Back Pain Lower Back ChronicNCT05232747
Behavioral and Emotional Factors Associated With Pain Severity
An observational study of Back Pain Lower Back Chronic, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain Lower Back Chronic
- What is being tested?
- Diagnostic Test
- How many people
- 123 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jan 2022to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with low back pain
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mehmet Duray
Isparta, 32200
Mehmet Duray, 02462113268, mehmetduray@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Back Pain Lower Back Chronic
- Being tested
- Diagnostic Test
- Keywords
- Back pain, Pain Beliefs, Pain Coping, Behavioral, Emotional
- Medical subject headings
- Back Pain, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic TestDiagnostic test
Diagnostic Test
| Study group | Role | What they receive |
|---|---|---|
| Study | Participants' pain level and pain-related behaviors will be questioned. Receives: Diagnostic Test: Diagnostic Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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').
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start19 Jan 2022
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain Lower Back ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Duray, Suleyman Demirel University
- Investigators
- Mehmet Duray, Principal investigator, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232747
- Sponsor's protocol ID
- 72867572-050.01.04-196254
- Status last verified
- Feb 2022
- First submitted
- 28 Jan 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Behavioral and Emotional Factors Associated With Pain Severity in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05232747
- Acronym / sponsor ID
- 72867572-050.01.04-196254
- Conditions
- Back Pain Lower Back Chronic
- Keywords
- Back pain, Pain Beliefs, Pain Coping, Behavioral, Emotional
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study | – | Diagnostic Test: Diagnostic TestParticipants' pain level and pain-related behaviors will be questioned. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with low back pain
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic TestDiagnostic Test | Diagnostic test | Study |
Primary outcome
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".
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').
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Duray principal investigator
Suleyman Demirel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Back Pain Lower Back Chronic, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Duray (00902462113328, mehmetduray@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visuel Analog Scale (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.