NCT07292155

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 5, 2025

Last Update Submit

December 21, 2025

Conditions

Keywords

Myofascial Pain SyndromeCervical PainChronic PainType D PersonalityDistressed PersonalityNegative AffectivitySocial InhibitionPsychological FactorsStigmaAnticipated StigmaChronic Illness StigmaAnxietyDepressionNeck DisabilityHealth-Related Quality of LifePain PsychologyPsychosocial FactorsBiopsychosocial Approach

Outcome Measures

Primary Outcomes (2)

  • 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

    At baseline

  • 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.

    At baseline

Secondary Outcomes (4)

  • Headache Impact Test

    At baseline

  • Neck Disability Index

    At baseline

  • Hospital Anxiety and Depression Scale

    At baseline

  • Short Form 36 Health Survey

    At baseline

Study Arms (2)

Cervical Myofascial Pain Syndrome Group

This 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 Group

This 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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Yozgat, Yozgat, 66100, Turkey (Türkiye)

Location

Related Publications (6)

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

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

    BACKGROUND
  • 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.

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

    BACKGROUND
  • 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.

    PMID: 19770615BACKGROUND
  • 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.

    PMID: 34924791BACKGROUND

MeSH Terms

Conditions

Social StigmaAnxiety DisordersDepressionMyofascial Pain SyndromesNeck PainChronic Pain

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorMental DisordersBehavioral SymptomsMuscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, Principal Investigator

Study Record Dates

First Submitted

December 5, 2025

First Posted

December 18, 2025

Study Start

July 3, 2025

Primary Completion

October 6, 2025

Study Completion

October 6, 2025

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The IPD and related materials will be available beginning 6 months after publication of the article and will remain accessible for 3 years following publication.
Access Criteria
Researchers who submit a reasonable request describing a methodologically sound proposal for data use may obtain access to de-identified data. Requests should be directed to the corresponding author at the email address listed in the publication. Data will be shared electronically via secure file transfer after approval of the request.
More information

Locations