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Completed

NCT Number: NCT06658457

Headache in Juvenile Onset Systemic Lupus Erythematosus

The aim of our study was to compare individuals with juvenile onset systemic lupus erythematosus with and without headache in terms of pain, pain catastrophizing behavior, demographic and individual disease-related factors that may affect headache and temporomandibular joint dysfunction.

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Key information

Conditions

Headache Juvenile Systemic Lupus Erythematosus Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pamukkale University

Denizli, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Having been diagnosed with Juvenile Onset Systemic Lupus Erythematosus by the Pediatric Rheumatology Clinic
  • Being between the ages of 8-25,
  • Having stable symptoms and medications
  • Being willing to participate in the study

Exclusion criteria

  • Patients with neuropsychiatric disorders not associated with Juvenile Onset Systemic Lupus Erythematosus (such as history of epilepsy, electrolyte imbalance, or medication side effects)
  • History of headache before juvenile onset systemic lupus erythematosus diagnosis
  • Presence of another concomitant rheumatic disease
  • Having cognitive impairment to the extent of not being able to cooperate

Treatment and study plan

Primary outcomes

  1. McGill Melzack Pain Questionnaire

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    McGill Melzack Pain Questionnaire consists of four sections. The total score is between 0 and 78 As the score increases, the pain level worsens.

  2. Pain Catastrophizing Scale for Children

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    Pain Catastrophizing Scale for Children is a revised questionnaire consisting of 13 items. Scores range from 0 to 52. Higher score indicate that worse catastrophizing.

  3. Pain Catastrophizing Scale for Parents

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    It consists of 13 items. The scores range from 0 to 52. Higher score indicate that worse catastrophizing.

  4. Fonseca Anamnestic Questionnaire

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    Temporomandibular joint dysfunction was assessed using the Fonseca Anamnestic Questionnaire. The Fonseca Anamnestic Questionnaire consists of 10 questions. The participant is asked to answer each question as 'Yes' (10 points), 'No' (0 points) and 'Sometimes' (5 points). The questionnaire score is scored for all questions and the severity of Temporomandibular joint dysfunction is classified according to the total score. It is classified as no Temporomandibular joint dysfunction (0-15 points), mild Temporomandibular joint dysfunction (20-40 points), moderate Temporomandibular joint dysfunction (45-65 points), severe Temporomandibular joint dysfunction (70-100).

  5. Demographic and disease-related data

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    Such as forehead pain, jaw pain, sore throat, ear pain, neck pain, shoulder pain, psychiatric support, parental togetherness, parents being involved in the child's life, use of vitamin supplements, history of hospitalization due to headache, previous surgery, hearing problems, recurrent sinus infection, recurrent sore throat, asthma, snoring, snoring during sleep, vomiting with headache, reflux, recurrent stomach pain, numbness and tingling with headache, easy bleeding and bruising, eating disorder, frequent nosebleeds, diabetes, obesity, sudden weight loss were recorded as 'yes/no'.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Investigation of Factors That May Affect Headache in Individuals With Juvenile Onset Systemic Lupus Erythematosus

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 26, 2024
Registry last updated
Apr 27, 2025

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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