- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06125496
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
Study Type
Observational
Enrollment (Actual)
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
-
-
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Denizli, Turkey, 20160
- Pamukkale University
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-
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
- 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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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).
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From 25 December 2019 to 10 November 2021
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Secondary Outcome Measures
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.
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From 25 December 2019 to 10 November 2021
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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.
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From 25 December 2019 to 10 November 2021
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Tampa Scale of Kinesiophobia (TSK)
Time Frame: From 25 December 2019 to 10 November 2021
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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.
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From 25 December 2019 to 10 November 2021
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International Physical Activity Questionnaire-Short Form (IPAQ -SF)
Time Frame: From 25 December 2019 to 10 November 2021
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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.
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From 25 December 2019 to 10 November 2021
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- 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)
December 25, 2019
Primary Completion (Actual)
November 20, 2021
Study Completion (Actual)
December 28, 2021
Study Registration Dates
First Submitted
November 3, 2023
First Submitted That Met QC Criteria
November 8, 2023
First Posted (Estimated)
November 9, 2023
Study Record Updates
Last Update Posted (Estimated)
November 9, 2023
Last Update Submitted That Met QC Criteria
November 8, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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