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NCT Number: NCT07446504

Association of Pain With Body Image and Psychological Resilience in Rheumatoid Arthritis and Fibromyalgia

This cross-sectional, comparative study will examine the relationship between psychological resilience and body image in patients with rheumatoid arthritis (RA) and fibromyalgia (FM), and compare these findings with healthy controls. Participants will be recruited consecutively from the Physical Medicine and Rehabilitation outpatient clinic at Samsun Training and Research Hospital. After informed consent, demographic and clinical information will be recorded and validated questionnaires will be administered. The results may help to better understand psychological and body-related experiences in RA and FM and support more comprehensive patient care.

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Key information

About this study

Rheumatoid arthritis (RA) is a chronic inflammatory painful disease frequently accompanied by persistent pain, functional limitations, fatigue, and psychological distress. Fibromyalgia (FM) is characterized by chronic widespread pain and multiple symptoms including fatigue, non-restorative sleep, and cognitive complaints; psychological and social factors may also contribute to symptom burden. In both conditions, altered pain processing and central sensitization may influence symptom severity and daily functioning. Body image refers to an individual's perceptions, feelings, and thoughts about their own body, including appearance and physical functioning; chronic pain and disability can negatively affect body image and quality of life.

Objective: The primary aim of this study is to investigate, in a cross-sectional and comparative manner, the association between psychological resilience and body image in RA and FM, and to compare results with a healthy control group.

Design and Setting: Cross-sectional, comparative study conducted in the Physical Medicine and Rehabilitation Clinic at Samsun Training and Research Hospital.

Participants: Adults aged 18-65 years. The study will include approximately 42 participants with FM (meeting ACR 2016 criteria), 42 participants with RA (meeting ACR criteria; disease activity assessed using DAS28), and 40 healthy controls without a history of chronic pain or chronic disease.

Procedures and Measures: After written informed consent, demographic variables (age, sex, height, weight, body mass index, occupation, education), comorbidities, and medication use will be recorded. Participants will complete validated instruments including the Connor-Davidson Resilience Scale (CD-RISC), Body Image Scale (BIS), Beck Depression Inventory (BDI), Central Sensitization Inventory (CSI), Short Form-36 (SF-36), Somatosensory Amplification Scale (SAS), and the Revised Fibromyalgia Impact Questionnaire (FIQR) (FM group). Somatosensory assessment will be performed using the Two-Point Discrimination test. RA disease activity will be evaluated using DAS28.

Sample Size: Power analysis (G*Power) indicated a minimum total sample size of approximately 102 participants (34 per group).

Statistical Analysis: Group comparisons will be performed using appropriate parametric or non-parametric tests based on data distribution. Associations between resilience, body image, central sensitization, sensory measures, and quality-of-life outcomes will be assessed using correlation analyses. A p-value <0.05 will be considered statistically significant.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18-70 years.
  • For the fibromyalgia group: meeting the ACR 2016 criteria.
  • For the rheumatoid arthritis group: meeting the ACR classification/diagnostic criteria.
  • For the healthy control group: no history of chronic pain or chronic disease.
  • Willingness to participate and provision of written informed consent.

Exclusion criteria

  • Presence of an acute or chronic neurological disease.
  • Current or past psychiatric diagnosis.
  • Severe visual or hearing impairment.
  • History of trauma or surgery within the past 6 months.
  • History of cancer.
  • Thyroid disease.
  • Refusal to participate / inability to provide informed consent.

Treatment and study plan

Primary outcomes

  1. Body Image Perception

    Time frame: At enrollment (single visit).

    Body image perception measured using the Body Image Scale; scores will be compared between rheumatoid arthritis, fibromyalgia, and healthy control groups.

  2. Body Image Perception

    Time frame: At enrollment (single visit).

    Body image perception measured by the Body Image Scale (BIS); comparison of BIS scores between rheumatoid arthritis, fibromyalgia, and healthy control groups.

Secondary outcomes

  1. Psychological Resilience (Connor-Davidson Resilience Scale, CD-RISC)

    Time frame: At enrollment (single visit).

    Psychological resilience assessed using the Connor-Davidson Resilience Scale (CD-RISC); scores compared between groups and correlated with BIS.

  2. Somatosensory Amplification (Somatosensory Amplification Scale, SAS)

    Time frame: At enrollment (single visit).

    Tendency to amplify bodily sensations assessed using the Somatosensory Amplification Scale (SAS); scores compared between groups and analyzed for association with BIS.

  3. Depressive Symptoms (Beck Depression Inventory, BDI)

    Time frame: At enrollment (single visit).

    Depressive symptom severity assessed using the Beck Depression Inventory (BDI); scores compared between groups and analyzed for association with BIS.

  4. Two-Point Discrimination Threshold (2PD)

    Time frame: At enrollment (single visit).

    Somatosensory function assessed by the Two-Point Discrimination test; discrimination threshold values will be compared between groups and analyzed for association with Body Image Scale scores and Central Sensitization Inventory scores.

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

The Relationship Between Pain, Psychological Resilience, and Body Image Perception in Patients With Rheumatoid Arthritis and Fibromyalgia: A Cross-Sectional Comparative Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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