Neck PainNCT06194812
Minimal Clinical Important Change of the Turkish Versions of the FABQ TKS, and PCS in Patients With Chronic Neck Pain
A study testing Pain Catastrophizing scale in people with Neck Pain and Kinesiophobia, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
To investigate the reliability and sensitivity of the Fear-Avoidance Beliefs Questionnaire, Tampa Kinesiophobia Scale, and Pain Catastrophizing Scale in patients with chronic nonspecific neck pain undergoing multidisciplinary rehabilitation and to determine the most appropriate minimally clinically significant… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Kinesiophobia, Fear of Movement
- What is being tested?
- Pain Catastrophizing scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to Dec 2025
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Systemic disease, cognitive impairment (Mini Mental State Examination <24),
- Recent (<12 weeks) myocardial infarction, cerebrovascular accident
- Rheumatoid arthritis, neurological disorders, radiculopathy, infection, tumor, osteoporosis, vertebral fracture, trauma and surgery in the cervical region.
- Having previously received any exercise therapy and/or pain neuroscience training.
- Refusal of treatment or failure to comply with treatment (
Trial locations and contacts
1 site in 1 country.
Irmak çavuşoğlu contact
About this study
Official title: Evaluation of the Responsibility and Minimal Clinical Important Change of the Turkish Versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Kinesiophobia Scale,and Pain Catastrophizing Scale in Patients With Chronic Neck Pain.
To investigate the reliability and sensitivity of the Fear-Avoidance Beliefs Questionnaire, Tampa Kinesiophobia Scale, and Pain Catastrophizing Scale in patients with chronic nonspecific neck pain undergoing multidisciplinary rehabilitation and to determine the most appropriate minimally clinically significant difference values in order to increase confidence in their use in clinical practice and research for this patient population. Therefore, the current study aims to evaluate the answerability and minimal clinical significance of the Turkish versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Kinesiophobia scale, and Pain Catastrophizing scales in patients with non-specific chronic neck pain.
Read the detailed description
To investigate the reliability and sensitivity of the Fear-Avoidance Beliefs Questionnaire, Tampa Kinesiophobia Scale, and Pain Catastrophizing Scale in patients with chronic nonspecific neck pain undergoing multidisciplinary rehabilitation and to determine the most appropriate minimally clinically significant difference values in order to increase confidence in their use in clinical practice and research for this patient population. Therefore, the current study aims to evaluate the answerability and minimal clinical significance of the Turkish versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Kinesiophobia scale, and Pain Catastrophizing scales in patients with non-specific chronic neck pain.
- Conditions
- Neck Pain, Kinesiophobia, Fear of Movement
- Being tested
- Pain Catastrophizing scale
- Medical subject headings
- Neck Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Catastrophizing scaleOther
Also called Fear-Avoidance Beliefs Questionnaire, and Pain Catastrophizing scale, Tampa Kinesiophobia scale
Participants' fear and avoidance behaviors will be evaluated with the Fear Avoidance Beliefs Questionnaire (KKBS) (Appendix 2).
Participants' fear of movement will be evaluated with the Tampa Kinesiophobia Scale (TKS) (Appendix 3).
Pain Catastrophizing Scale (PAS) (Appendix 4) will be used to evaluate the participants' pain-related thoughts and feelings.
The amount of improvement in symptoms perceived by the participants will be evaluated at the end of the treatment with the Global Perceived Impact Scale (GAES) (Appendix 5). Participants were asked "How would you describe your current situation compared to the beginning of treatment?" question will be asked.
| Study group | Role | What they receive |
|---|---|---|
| İNTERVENTİON | Other | The surveys in the study will be applied to the patients in this group and initial and final measurements will be taken. Receives: Other: Pain Catastrophizing scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear-Avoidance
It is aimed to evaluate the responsibility and minimal clinical significance of the Fear-Avoidance Beliefs Questionnaire in patients with non-specific chronic neck pain.
Measured: baseline and after 8 weeks
Secondary outcomes (2)
Kinesiophobia
It is aimed to evaluate the responsibility and minimal clinical significance of the Turkish versions of the Tampa Kinesiophobia scale in patients with non-specific chronic neck pain.
Measured: baseline and after 8 weeks
Pain Catastrophizing
It is aimed to evaluate the responsibility and minimal clinical significance of the Turkish versions of the Pain Catastrophizing scale in patients with non-specific chronic neck pain.
Measured: baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start15 Jan 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irmak ÇAVUŞOĞLU, Acibadem University
- Investigators
- Nuray Alaca, assoc.prof., Study chair, Acibadem UniversityElif Esma Safran, PhD, Study chair, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194812
- Sponsor's protocol ID
- 2023-19/651
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Responsibility and Minimal Clinical Important Change of the Turkish Versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Kinesiophobia Scale,and Pain Catastrophizing Scale in Patients With Chronic Neck Pain.
- ClinicalTrials.gov ID
- NCT06194812
- Acronym / sponsor ID
- 2023-19/651
- Conditions
- Neck Pain, Kinesiophobia, Fear of Movement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Jan 2024 (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.
To investigate the reliability and sensitivity of the Fear-Avoidance Beliefs Questionnaire, Tampa Kinesiophobia Scale, and Pain Catastrophizing Scale in patients with chronic nonspecific neck pain undergoing multidisciplinary rehabilitation and to determine the most appropriate minimally clinically significant difference values in order to increase confidence in their use in clinical practice and research for this patient population. Therefore, the current study aims to evaluate the answerability and minimal clinical significance of the Turkish versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Kinesiophobia scale, and Pain Catastrophizing scales in patients with non-specific chronic neck pain.
Detailed description
To investigate the reliability and sensitivity of the Fear-Avoidance Beliefs Questionnaire, Tampa Kinesiophobia Scale, and Pain Catastrophizing Scale in patients with chronic nonspecific neck pain undergoing multidisciplinary rehabilitation and to determine the most appropriate minimally clinically significant difference values in order to increase confidence in their use in clinical practice and research for this patient population. Therefore, the current study aims to evaluate the answerability and minimal clinical significance of the Turkish versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Kinesiophobia scale, and Pain Catastrophizing scales in patients with non-specific chronic neck pain.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| İNTERVENTİON | Other | Other: Pain Catastrophizing scaleThe surveys in the study will be applied to the patients in this group and initial and final measurements will be taken. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Systemic disease, cognitive impairment (Mini Mental State Examination <24),
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 Catastrophizing scaleAlso: Fear-Avoidance Beliefs Questionnaire, and Pain Catastrophizing scale, Tampa Kinesiophobia scaleParticipants' fear and avoidance behaviors will be evaluated with the Fear Avoidance Beliefs Questionnaire (KKBS) (Appendix 2). Participants' fear of movement will be evaluated with the Tampa Kinesiophobia Scale (TKS) (Appendix 3). Pain Catastrophizing Scale (PAS) (Appendix 4) will be used to evaluate the participants' pain-related thoughts and feelings. The amount of improvement in symptoms perceived by the participants will be evaluated at the end of the treatment with the Global Perceived Impact Scale (GAES) (Appendix 5). Participants were asked "How would you describe your current situation compared to the beginning of treatment?" question will be asked. | Other | İNTERVENTİON |
Primary outcome
Fear-Avoidance
Time frame: baseline and after 8 weeks
It is aimed to evaluate the responsibility and minimal clinical significance of the Fear-Avoidance Beliefs Questionnaire in patients with non-specific chronic neck pain.
2 secondary outcomes
Kinesiophobia
Time frame: baseline and after 8 weeks
Pain Catastrophizing
Time frame: baseline and after 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
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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.
Irmak çavuşoğlu contact
Nuray Alaca, assoc.prof. study chair
Acibadem University
Elif Esma Safran, PhD study chair
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Catastrophizing scale in people with Neck Pain and Kinesiophobia, run by Acibadem 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 0 inclusion and 5 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 8 Jan 2024. 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 ırmak çavuşoğlu, PhD (05346028050, irmak.cavusoglu@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear-Avoidance (time frame: baseline and after 8 weeks). 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 8 Jan 2024.