Behavioral and Emotional Factors Associated With Pain Severity

February 9, 2022 updated by: Mehmet Duray, Suleyman Demirel University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

123

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with low back pain

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study
Participants' pain level and pain-related behaviors will be questioned.
Diagnostic test: Diagnostic Test
Diagnostic Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visuel Analog Scale
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suleyman Demirel University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2022

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

January 28, 2022

First Submitted That Met QC Criteria

February 9, 2022

First Posted (Actual)

February 10, 2022

Study Record Updates

Last Update Posted (Actual)

February 10, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 72867572-050.01.04-196254

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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