtained from the scale; 1. The presence or absence of each behavior; 2. Total score for the severity of general pain behaviors. The scale will be used during the implementation of physical performance tests lasting 10-15 minutes.
Visual Analog Scale	At the beginning of the study	The Visual Analog Scale, which is used to record the intensity of pain, consists of a single 10 cm line; the left end is described as "No pain" and the right end is described as "The most severe pain experienced in life". Patients will be asked to mark the severity of their current pain on the 10 cm line. During the calculation, the marked point will be measured in cm. The higher the score, the more severe the pain.
McGill Pain Questionnaire-Short Form	At the beginning of the study	The McGill Pain Questionnaire Short Form consists of three parts. In the first part, patients are asked to describe their pain with 15 descriptive words (11 sensory and 4 affective). In the second part, the severity of the patient's pain is evaluated. In the third part, patients are asked to mark their current pain intensity on a visual comparison scale.

Secondary Outcome Measures

Name	Time	Method
Fear-Avoidance Beliefs Questionnaire	At the beginning of the study	The Fear-Avoidance Beliefs Questionnaire consists of two subscales, physical activity and work, and a total of 16 questions (5 physical activity sections and 11 work sections). The questionnaire is a 7-point Likert-type scale. In the answers to the questionnaire, 0 points are given for strongly disagree and 6 points are given for strongly agree. Both subscale scores can be used independently.
Oswestry Disability Index	At the beginning of the study	The Oswestry Disability Index consists of 10 questions questioning the severity of pain, self-care, lifting-carrying, walking, sitting, standing, sleeping, the degree of change in pain, travel and social life and the questions are scored between 0-5. The total score is calculated as a percentage and the higher the total score, the higher the level of functional disability.

Trial Locations

Locations (1)

Acıbadem Health Group; 🇹🇷 Istanbul, None Selected, Turkey