Psychometric Properties of Pain Scale in Low Back Pain

NCT06113185 | Recruiting

• 1 other identifier: 2023-15/518
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

Psychometric Properties; Pain Behavior Scale

Outcome Measures

Primary Outcomes (3)

• 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 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.

  At the beginning of the study and up to 1 weeks

• 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

• 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 Outcomes (2)

• Oswestry Disability Index

  At the beginning of the study

• Fear-Avoidance Beliefs Questionnaire

  At the beginning of the study

Interventions

survey OTHER

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.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients on the waiting list with a diagnosis of chronic nonspecific low back pain who applied to the Physical Therapy and Rehabilitation Outpatient Clinic of Acıbadem Health Group hospitals with complaints of low back pain will participate in the study.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acıbadem Health Group

Istanbul, None Selected, 34752, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Elif E Safran, asst. prof.

  Acibadem Healthcare Group

  PRINCIPAL INVESTIGATOR

• Irmak Çavuşoğlu, asst. prof.

  Acibadem Healthcare Group

  STUDY CHAIR

• Nuray Alaca, assoc. prof.

  Acibadem Healthcare Group

  STUDY DIRECTOR

Central Study Contacts

Elif E Safran, asst. prof.

CONTACT

500 4047; elif.bayraktar@acibadem.edu.tr

Nuray Alaca, assoc. prof.

CONTACT

500 4181; nuray.alaca@acibadem.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 2, 2023
• Study Start: February 21, 2024
• Primary Completion: November 1, 2024
• Study Completion: January 1, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

TU (1)