Clinical trial NCT06694493: Factors Associated With Quality of Life in Chronic Low Back Pain
Official title: Factors Associated With Quality of Life in Chronic Low Back Pain: A Structural Equation Modelling Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Low-back Pain (cLBP)
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People between the ages of 18-65, who volunteered to participate in the study, and who had low back pain for more than 3 months will be included in the study.

Brief summary: The aim of this study was to identify and validate the factors that may affect quality of life in patients with chronic low back pain.

Detailed description: Participants between the ages of 18-65, who are willing to participate in the study and have low back pain for more than 3 months will be included in the study. The necessary demographic information will be obtained with a data form. For the evaluation; Visual Analogue Scale (VAS), Tampa Kinesiophobia Scale, Fear-Avoidance Beliefs Questionnaire, Roland-Morris Disability Questionnaire, Beck Depression Scale, Self-Efficacy for Managing Chronic Disease 6-Item Scale, Coping Strategies Inventory Short Form (CSI-SF), Pain Catastrophising Scale, Pittsburgh Sleep Quality Index, Short Form - 36 (Quality of Life Questionnaire) will be used. The data obtained in the study will be entered into SPSS 17 package programme (Greasley, 2007). Minimum-maximum values, arithmetic mean and standard deviation will be used to evaluate numerical data, and frequency distributions and percentages will be used to summarise categorical data. The data of the study will be analysed using Analysis of Moment Structures (AMOS) statistical package programmes. In all analyses, p\<0.05 will be considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study
* Having low back pain for more than 3 months
* Being between the ages of 18-65

Exclusion Criteria:

* History of surgery in the spinal region
* Rheumatoid arthritis
* Tumour
* Autoimmune disease
* Neurological disease
* Psychiatric or cognitive impairment

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 1 minute
measure: Tampa Kinesiophobia Scale
timeFrame: 5 minute
measure: Fear-Avoidance Beliefs Questionnaire
timeFrame: 5 minute
measure: Roland-Morris Disability Questionnaire
timeFrame: 5 minute
measure: Beck Depression Scale
timeFrame: 5 minute
measure: Self-Efficacy for Managing Chronic Disease 6-Item Scale
timeFrame: 3 minute
measure: Coping Strategies Inventory Short Form (CSI-SF)
timeFrame: 5 minute
measure: Pain Catastrophising Scale
timeFrame: 5 minute
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 5 minute
measure: Short Form - 36 Quality of Life Questionnaire (SF-36)
timeFrame: 7 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Science University
Study officials:
affiliation: Kutahya Health Science University
name: Emrah Afsar, Phd
role: PRINCIPAL_INVESTIGATOR
References: