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

NCT03892954 | Completed

• 1 other identifier: RRC
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Fatigue Syndrome (CFS)

Keywords

MicroRNAs; Chronic fatigue syndrome; Pain intensity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Assessment of the levels of Isolated miRNAs in the serum samples.

  8 weeks

Study Arms (2)

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

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• King Saud University: lead

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

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 27, 2019
• Study Start: April 1, 2016
• Primary Completion: April 15, 2017
• Study Completion: April 30, 2017
• Last Updated: March 29, 2019

Record last verified: 2019-03