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Trial record 4 of 112 for:    Chronic Fatigue Syndrome

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
Sponsor:
Information provided by (Responsible Party):
Sami Gabr, King Saud University

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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. 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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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

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Responsible Party: Sami Gabr, Principal investigator, King Saud University
ClinicalTrials.gov Identifier: NCT03892954     History of Changes
Other Study ID Numbers: RRC
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sami Gabr, King Saud University:
MicroRNAs
Chronic fatigue syndrome
Pain intensity
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Syndrome
Fatigue
Pain
Disease
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Neurologic Manifestations