AzTrials
AzTrials

Cervical Myofascial Pain SyndromeNCT07292155

Type D Personality, and Stigma in Myofascial Pain Syndrome

An observational study of Cervical Myofascial Pain Syndrome and Chronic Neck Pain, run by Gulseren Demir Karakilic at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Cervical myofascial pain syndrome is a chronic musculoskeletal condition characterized by the presence of sensitive trigger points and taut muscle bands, resulting in localized or referred pain, muscle stiffness, and limited range of motion. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
How many people
54 participants
Where
1 siteTurkey (Türkiye)
Study dates
3 Jul 2025to 6 Oct 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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study population consisted of adult outpatients aged 18-65 years who were diagnosed with cervical myofascial pain syndrome and healthy volunteers matched by age, sex, and education level. All participants were recruited from the Departments of Neurology and Physical Medicine and Rehabilitation at Bozok University Faculty of Medicine. Written informed consent was obtained from each participant after verbal and written explanations of the study procedures.

Who may be able to join

  • Adults aged 18 to 65 years.
  • Patients diagnosed with cervical myofascial pain syndrome according to Travell and Simons criteria:
  • localized pain at rest,
  • referred pain or altered sensation in the typical referral zone of a trigger point,
  • a palpable taut band containing a hypersensitive tender spot, and
  • restricted range of motion of the affected muscle.
Show all 10Show fewer
  • Duration of symptoms for at least six months.
  • Outpatients followed in the Department of Physical Medicine and Rehabilitation.
  • Voluntary participation and provision of written informed consent.
  • Healthy control participants matched by age, sex, and education, without musculoskeletal or systemic diseases.

Who cannot join

  • History of cervical disc herniation, radiculopathy, or myelopathy.
  • Presence of systemic or rheumatologic diseases.
  • Current psychiatric or neurological disorders such as schizophrenia, bipolar disorder, dementia, epilepsy, autism, or intellectual disability.
  • Use of psychotropic medication or ongoing psychiatric treatment.
  • History of major surgery or trauma involving the cervical region.
  • Pregnancy or lactation.
  • Inability to complete questionnaires due to cognitive or language barriers.
  • Refusal or withdrawal of informed consent.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation

    Yozgat, Yozgat, 66100

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Prevalence of Type D Personality and Stigma in Patients With Cervical Myofascial Pain Syndrome

Cervical myofascial pain syndrome is a chronic musculoskeletal condition characterized by the presence of sensitive trigger points and taut muscle bands, resulting in localized or referred pain, muscle stiffness, and limited range of motion. The disorder frequently leads to functional limitations and a reduction in quality of life. Although the physical features of cervical myofascial pain syndrome have been well documented, its psychological and social dimensions have not been adequately explored. Personality traits and social factors may influence pain perception, coping mechanisms, and treatment adherence. Type D personality, also known as distressed personality, is defined by the coexistence of negative emotions and social inhibition and has been associated with worse outcomes in various chronic diseases. Stigma represents another psychosocial factor that may contribute to disability and emotional distress in chronic pain conditions.

This case-control study aims to investigate the prevalence of Type D personality traits and anticipated stigma among patients with cervical myofascial pain syndrome compared with healthy individuals. The study further explores the relationships between personality type, stigma, and clinical and psychological parameters, including anxiety, depression, disability, and health-related quality of life. Findings are expected to support a more comprehensive, biopsychosocial understanding of cervical myofascial pain syndrome and emphasize the importance of psychological screening and social support in clinical management.

Read the detailed description

Cervical myofascial pain syndrome is a non-inflammatory pain disorder associated with painful trigger points in skeletal muscles of the neck and shoulder region. It is characterized by regional pain, restricted neck mobility, muscle tightness, fatigue, and autonomic symptoms such as increased sweating or dizziness. The condition is common among adults, particularly women, and often coexists with other chronic pain syndromes such as tension-type headache or fibromyalgia. Because there are no specific laboratory or imaging tests, diagnosis is based on detailed clinical examination and symptom evaluation. The persistence of pain can lead to emotional distress, sleep disturbance, and significant impairment in daily activities.

Personality and psychosocial factors are known to play important roles in chronic pain perception and coping. Type D personality, defined by the presence of both negative affectivity and social inhibition, has been shown to negatively influence health behaviors and quality of life in several chronic disorders. Individuals with this personality type tend to experience anxiety, irritability, and social withdrawal, which may exacerbate pain-related disability and emotional burden. Another relevant factor is stigma, which refers to social devaluation or exclusion based on illness. Patients with chronic pain may internalize stigma, leading to shame, reduced help-seeking behavior, and decreased treatment adherence. Despite its relevance, stigma has not been investigated in patients with cervical myofascial pain syndrome. This study seeks to fill that gap by assessing both Type D personality and anticipated stigma in this patient population.

Materials and Methods

This case-control study was conducted between July 2025 and October 2025 at the Departments of Neurology and Physical Medicine and Rehabilitation, Bozok University Faculty of Medicine, Yozgat, Turkey. Ethical approval was obtained from the Bozok University Clinical Research Ethics Committee (Approval No: 2025-GOKAEK-2513_2025.07.02_505). All participants provided written informed consent before inclusion.

Participants

The study included outpatients aged 18 to 65 years who were clinically diagnosed with cervical myofascial pain syndrome for at least six months. Diagnosis was made according to established clinical criteria, including localized pain at rest, referred pain from a palpable taut band, a hypersensitive tender spot within the affected muscle, and restricted range of motion. The control group consisted of healthy volunteers matched by age, sex, and education level. Exclusion criteria included systemic diseases, rheumatologic or neurologic disorders, psychiatric conditions such as schizophrenia or bipolar disorder, cervical disc herniation, radiculopathy, myelopathy, and use of psychotropic medication.

Data Collection and Instruments

Demographic and clinical data were recorded using a structured questionnaire that included information on age, sex, marital status, educational level, occupation, and disease duration. Participants completed a set of standardized, validated instruments administered face-to-face by trained healthcare professionals:

Headache Impact Test (HIT-6): Assesses the degree to which headaches affect daily activities, including pain intensity, social and cognitive functioning, and emotional well-being. Higher scores indicate greater impact.

Neck Disability Index (NDI): Measures the extent to which neck pain interferes with everyday activities such as reading, working, sleeping, and recreation.

Hospital Anxiety and Depression Scale (HADS): Evaluates symptoms of anxiety and depression over the previous week through two subscales.

Type D Personality Scale (TDPS): A 14-item instrument assessing negative affectivity and social inhibition. Scores equal to or higher than ten on both subscales indicate the presence of Type D personality traits.

Chronic Illness Anticipated Stigma Scale (CIASS): A 12-item scale assessing expected stigma from family and friends, the workplace, and healthcare providers. Each item is rated on a five-point Likert scale, with higher scores representing greater perceived stigma.

Short Form-36 Health Survey (SF-36): Evaluates health-related quality of life across eight domains, including physical functioning, vitality, social functioning, and mental health. Higher scores denote better perceived health status.

Keywords
Myofascial Pain Syndrome, Cervical Pain, Chronic Pain, Type D Personality, Distressed Personality, Negative Affectivity, Social Inhibition, Psychological Factors, Stigma, Anticipated Stigma, Chronic Illness Stigma, Anxiety, Depression, Neck Disability, Health-Related Quality of Life, Pain Psychology, Psychosocial Factors, Biopsychosocial Approach
Medical subject headings
Social Stigma, Anxiety Disorders, Depression, Myofascial Pain Syndromes, Neck Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07292155
Study groupRoleWhat they receive
Cervical Myofascial Pain Syndrome GroupThis group includes adults between 18 and 65 years of age who were clinically diagnosed with cervical myofascial pain syndrome for at least six months. Participants were evaluated at the Departments of Neurology and Physical Medicine and Rehabilitation at Bozok University. Each participant completed a detailed clinical and psychosocial assessment using standardized questionnaires, including the Headache Impact Test, the Neck Disability Index, the Hospital Anxiety and Depression Scale, the Type D Personality Scale, the Chronic Illness Anticipated Stigma Scale, and the Short Form 36 Health Survey. These assessments were used to evaluate pain severity, neck-related disability, emotional status, personality traits, perceived stigma, and quality of life.
Healthy Control GroupThis group includes healthy volunteers who were matched to the patient group by age, sex, and education level. Individuals in this group did not have any musculoskeletal, rheumatologic, neurological, or psychiatric disorders. They completed the same assessment battery as the patient group, including the Headache Impact Test, the Neck Disability Index, the Hospital Anxiety and Depression Scale, the Type D Personality Scale, the Chronic Illness Anticipated Stigma Scale, and the Short Form 36 Health Survey, in order to allow direct comparison of psychological and functional characteristics between groups.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Type D Personality Scale

    The Type D Personality Scale is a 14-item self-report instrument assessing two stable personality traits: negative affectivity and social inhibition. Each item is rated on a five-point scale ranging from 0 (false) to 4 (true). Subscale scores range from 0 to 28. Individuals scoring 10 or higher on both subscales are classified as having Type D personality. A validated Turkish version of the scale is available

    Measured: At baseline

  2. Chronic Illness Anticipated Stigma Scale

    The Chronic Illness Anticipated Stigma Scale is a 12-item questionnaire measuring anticipated stigma across three domains: family and friends, work environment, and healthcare providers. Each item is rated on a five-point Likert scale ranging from 1 (very unlikely) to 5 (very likely). Subscale scores range from 4 to 20, and total scores range from 12 to 60, with higher scores indicating greater perceived stigma. A validated Turkish version of the scale is available.

    Measured: At baseline

Secondary outcomes (4)
  1. Headache Impact Test

    The Headache Impact Test consists of six items evaluating the impact of headache on daily functioning, including pain severity, role limitations, social functioning, vitality, cognitive functioning, and psychological distress. Each item is scored from 6 to 13, resulting in a total score ranging from 36 to 78. Higher scores indicate greater headache-related impact. A validated Turkish version of the test is available.

    Measured: At baseline

  2. Neck Disability Index

    The Neck Disability Index is a 10-item questionnaire assessing the impact of neck pain on activities of daily living such as reading, work, sleep, and recreation. Each item is scored from 0 (no disability) to 5 (complete disability), yielding a total score between 0 and 50. Higher scores indicate greater disability. A validated Turkish version of the index is available.

    Measured: At baseline

  3. Hospital Anxiety and Depression Scale

    The Hospital Anxiety and Depression Scale is a 14-item questionnaire consisting of two subscales that assess anxiety and depression symptoms. Each item is scored from 0 to 3, producing subscale scores ranging from 0 to 21. Higher scores indicate greater symptom severity. A validated Turkish version of the scale is available.

    Measured: At baseline

  4. Short Form 36 Health Survey

    The Short Form 36 Health Survey is a generic 36-item instrument that evaluates health-related quality of life across eight domains, including physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Domain scores range from 0 to 100, with higher scores reflecting better perceived health status. A validated Turkish version of the survey is available.

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2025
  2. Study start3 Jul 2025
  3. Primary completion6 Oct 2025
  4. Study completion6 Oct 2025

Resources

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
Case-control
Time perspective
Cross-sectional
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07292155
Sponsor's protocol ID
2025-GOKAEK-2513_2025.07.02505
Status last verified
Dec 2025
First submitted
5 Dec 2025
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) that support the findings of this study will be made available upon reasonable request from qualified researchers. The shared data will include variables used for statistical analyses, demographic information, and scale scores collected during the study.

Publications

  • Kocyigit, H., Turkish validity and reliability of short-form 36. Drug Treat, 1999. 12: p. 102-106.

  • Tünerir, E., Kronik hastalıklarda beklenen stigma ölçeğinin Türkçe geçerlilik ve güvenilirlik çalışması (Tıpta uzmanlık tezi). Sağlık Bilimleri Üniversitesi, İstanbul, 2019.

  • Öncü, E. and S.K. Vayısoğlu, D Tipi Kişilik Ölçeğinin Türk toplumunda geçerlilik ve güvenirlilik çalışması. Ankara Medical Journal, 2018. 18(4): p. 646-656.

  • Aydemir, O., Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. Turk Psikiyatri Derg., 1997. 8: p. 187-280.

  • Telci EA, Karaduman A, Yakut Y, Aras B, Simsek IE, Yagli N. The cultural adaptation, reliability, and validity of neck disability index in patients with neck pain: a Turkish version study. Spine (Phila Pa 1976). 2009 Jul 15;34(16):1732-5. doi: 10.1097/BRS.0b013e3181ac9055.

    PubMed 19770615
  • Dikmen PY, Bozdag M, Gunes M, Kosak S, Tasdelen B, Uluduz D, Ozge A. Reliability and Validity of Turkish Version of Headache Impact Test (HIT-6) in Patients with Migraine. Noro Psikiyatr Ars. 2020 Apr 24;58(4):300-307. doi: 10.29399/npa.24956. eCollection 2021.

    PubMed 34924791

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Myofascial Pain Syndrome and Chronic Neck Pain, run by Gulseren Demir Karakilic 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 10 inclusion and 8 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 29 Dec 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?

Type D Personality Scale (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07292155, which also lists 6 linked publications.

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 29 Dec 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in