Relationship Between Kinesiophobia, Physical Activity and Disability Level and Pain Management in Patients With CLBP

November 8, 2023 updated by: Ayse Unal, Alanya Alaaddin Keykubat University

The Relationship Between Kinesiophobia, Physical Activity and Disability Level and Pain Management in Patients With Chronic Low Back Pain in Genders

The aim of this study was to examine the relationship between pain management, kinesiophobia, physical activity and disability level in patients with chronic low back pain (CLBP) in different genders. Eighty-two patients with CLBP (42 females, 42 males) between the ages of 20-60 participated in the study. Pain management strategies were determined by Pain Coping Questionnaire (PCQ). Tampa Scale for Kinesiophobia for perception of kinesiophobia, Oswestry Disability Index for disability due to pain and International Physical Activity Questionnaire-Short Form (IPAQ-SF) for the physical activity level were used.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Contacts and Locations

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

Study Locations

  • Turkey
      • Denizli, Turkey, 20160
        • Pamukkale University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

One hundred twenty-six subjects were invited to participate in the study. The study was completed with the participation of 84 subjects, 42 women and 42 men.

Description

Inclusion Criteria:

  • Individuals who are between 20 and 60 years old,
  • Experienced low back pain lasting longer than 3 months, and had no problems with reading, writing, and comprehension were included in the study.

Exclusion Criteria:

  • Individuals who underwent surgery for low back pain,
  • Had any diagnosed spinal problem,
  • Who were pregnant,
  • And who had communication problems were not included in the study.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Female
Forty one females with CLBP between the ages of 20-60 participated in the study. Pain management strategies were determined by Pain Coping Questionnaire (PCQ). Tampa Scale for Kinesiophobia for perception of kinesiophobia, Oswestry Disability Index for disability due to pain and International Physical Activity Questionnaire-Short Form (IPAQ-SF) for the physical activity level were used.
Other: Pain management
Investigation of relationship between kinesiophobia, physical activity and disability level and pain management in patients with CLBP
Male
Forty one males with CLBP between the ages of 20-60 participated in the study. Pain management strategies were determined by Pain Coping Questionnaire (PCQ). Tampa Scale for Kinesiophobia for perception of kinesiophobia, Oswestry Disability Index for disability due to pain and International Physical Activity Questionnaire-Short Form (IPAQ-SF) for the physical activity level were used.
Other: Pain management
Investigation of relationship between kinesiophobia, physical activity and disability level and pain management in patients with CLBP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Coping Questionnaire (PCQ)
Time Frame: From 25 December 2019 to 10 November 2021
The scale assesses how chronic pain patients cope with organic or psychogenic pain. The scale consists of four subdimensions that are self-coping, helplessness, conscious cognitive interventions, and seeking medical help, and 29 items. The self-report scale consists of a 4-point Likert scale (0: never, 3: often).
From 25 December 2019 to 10 November 2021

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
Time Frame: From 25 December 2019 to 10 November 2021
Subjects were asked to mark the severity of pain on a 10-cm line. The lowest point indicated the least severity of pain, and the highest point indicated the maximum pain value.
From 25 December 2019 to 10 November 2021
Oswestry Disability Index (ODI)
Time Frame: From 25 December 2019 to 10 November 2021
It consists of 10 items measuring the severity of pain, personal care, lifting, walking, sitting, standing, social life, sleeping, traveling, and degree of pain. Each item is scored between 0-5. The higher the total score, the higher the degree of disability. The maximum score is 50 points.
From 25 December 2019 to 10 November 2021
Tampa Scale of Kinesiophobia (TSK)
Time Frame: From 25 December 2019 to 10 November 2021
The scale is scored between 17 and 68 using a 4-point Likert type scale scoring system. A high score on the scale indicates a high level of kinesiophobia.
From 25 December 2019 to 10 November 2021
International Physical Activity Questionnaire-Short Form (IPAQ -SF)
Time Frame: From 25 December 2019 to 10 November 2021
The questionnaire provides information on time spent walking, moderate to vigorous activity, and vigorous activity. Time spent sitting is included as a separate question. The total score calculation includes the sum of time (minutes) and frequency (days) of walking, moderate activity, and vigorous activity.
From 25 December 2019 to 10 November 2021

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alanya Alaaddin Keykubat University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ayşe Ünal, Assoc. Prof, Alanya Alaaddin Keykubat 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 60116787-020/92289

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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