Psychometric Properties of Pain Scale in Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

Turkish Psychometric Properties of Pain Behavior Scale in Patients With Chronic Low Back Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06113185
• Other study ID #: 2023-15/518
• Status: Not yet recruiting
• Start date: January 2024
• Est. completion date: May 2024

Study information

• Verified date: December 2023
• Source: Acibadem University
• Contact: Elif E Safran, asst. prof.
• Phone: 500 4047
• Email: elif.bayraktar[@]acibadem.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• survey
Demographic and clinical information of the participants will be recorded using a standardized form. The cognitive status of the patient will be evaluated according to the answers to the questions asked to the patient during the questioning of demographic data and reading and signing the consent form. The participants will be asked to complete a series of questionnaires to assess pain intensity and characteristics, pain-related functional disability, and pain-related fear-avoidance behavior. To record the presence and severity of pain behaviors exhibited during physical performance tests, patients will be asked to complete 5 functional tests (repetitive trunk flexion, repetitive sit-to-stand, timed get-up-and-go test, reach with load, 50-step walk test) and observers will simultaneously complete the Pain Behavior Scale. Each participant will be asked to attend two testing sessions separated by one week and occurring before the start of treatment.

Locations

Country	Name	City	State
Turkey	Acibadem Health Group	Istanbul	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Behavior Scale	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; The presence or absence of each behavior; 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.	At the beginning of the study and up to 1 weeks
Primary	Visual Analog Scale	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.	At the beginning of the study
Primary	McGill Pain Questionnaire-Short Form	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.	At the beginning of the study
Secondary	Oswestry Disability Index	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.	At the beginning of the study
Secondary	Fear-Avoidance Beliefs Questionnaire	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.	At the beginning of the study