Behavioral and Emotional Factors Associated With Pain Severity

Back Pain Lower Back Chronic Clinical Trial

Official title:

Determination of Behavioral and Emotional Factors Associated With Pain Severity in Patients With Chronic Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05232747
• Other study ID #: 72867572-050.01.04-196254
• Status: Recruiting
• Start date: January 19, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: February 2022
• Source: Suleyman Demirel University
• Contact: Mehmet Duray
• Phone: 00902462113328
• Email: mehmetduray[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Chronic low back pain is among the most important health and economic problems of today. In particular, the success of chronic low back pain treatment with current approaches based on the biomedical care model, which is thought to be synonymous with pain and tissue damage, is limited. It has been demonstrated that tissue damage is not a prerequisite for the development of chronic low back pain. Several studies have shown a strong association between chronic low back pain and psychological factors such as anxiety, fear avoidance, distress/depressed mood, anger, poor coping strategies, and low pain self-efficacy. Despite all this important information and evidence, there is a lack of an overview of the behavioral and emotional factors associated with pain severity, as studies mostly focus on a few major factors. However, the strong interaction between behavioral and emotional factors leads to confusion. The psychological factors mentioned above are open to discussion, and people with chronic low back pain may experience increased pain severity as a result of emotional processing inadequacy. Baker et al identified five factors for emotional processing deficits related to emotion suppression, unprocessed emotion symptoms, unregulated emotion, avoidance, and poor emotional experience. It is hypothesized that the stated emotional processing deficits have a potential role in the increase in pain severity and development of pain in individuals with chronic low back pain. Therefore, depending on the severity of emotional processing openness, the person may feel pain more than it actually is, exhibit more fear avoidance behavior, and develop negative coping strategies with pain. More recently, Baker et al. argued that the sensation of pain lies at the interface between physical and psychological processes, and therefore, impaired emotional processing may be associated with both psychological factors and physical conditions such as chronic low back pain. However, it is currently unknown whether patients with chronic low back pain process pain sensation differently from asymptomatic individuals. Therefore, behavioral and emotional factors related to pain severity have not been clearly revealed. The aim of this study is to determine the behavioral and emotional factors associated with pain severity in patients with chronic low back pain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 123
• Est. completion date: June 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Back Pain
• Back Pain Lower Back Chronic
• Pain

Intervention

Diagnostic Test:
• Diagnostic Test
Diagnostic Test

Locations

Country	Name	City	State
Turkey	Mehmet Duray	Isparta

Sponsors (1)

Lead Sponsor	Collaborator
Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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