Low Back PainNCT06125496
Relationship Between Kinesiophobia, Physical Activity and Disability Level and Pain Management in Patients With CLBP
An observational study of Low Back Pain, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Pain management
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2019to 28 Dec 2021
- 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 60 years
- All sexes
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Low Back Pain
- Being tested
- Pain management
- Keywords
- Pain management, Kinesiophobia, Physical activity, Disability
- Medical subject headings
- Low Back Pain, Agnosia, Kinesiophobia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain managementOther
Investigation of relationship between kinesiophobia, physical activity and disability level and pain management in patients with CLBP
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pain management | |
| 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. Receives: Other: Pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Coping Questionnaire (PCQ)
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).
Measured: From 25 December 2019 to 10 November 2021
Secondary outcomes (4)
Visual Analogue Scale (VAS)
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.
Measured: From 25 December 2019 to 10 November 2021
Oswestry Disability Index (ODI)
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.
Measured: From 25 December 2019 to 10 November 2021
Tampa Scale of Kinesiophobia (TSK)
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.
Measured: From 25 December 2019 to 10 November 2021
International Physical Activity Questionnaire-Short Form (IPAQ -SF)
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.
Measured: From 25 December 2019 to 10 November 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start25 Dec 2019
- Primary completion20 Nov 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Other
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Unal, Alanya Alaaddin Keykubat University
- Investigators
- Ayşe Ünal, Assoc. Prof, Principal investigator, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125496
- Sponsor's protocol ID
- 60116787-020/92289
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- 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 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Kinesiophobia, Physical Activity and Disability Level and Pain Management in Patients With Chronic Low Back Pain in Genders
- ClinicalTrials.gov ID
- NCT06125496
- Acronym / sponsor ID
- 60116787-020/92289
- Conditions
- Low Back Pain
- Keywords
- Pain management, Kinesiophobia, Physical activity, Disability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 25 Dec 2019 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 9 Nov 2023 (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 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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female | – | Other: Pain managementForty 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. |
| Male | – | Other: Pain managementForty 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Pain managementInvestigation of relationship between kinesiophobia, physical activity and disability level and pain management in patients with CLBP | Other | Female, Male |
Primary outcome
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).
4 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: From 25 December 2019 to 10 November 2021
Oswestry Disability Index (ODI)
Time frame: From 25 December 2019 to 10 November 2021
Tampa Scale of Kinesiophobia (TSK)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- 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.
Ayşe Ünal, Assoc. Prof principal investigator
Alanya Alaaddin Keykubat 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 Low Back Pain, run by Alanya Alaaddin Keykubat 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 9 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Coping Questionnaire (PCQ) (time frame: From 25 December 2019 to 10 November 2021). 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 9 Nov 2023.