Investigation of Pain Modulation Phenotypes in Female Patients With Fibromyalgia
2026年6月5日 更新者：Feyza Nur Yucel、Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Fibromyalgia is characterized by altered pain processing, including impaired descending pain inhibition and central sensitization.
While both mechanisms have been independently associated with disease severity, their interrelationship remains unclear.
This cross-sectional study aims to investigate whether central sensitization symptoms mediate the relationship between conditioned pain modulation and fibromyalgia impact.
調査の概要
状態
まだ募集していません
詳細な説明
Fibromyalgia is characterized by altered pain processing mechanisms, including impaired descending pain inhibition and central sensitization. Although both mechanisms have been independently associated with symptom severity and functional impairment, their interrelationship and relative contributions to disease impact are not fully understood.
This study aims to examine the associations between conditioned pain modulation, central sensitization symptoms, and fibromyalgia impact. In particular, the study evaluates whether central sensitization symptoms act as a mediator in the relationship between impaired pain modulation and clinical disease burden. Participants with fibromyalgia are assessed using standardized clinical and psychological measures, including the Fibromyalgia Impact Questionnaire, Central Sensitization Inventory, and Hospital Anxiety and Depression Scale. Quantitative sensory testing is performed to evaluate conditioned pain modulation, pressure pain threshold, and temporal summation.Statistical analyses are conducted to explore bivariate associations and to identify independent predictors of fibromyalgia impact. A mediation framework is applied to assess whether central sensitization symptoms explain the relationship between pain modulation and clinical outcomes.
研究の種類
観察的
入学 (推定)
82
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Feyza Nur Yücel, Assoc. Prof.
- 電話番号：+90 (0216) 542 20 00
- メール：dr.fny28@gmail.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
The study population will consist of female patients who presented to the Physical Medicine and Rehabilitation Clinic and received a diagnosis of FM.
説明
Inclusion Criteria:
- Having received a diagnosis of fibromyalgia according to the 2016 ACR diagnostic criteria
- Female patients aged 18-65
- Being literate
- Having signed the informed consent form upon agreeing to participate in the study
Exclusion Criteria:
- Being under 18 or over 65 years of age
- Having any condition that may lower the pain threshold or cause chronic pain (Rheumatoid Arthritis, Ankylosing Spondylitis, systemic inflammatory diseases, malignancies, etc.)
- Any neurological condition (stroke, traumatic brain injury, multiple sclerosis, Parkinson's disease, central nervous system malignancies…)
- Peripheral artery disease
- Severe cardiopulmonary insufficiency (stage 3-4)
- Uncontrolled systemic diseases such as hypertension and diabetes
- Presence of an active infection
- Pregnancy
- Presence of cognitive impairment, hearing loss, or communication difficulties that would prevent understanding of questionnaires and protocols
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Patient
Women with Fibromyalgia
|
including PPT Measurement with an Algometer, CPM and the Slow-Repeated Stimulated Pain Assessment Protocol
Central Sensitization Inventory, Revised Fibromyalgia Impact Questionnaire, S-LANSS, Tampa Kinesiophobia Scale, Hospital Anxiety and Depression Scale, SF-12 Quality of Life Scale and Fatigue Severity Scale
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Conditioned Pain Modulation
時間枠：Baseline
|
Objective determination of the pain modulation phenotype and the severity of central sensitization.
Scores above 100 are considered a normal CPM response; higher scores indicate greater pain inhibition.
|
Baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pressure Pain Threshold
時間枠：Baseline
|
Lower values are associated with pain sensitization
|
Baseline
|
|
Slowly Repeated Evoked Pain Assessment Protocol
時間枠：Baseline
|
The SREP protocol consists of 9 painful stimuli above the pain threshold, each applied to the nail for 5 seconds at approximately 30-second intervals.
|
Baseline
|
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Central Sensitization Inventory
時間枠：Baseline
|
It is preferred for investigating pain sensitivity through symptoms associated with CS and related comorbidities.
CS severity can be classified into 5 different groups based on the score obtained from Section A of the scale: scores of 0-21 indicate a subclinical level, 22-30 indicate a mild level, 31-37 indicate a moderate level, 38-51 indicate a severe level, and scores above 51 indicate a very severe level of CS .
|
Baseline
|
|
Revised Fibromyalgia Impact Questionnaire
時間枠：Baseline
|
It consists of three sections-daily physical activities, general condition, and symptoms-and a total of 21 questions.
It assesses limitations and functional disability in patients with fibromyalgia.
All questions are rated on a 0-10-point Visual Analog Scale (VAS).
A higher total score indicates an increase in disability associated with fibromyalgia.
|
Baseline
|
|
Self-administered Leeds Assessment of Neuropathic Symptoms and Signs
時間枠：Baseline
|
The Neuropathic Symptoms and Signs Questionnaire is a 7-item self-report questionnaire completed by the individual, scored on a scale of 0 to 24.
A score of 12 or higher indicates the likelihood of neuropathic pain .
|
Baseline
|
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Tampa Kinesiophobia Scale
時間枠：Baseline
|
A 17-item questionnaire developed to measure the fear of movement and re-injury .
The total score ranges from 17 to 68.
Higher scores are associated with an increase in kinesiophobia.
|
Baseline
|
|
Hospital Anxiety and Depression Scale
時間枠：Baseline
|
It consists of a total of 14 items, with 7 items each for anxiety and depression.
Scores for the anxiety and depression subscales range from 0 to 21. Scores between 8 and 10 indicate moderate symptom presence, while a score greater than 11 indicates anxiety and depression symptoms that likely correspond to a clinical diagnosis.
|
Baseline
|
|
SF-12 Quality of Life Scale
時間枠：Baseline
|
It was developed to assess health-related quality of life.
Two separate scores are obtained: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
The physical score reflects the individual's perception of overall health, physical limitations, and pain levels.
The mental score, on the other hand, reflects the individual's emotional problems, energy levels, and social activities.
|
Baseline
|
|
Fatigue Severity Scale
時間枠：Baseline
|
This is a 9-item questionnaire in which each item is rated on a scale of 1 to 7; it assesses the severity, frequency, and impact of fatigue on daily life.
The total score ranges from 7 to 63.
As the score decreases, fatigue decreases.
|
Baseline
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Feyza Nur Yücel, Assoc. Prof.、Saglik Bilimleri Universitesi
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30.
- Yarnitsky D, Bouhassira D, Drewes AM, Fillingim RB, Granot M, Hansson P, Landau R, Marchand S, Matre D, Nilsen KB, Stubhaug A, Treede RD, Wilder-Smith OH. Recommendations on practice of conditioned pain modulation (CPM) testing. Eur J Pain. 2015 Jul;19(6):805-6. doi: 10.1002/ejp.605. Epub 2014 Oct 20.
- Maquet D, Croisier JL, Demoulin C, Crielaard JM. Pressure pain thresholds of tender point sites in patients with fibromyalgia and in healthy controls. Eur J Pain. 2004 Apr;8(2):111-7. doi: 10.1016/S1090-3801(03)00082-X.
- Vincent A, Lahr BD, Wolfe F, Clauw DJ, Whipple MO, Oh TH, Barton DL, St Sauver J. Prevalence of fibromyalgia: a population-based study in Olmsted County, Minnesota, utilizing the Rochester Epidemiology Project. Arthritis Care Res (Hoboken). 2013 May;65(5):786-92. doi: 10.1002/acr.21896.
- Siracusa R, Paola RD, Cuzzocrea S, Impellizzeri D. Fibromyalgia: Pathogenesis, Mechanisms, Diagnosis and Treatment Options Update. Int J Mol Sci. 2021 Apr 9;22(8):3891. doi: 10.3390/ijms22083891.
- Nijs J, George SZ, Clauw DJ, Fernandez-de-Las-Penas C, Kosek E, Ickmans K, Fernandez-Carnero J, Polli A, Kapreli E, Huysmans E, Cuesta-Vargas AI, Mani R, Lundberg M, Leysen L, Rice D, Sterling M, Curatolo M. Central sensitisation in chronic pain conditions: latest discoveries and their potential for precision medicine. Lancet Rheumatol. 2021 May;3(5):e383-e392. doi: 10.1016/S2665-9913(21)00032-1. Epub 2021 Mar 30.
- Jurado-Priego LN, Cueto-Urena C, Ramirez-Exposito MJ, Martinez-Martos JM. Fibromyalgia: A Review of the Pathophysiological Mechanisms and Multidisciplinary Treatment Strategies. Biomedicines. 2024 Jul 11;12(7):1543. doi: 10.3390/biomedicines12071543.
- Ruschak I, Monteso-Curto P, Rossello L, Aguilar Martin C, Sanchez-Monteso L, Toussaint L. Fibromyalgia Syndrome Pain in Men and Women: A Scoping Review. Healthcare (Basel). 2023 Jan 11;11(2):223. doi: 10.3390/healthcare11020223.
- de la Coba P, Bruehl S, Del Paso GAR. Addition of Slowly Repeated Evoked Pain Responses to Clinical Symptoms Enhances Fibromyalgia Diagnostic Accuracy. Pain Med. 2020 Dec 25;21(12):3479-3487. doi: 10.1093/pm/pnz346.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2026年8月30日
研究の完了 (推定)
2026年9月1日
試験登録日
最初に提出
2026年6月1日
QC基準を満たした最初の提出物
2026年6月5日
最初の投稿 (実際)
2026年6月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月11日
QC基準を満たした最後の更新が送信されました
2026年6月5日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 222222
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Individual participant data collected during this study will not be made available to other researchers.
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