An observational study in Myofascial Pain Syndrome - Neck, sponsored by Mardin Artuklu University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Mardin Artuklu University · Observational
This study aims to investigate how closely two approaches to assessing pain-related characteristics agree in adults with chronic cervical myofascial pain syndrome (chronic neck pain associated with painful muscle trigger points).
The Central Sensitization Inventory (CSI) is a questionnaire that assesses symptoms associated with increased pain sensitivity. The International Association for the Study of Pain (IASP) has developed clinical criteria to identify nociplastic pain, a type of pain that cannot be fully explained by tissue damage or nerve injury. These approaches provide different types of information, and it is unclear how often they classify patients with chronic cervical myofascial pain in the same way.
This observational, cross-sectional study will include 150 adults aged 18 years or older with chronic cervical myofascial pain syndrome.
Participants will undergo a clinical assessment based on the IASP nociplastic pain criteria and complete the CSI, Neck Disability Index (NDI), and Revised Illness Perception Questionnaire (IPQ-R). Pain severity and relevant clinical information will also be recorded.
The main objective is to determine the agreement between CSI classification using a cutoff score of 40 and IASP clinical classification of nociplastic pain.
The study will also examine how often the two approaches produce different classifications and whether patients with matching or differing classifications report different emotional responses to their illness.
All assessments will be completed during a single visit. No experimental treatments or additional invasive procedures will be performed.
Chronic cervical myofascial pain syndrome is characterized by persistent neck pain and tenderness associated with active myofascial trigger points. Although myofascial pain is primarily considered nociceptive, some patients may also exhibit nociplastic pain characteristics that are not fully explained by local muscle findings.
The International Association for the Study of Pain (IASP) has proposed clinical criteria for nociplastic pain affecting the musculoskeletal system. These criteria consider pain duration and distribution, whether pain can be fully explained by nociceptive or neuropathic mechanisms, clinically evoked pain hypersensitivity, and associated symptoms.
The Central Sensitization Inventory (CSI) is a patient-reported questionnaire assessing symptoms associated with central sensitivity syndromes. A cutoff score of 40 is commonly used to distinguish patients with higher symptom burden. However, CSI classification does not necessarily correspond to clinical nociplastic pain classification.
The primary objective of this study is to assess the agreement between CSI classification (scores below 40 versus 40 or higher) and IASP clinical classification (not meeting the criteria versus meeting the criteria for at least possible nociplastic pain) in adults with chronic cervical myofascial pain syndrome.
Agreement will be quantified using Cohen's kappa coefficient with a 95% confidence interval. The original IASP categories (not meeting the criteria, possible nociplastic pain, and probable nociplastic pain) will be retained in the study records.
Secondary objectives include determining the overall frequency of disagreement and identifying both directions of discordance: patients with CSI scores of 40 or higher who do not meet IASP criteria, and patients with CSI scores below 40 who meet the criteria for at least possible nociplastic pain.
The study will also investigate whether illness perception differs among the four groups formed by the combination of CSI and IASP classifications. The primary focus of this secondary analysis will be the emotional representations dimension of the Revised Illness Perception Questionnaire (IPQ-R). Differences will be evaluated while accounting for pain severity measured by the Numeric Rating Scale (NRS) and neck-related disability measured by the Neck Disability Index (NDI).
Other IPQ-R dimensions will be examined in exploratory analyses. An additional agreement analysis will be conducted using only the probable nociplastic pain category as the positive IASP classification.
Clinical assessment will be performed before administration of the patient-reported questionnaires. The clinician performing the IASP assessment will not have access to the CSI or IPQ-R results when determining the clinical classification.
The study will be conducted at the Physical Medicine and Rehabilitation Outpatient Clinic of Mardin Training and Research Hospital, Türkiye. All information will be collected during a single assessment visit.
The findings may help clarify how patient-reported symptoms and clinical nociplastic pain criteria relate to one another and whether
339 studies on the registry are indexed under Myofascial Pain Syndromes; 66 are open to participants now.
This study's planned enrollment of 150 is above the median of 90 across 28 observational studies indexed under Myofascial Pain Syndromes.
Browse Myofascial Pain Syndromes studies →Mardin Artuklu University is the lead sponsor of 34 studies on the registry; 15 are open to participants now.
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The study population will consist of 150 adults aged 18 years or older diagnosed with chronic cervical myofascial pain syndrome who attend the Physical Medicine and Rehabilitation Outpatient Clinic at Mardin Training and Research Hospital, Türkiye. Eligible participants will have neck pain lasting longer than three months. All participants will undergo a single-visit assessment including IASP clinical nociplastic pain classification, the Central Sensitization Inventory (CSI), the Neck Disability Index (NDI), and the Revised Illness Perception Questionnaire (IPQ-R). Patients will be categorized according to their CSI and IASP classifications. No healthy control group will be included.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults aged 18 years or older diagnosed with chronic cervical myofascial pain syndrome and experiencing neck pain for more than three months. Participants will undergo a single-visit clinical assessment based on the International Association for the Study of Pain (IASP) nociplastic pain criteria, followed by the Neck Disability Index (NDI), Central Sensitization Inventory (CSI), and Revised Illness Perception Questionnaire (IPQ-R). Pain severity and demographic and clinical characteristics will also be recorded. CSI and IASP classifications will be compared to assess agreement and disagreement. No experimental treatment or additional invasive procedures will be performed.
Agreement Between CSI and IASP Nociplastic Pain Classifications
Agreement between the Central Sensitization Inventory (CSI) and the International Association for the Study of Pain (IASP) clinical nociplastic pain classification will be quantified using Cohen's kappa coefficient with a 95% confidence interval. CSI scores will be categorized as below 40 or 40 and above. IASP classifications will be dichotomized as not meeting the criteria or meeting the criteria for at least possible nociplastic pain (possible or probable). Cohen's kappa ranges from -1 to 1, with 1 indicating perfect agreement, 0 indicating agreement expected by chance, and negative values indicating less agreement than expected by chance.
Time frame: baseline
Overall Discordance Rate Between CSI and IASP Classifications
The percentage of participants with discordant CSI and IASP classifications will be calculated. Discordance is defined as either a CSI score of 40 or higher without meeting the IASP criteria for nociplastic pain, or a CSI score below 40 while meeting the IASP criteria for at least possible nociplastic pain. The overall discordance rate will be reported as a percentage with a 95% confidence interval calculated using the Wilson method.
Time frame: baseline
Discordance Rate for CSI-Positive and IASP-Negative Classification
The percentage of all evaluated participants with a CSI score of 40 or higher who do not meet the IASP clinical criteria for nociplastic pain will be calculated. This represents one direction of disagreement between the two classification approaches. The proportion will be reported with a 95% confidence interval using the Wilson method.
Time frame: baseline
Discordance Rate for CSI-Negative and IASP-Positive Classification
The percentage of all evaluated participants with a CSI score below 40 who meet the IASP criteria for at least possible nociplastic pain will be calculated. The IASP-positive category includes possible and probable nociplastic pain. This represents the opposite direction of disagreement between the two classification approaches. The proportion will be reported with a 95% confidence interval using the Wilson method.
Time frame: baseline
Differences in IPQ-R Emotional Representations Scores Across CSI-IASP Classification Groups
Emotional responses to illness will be assessed using the Emotional Representations subscale of the Revised Illness Perception Questionnaire (IPQ-R). This subscale consists of 6 items scored from 1 to 5, yielding a total score ranging from 6 to 30. Higher scores indicate stronger negative emotional responses to illness, whereas lower scores indicate fewer negative emotional responses. Scores will be compared across four groups defined by CSI classification (below 40 versus 40 or higher) and IASP classification (not meeting criteria versus at least possible nociplastic pain). Multivariable linear regression will be used to assess group differences after adjustment for pain severity (NRS) and neck-related disability (NDI). Adjusted mean differences and 95% confidence intervals will be reported.
Time frame: baseline
Agreement Between CSI Classification and Probable IASP Nociplastic Pain
An additional agreement analysis will be conducted using only the probable nociplastic pain category as the positive IASP classification. Participants not meeting the IASP criteria and those classified as having possible nociplastic pain will form the comparison category. CSI scores will be classified as below 40 or 40 and above. Agreement will be quantified using Cohen's kappa coefficient with a 95% confidence interval.
Time frame: baseline
IPQ-R Consequences Score Across CSI-IASP Classification Groups
Perceived consequences of illness will be assessed using the Consequences subscale of the Revised Illness Perception Questionnaire (IPQ-R). This subscale consists of 6 items scored from 1 to 5, yielding a total score ranging from 6 to 30. Higher scores indicate greater perceived negative consequences of illness, while lower scores indicate fewer perceived negative consequences. Scores will be compared across the four groups defined by CSI (below 40 versus 40 or higher) and IASP (not meeting criteria versus at least possible nociplastic pain) classifications as an exploratory analysis.
Time frame: baseline
Plan to share: No
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Mardin Artuklu University