Neck Pain ChronicNCT06946862
Factors Affecting Treatment Expectations in Chronic Neck Pain
An observational study of Neck Pain Chronic, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine which factors affect treatment expectations in individuals with chronic neck pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neck Pain Chronic
- What is being tested?
- no treatment, medication or intervention
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 Aug 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: neck pain chronic
Who may be able to join
- Having been diagnosed with chronic neck pain by a Physical Medicine and Rehabilitation Specialist
- Being between 18 and 80 years of age
- Signing a consent form after receiving verbal information
Who cannot join
- Presence of instability in the neck joints
- Trauma within the last year
- Advanced osteoporosis
- Previous neck surgery
- Physical therapy within the last 6 months
- Neurological findings or radiculopathy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kto Karatay Üniversitesi
Karatay, Konya, 42000
About this study
Official title: Investigation of Factors Influencing Treatment Expectations in Individuals With Chronic Neck Pain
The aim of this study was to determine which factors affect treatment expectations in individuals with chronic neck pain.
Read the detailed description
This study aims to investigate the factors that influence treatment expectations in individuals with chronic neck pain.
Neck pain is one of the most common musculoskeletal conditions and a major public health issue that significantly affects quality of life and imposes economic burdens due to healthcare costs and productivity loss. It is considered the fourth leading cause of disability worldwide. Chronic neck pain is increasingly prevalent due to modern lifestyle factors, such as prolonged use of smartphones and computers, and is most often classified as nonspecific, mechanical, or postural in origin.
Numerous biopsychosocial factors have been associated with the onset and persistence of neck pain, including age, gender, occupation, duration of sitting or sedentary work, smoking, stress, anxiety, depression, personality traits, emotional state, and levels of physical activity.
Treatment expectations are a key determinant of treatment response and clinical outcomes in musculoskeletal disorders. Positive expectations have been shown to enhance treatment effects, while negative expectations (nocebo effects) may worsen outcomes. Understanding these expectations may aid in tailoring treatment approaches and improving communication between patients and healthcare providers.
This study will evaluate demographic, psychological, and behavioral factors that may influence the treatment expectations of patients with chronic neck pain. The findings may contribute to improving treatment planning, patient education, and shared decision-making in clinical practice.
- Conditions
- Neck Pain Chronic
- Being tested
- no treatment, medication or intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no treatment, medication or interventionOther
will make an observational assessment of the participants' treatment expectations. Participants will not be subjected to any treatment or intervention, only their current situation will be observed.
| Study group | Role | What they receive |
|---|---|---|
| Cohort1-Chronic Neck Pain Group | Participants in this cohort are adults diagnosed with chronic neck pain lasting longer than three months. They may experience nonspecific mechanical or postural neck pain without any specific underlying pathology. Individuals with chronic neck pain of varying severity levels who meet the inclusion criteria are included in this group. Receives: Other: no treatment, medication or intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Expectation Questionnaire
Developed by Shedden-Mora et al. (2023) (15), it is a psychological assessment tool used to measure patients' expectations about treatment before starting a treatment process. The Turkish validity and reliability study of the questionnaire was conducted by Çakır et al. (2024) (24). Validity Measurements The main items of the questionnaire, which consists of 15 main items and 6 additional questions, are structured as a scale in which the patient marks his/her expectation between 0 and 10. The questionnaire consists of treatment benefit (items 1-3), positive effect (items 4-6), negative events (items 7-9), negative effect (items 10-11), process (items 12-13) and behaviour control (items 14-15) subscales.
Measured: Baseline
Secondary outcomes (4)
Pain Beliefs Scale
It was developed by Edwards et al. (1992) to evaluate beliefs about the cause and treatment of pain (25). The Turkish validity and reliability study of the questionnaire was conducted by Berk (2006). The scale has a total of 12 items and consists of two test domains: 8-item Organic Beliefs and 4-item Psychological Beliefs. Participants are asked to tick the most appropriate one for themselves from 6 options ranging from 1. 'never' to 6. 'always'. Each item is given a score between 1 and 6, and the score of each subtest is calculated by averaging the scores of the items belonging to that subtest. There is no cut-off point for the scale and high scores indicate high pain beliefs and low scores indicate low pain beliefs. The highest score for organic and psychological beliefs is 6 and the lowest score is 1.
Measured: Baseline
Pain Self-Efficacy Questionnaire
It is a questionnaire developed by Michael K. Nicholas (1989), consisting of 10 items, easy to understand, can be applied without taking time, evaluates the role of pain in establishing social relationships, doing hobbies or housework, and questions the use of analgesics in coping with pain. The Turkish validity and reliability study of the questionnaire was conducted by Doğan (2019). Individuals with chronic pain are asked to score how safely they can perform the defined activities despite their pain. Scoring is done on a 7-point Likert scale, where 0 = 'completely unsafe' and 6 = 'completely safe'. By summing the scores of 10 items, a high score indicates a strong self-efficacy belief according to the total score between 0 and 60.
Measured: Baseline
Hospital Anxiety and Depression Scale
It was developed by Zigmond and Snaith (1983) to determine the risk of anxiety and depression and to measure the level and change in severity. The Turkish validity and reliability study of the scale was conducted by Aydemir et al. (1997) (30). It consists of 14 items, 7 of which investigate symptoms of depression and 7 of which investigate symptoms of anxiety. Odd numbers measure anxiety and even numbers measure depression. Responses are evaluated in a 4-point Likert scale and scored between 0-3. Patients score between 0 and 21 on both subscales. The cut-off points of the Turkish form of the HADÖ were determined as 10 for the anxiety subscale and 7 for the depression subscale. Scores above these values are considered as risk for depression and anxiety.
Measured: Baseline
Visual Analogue Scale
It is a scale developed by Price et al. (1983) to measure the severity of pain in individuals. The scale consists of a 10 cm horizontally positioned line on the page. The number '0', which is the starting point on this line, represents that the patient does not feel any pain, and the number '10' represents the worst pain experienced by the patient within his/her own experience. The patient is asked to mark anywhere on this straight line between 0 and 10 to indicate the pain he/she had at the time the test was administered. Then, with the help of a ruler, the distance of the point marked by the patient to the starting point, the number 0, is measured in cm and the intensity of the pain is determined.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 May 2025
- Primary completion1 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck Pain 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Burcu DURSUN, Lecturer, Principal investigator, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946862
- Sponsor's protocol ID
- KaratayUBD2
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data from this study will be shared upon reasonable request after the completion and publication of the study results. All data will be anonymized to ensure participant confidentiality and privacy. Data sharing will be subject to approval by the study investigators and may require a data use agreement to protect sensitive information.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Factors Influencing Treatment Expectations in Individuals With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT06946862
- Acronym / sponsor ID
- KaratayUBD2
- Conditions
- Neck Pain Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 27 Apr 2025 (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 determine which factors affect treatment expectations in individuals with chronic neck pain.
Detailed description
This study aims to investigate the factors that influence treatment expectations in individuals with chronic neck pain.
Neck pain is one of the most common musculoskeletal conditions and a major public health issue that significantly affects quality of life and imposes economic burdens due to healthcare costs and productivity loss. It is considered the fourth leading cause of disability worldwide. Chronic neck pain is increasingly prevalent due to modern lifestyle factors, such as prolonged use of smartphones and computers, and is most often classified as nonspecific, mechanical, or postural in origin.
Numerous biopsychosocial factors have been associated with the onset and persistence of neck pain, including age, gender, occupation, duration of sitting or sedentary work, smoking, stress, anxiety, depression, personality traits, emotional state, and levels of physical activity.
Treatment expectations are a key determinant of treatment response and clinical outcomes in musculoskeletal disorders. Positive expectations have been shown to enhance treatment effects, while negative expectations (nocebo effects) may worsen outcomes. Understanding these expectations may aid in tailoring treatment approaches and improving communication between patients and healthcare providers.
This study will evaluate demographic, psychological, and behavioral factors that may influence the treatment expectations of patients with chronic neck pain. The findings may contribute to improving treatment planning, patient education, and shared decision-making in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort1-Chronic Neck Pain Group | – | Other: no treatment, medication or interventionParticipants in this cohort are adults diagnosed with chronic neck pain lasting longer than three months. They may experience nonspecific mechanical or postural neck pain without any specific underlying pathology. Individuals with chronic neck pain of varying severity levels who meet the inclusion criteria are included in this group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- neck pain chronic
Key inclusion criteria (3 listed)
- Having been diagnosed with chronic neck pain by a Physical Medicine and Rehabilitation Specialist
- Being between 18 and 80 years of age
- Signing a consent form after receiving verbal information
Key exclusion criteria (6 listed)
- Presence of instability in the neck joints
- Trauma within the last year
- Advanced osteoporosis
- Previous neck surgery
- Physical therapy within the last 6 months
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 |
|---|---|---|
| no treatment, medication or interventionwill make an observational assessment of the participants' treatment expectations. Participants will not be subjected to any treatment or intervention, only their current situation will be observed. | Other | Cohort1-Chronic Neck Pain Group |
Primary outcome
Treatment Expectation Questionnaire
Time frame: Baseline
Developed by Shedden-Mora et al. (2023) (15), it is a psychological assessment tool used to measure patients' expectations about treatment before starting a treatment process. The Turkish validity and reliability study of the questionnaire was conducted by Çakır et al. (2024) (24). Validity Measurements The main items of the questionnaire, which consists of 15 main items and 6 additional questions, are structured as a scale in which the patient marks his/her expectation between 0 and 10. The questionnaire consists of treatment benefit (items 1-3), positive effect (items 4-6), negative events (items 7-9), negative effect (items 10-11), process (items 12-13) and behaviour control (items 14-15) subscales.
4 secondary outcomes
Pain Beliefs Scale
Time frame: Baseline
Pain Self-Efficacy Questionnaire
Time frame: Baseline
Hospital Anxiety and Depression Scale
Time frame: Baseline
Visual Analogue Scale
Time frame: Baseline
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 6 Aug 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data from this study will be shared upon reasonable request after the completion and publication of the study results. All data will be anonymized to ensure participant confidentiality and privacy. Data sharing will be subject to approval by the study investigators and may require a data use agreement to protect sensitive information.
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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.
Burcu DURSUN, Lecturer principal investigator
KTO Karatay 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 Neck Pain Chronic, run by KTO Karatay 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 6 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 6 Aug 2025. 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?
Treatment Expectation Questionnaire (time frame: Baseline). 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 6 Aug 2025.