MicroRNAs as Biomarkers of Pain Intensity in Patients With Chronic Fatigue Syndrome (CFS) (CFs)
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|ClinicalTrials.gov Identifier: NCT03892954|
Recruitment Status : Completed
First Posted : March 27, 2019
Last Update Posted : March 29, 2019
King Saud University
Information provided by (Responsible Party):
Sami Gabr, King Saud University
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.
|Condition or disease|
|Chronic Fatigue Syndrome (CFS)|
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|
|Actual Enrollment :||150 participants|
|Official Title:||MicroRNAs as Biomarkers of Pain Intensity in Patients With Chronic Fatigue Syndrome (CFS)|
|Actual Study Start Date :||April 1, 2016|
|Actual Primary Completion Date :||April 15, 2017|
|Actual Study Completion Date :||April 30, 2017|
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
Primary Outcome Measures :
- Assessment of pain intensity [ Time Frame: 3-4 weeks ]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.
- Assessment of cyclooxygenase 2 protein (COX-2), tumor necrosis factor (TNF-α) and interleukin-6 (IL-6) as physiological pain regulators [ Time Frame: 3-4 weeks ]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
Secondary Outcome Measures :
- Assessment of the levels of Isolated miRNAs in the serum samples. [ Time Frame: 8 weeks ]RT-PCR techniques were used to estimate the levels of mi-RNAs in serum samples of CFS and control subjects
Biospecimen Retention: Samples Without DNA
Blood was collected from all subjects and serum samples were obtained following centrifugation for 1 min. at 1400 rpm, were given a coded study identification number, and were shipped frozen at 20° C for analysis
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