MicroRNAs as Biomarkers of Pain Intensity in Patients With Chronic Fatigue Syndrome (CFS) (CFs)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Fatigue Syndrome (CFS)

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.

• Study Type: Observational
• Enrollment (Actual): 150

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
adolescents with CFS ( n= 100); 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
health control ( n=50).; healthy control subjects with no CFS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of pain intensity	A pre-validated modified Brief Pain Inventory (BPI) was performed to measure pain scores among both subjects with CFS and healthy controls.The BPI includes four ratings of pain intensity (items 3-7), and seven other ratings on the impact of pain. Intensity is recorded on numerical scales from zero (no pain) to ten (pain as bad as you can imagine). Also, intensity is rated at the time of completing the questionnaires (pain now) as well as its worst, least, and average over the past day or week. The BPI also records the location of the pain on a diagram of a human figure. Patients are also asked to select words that best describe their pain and to indicate the extent and duration of pain relief obtained from analgesics.	3-4 weeks
Assessment of cyclooxygenase 2 protein (COX-2), tumor necrosis factor (TNF-α) and interleukin-6 (IL-6) as physiological pain regulators	For all participants, cyclooxygenase 2 protein (COX-2), tumor necrosis factor (TNF-α) and interleukin-6 (IL-6) were estimated in serum samples of CFS and control subjects	3-4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the levels of Isolated miRNAs in the serum samples.	RT-PCR techniques were used to estimate the levels of mi-RNAs in serum samples of CFS and control subjects	8 weeks

Collaborators and Investigators

• Sponsor: King Saud University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2016
• Primary Completion (ACTUAL): April 15, 2017
• Study Completion (ACTUAL): April 30, 2017

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (ACTUAL): March 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Chronic fatigue syndrome; Pain intensity; MicroRNAs
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Syndrome; Fatigue; Pain; Fatigue Syndrome, Chronic
• Other Study ID Numbers: RRC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No