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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Fatigue Syndrome (CFS)

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| adolescents with CFS ( n= 100)<br>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).<br>healthy control subjects with no CFS | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MicroRNAs, Chronic fatigue syndrome, Pain intensity