Clinical trial NCT03892954: MicroRNAs as Biomarkers of Pain Intensity in Patients With Chronic Fatigue Syndrome (CFS)
Official title: MicroRNAs as Biomarkers of Pain Intensity in Patients With Chronic Fatigue Syndrome (CFS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Fatigue Syndrome (CFS)
Keywords: MicroRNAs
Chronic fatigue syndrome
Pain intensity
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 150 adolescents aged (12-18 years) were invited to participate in this study. Based on CFS diagnosis, participants were classified with CFS (n=100) and healthy controls (n=50). adolescents who had constant or persisting fatigue lasting 3 months with the severe functional disability to such extent that prevents normal school attendance and also had no drug prescriptions (including hormone contraceptives), any medical or psychiatric disorder that might explain the fatigue were included in this study.

Brief summary: MicroRNAs were shown to play an important role in regulating pain-processing in a wide range of experimental models and clinical pain disorders. Thus, the aim of the present study is to evaluate a set of Micro-RNAs as diagnostic biomarkers of pain intensity in adolescents with chronic fatigue syndrome (CFS) and to correlate with inflammatory markers and pain related comorbidities.

Detailed description: The present study was performed to evaluate a set of Micro-RNAs as diagnostic biomarkers of pain intensity in adolescents with chronic fatigue syndrome (CFS) and to correlate with inflammatory markers and pain related comorbidities. Thus, a total of 150 adolescents aged (12-18 years) were invited to participate in this study. They are classified into two groups; adolescents with CFS (n=100) and healthy control (n=50). RT-PCR and immunoassay analysis were used to estimate miRNAs (miR-558, miR-146a, miR-150, miR-124, and miR-143) and immune-inflammatory markers (IL-6, TNF-α, COX-2) respectively.

Eligibility criteria: Inclusion Criteria:

* Participants with CFS who had constant or persisting fatigue lasting 3 months with the severe functional disability to such extent that prevents normal school attendance and also had no drug prescriptions (including hormone contraceptives), any medical or psychiatric disorder that might explain the fatigue were included in this study.

Exclusion Criteria:

* Participants who had drug prescriptions (including hormone contraceptives), any medical or psychiatric disorder that might explain the fatigue were excluded from this study.

Primary outcomes:
measure: Assessment of pain intensity
timeFrame: 3-4 weeks
measure: Assessment of cyclooxygenase 2 protein (COX-2), tumor necrosis factor (TNF-α) and interleukin-6 (IL-6) as physiological pain regulators
timeFrame: 3-4 weeks
Secondary outcomes:
measure: Assessment of the levels of Isolated miRNAs in the serum samples.
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References: