Behavioral and Emotional Factors Associated With Pain Severity

NCT05232747 | Unknown

• 1 other identifier: 72867572-050.01.04-196254
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

The planned research will address the behavioral and emotional factors associated with low back pain rather than a structural and biological cause. It will be determined to what extent the results obtained according to the ICF model are effective on the participation of patients with low back pain in daily activities, and it will become clear whether patients with low back pain should be approached only mechanically in the rehabilitation programs.

Conditions

Back Pain Lower Back Chronic

Keywords

Back pain; Pain Beliefs; Pain Coping; Behavioral; Emotional

Outcome Measures

Primary Outcomes (4)

• Visuel Analog Scale

  Visual Analogue Scale will be used to evaluate the severity of low back pain. The back pain they feel during activity and rest will be questioned separately from the participants. For this assessment, patients will be asked to mark their pain intensity on a 10-centimeter line. Pain intensity will be determined by measuring the distance of the marked point to the "0" point with a tape measure. Scoring is done on a scale of 0-10 and "0 means no pain"- "10 means the most severe pain imaginable".

  3 months

• The Pain Beliefs Questionnaire

  It was developed by Edwards et al. in 1992 to evaluate beliefs about the cause and treatment of pain. In our country, the validity and reliability study of the scale was carried out by Berk in 2006 and it was adapted to Turkish. There are 12 items in this scale covering pain beliefs. Accordingly, the scale consisted of two test areas: Organic Beliefs consisting of 8 items and Psychological Beliefs consisting of 4 items. The Organic Belief test reflects that the pain is largely of organic origin. (For example, 'pain is caused by damage to tissues in the body' and 'pain experience is a sign of something wrong with the body.) Psychological Belief test shows that the experience of pain is under the influence of psychological factors. (For example, 'worrying makes the pain worse.' 'thinking about the pain makes the pain worse').

  3 months

• Pain Coping Questionnaire

  It was developed by Kleinke in 1992 to reveal pain-specific affect and behavior patterns. The scale assesses the way chronic pain patients cope with organic or psychogenic pain. The validity and reliability study of the scale was performed by Karaca et al. in 1996 and adapted to Turkish. The scale consists of 4 subtests. These; Self-Coping, Helplessness, Conscious Cognitive Interventions, Medical Remedy Seeking subtests.

  3 months

• Fear-Avoidance Beliefs Questionnaire

  It has 16 questions and two subscales: physical activity and work. The physical activity section consists of 5 questions and the labor section consists of 11 questions. The questionnaire is a 7-point Likert type scale. In the answers given to the questionnaire, 0 points are given to the statement of "I don't agree at all" and 6 points to the statement of "I totally agree". Both subscale scores can be used independently. There are 16 questions in the original of the CCSI developed by Waddell. It is accepted that there is a decrease in fear-avoidance behavior within the department as the total score approaches 0 in the evaluation, and an increase in fear-avoidance behavior as it approaches the maximum score.

  3 months

Study Arms (1)

Study

Participants' pain level and pain-related behaviors will be questioned.

Diagnostic Test: Diagnostic Test

Interventions

Diagnostic Test DIAGNOSTIC_TEST

Diagnostic Test

Study

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with low back pain

You may qualify if:

• Being between 20-55 years old
• Having a history of chronic low back pain for at least 3 months
• Having a low back pain level of 1 or higher according to the Visual Analog Scale

You may not qualify if:

• Having had any surgery on the lumbar region
• Having a history of lower extremity surgery
• Having acute low back pain
• Having a neurological disease
• Having sensory loss
• Presence of a rheumatological disease that may cause low back pain
• Having a herniated disc pressing on the sacral nerves
• being pregnant

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Mehmet Duray

Isparta, 32200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Back Pain; Behavior

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mehmet Duray

  Suleyman Demirel University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet Duray

CONTACT

00902462113328; mehmetduray@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 10, 2022
• Study Start: January 19, 2022
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)