Chronic Fatigue Syndrome (CFS)CFsNCT03892954
MicroRNAs as Biomarkers of Pain Intensity in Patients With Chronic Fatigue Syndrome (CFS)
An observational study of Chronic Fatigue Syndrome (CFS), run by King Saud University.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome (CFS)
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 30 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Participants who had drug prescriptions (including hormone contraceptives), any medical or psychiatric disorder that might explain the fatigue were excluded from this study.
About this study
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.
Read the 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.
- Conditions
- Chronic Fatigue Syndrome (CFS)
- Keywords
- MicroRNAs, Chronic fatigue syndrome, Pain intensity
- Medical subject headings
- Fatigue Syndrome, Chronic, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3-4 weeks
Secondary outcomes (1)
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Apr 2016
- Primary completion15 Apr 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue Syndrome (CFS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sami Gabr, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892954
- Sponsor's protocol ID
- RRC
- Acronym
- CFs
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroRNAs as Biomarkers of Pain Intensity in Patients With Chronic Fatigue Syndrome (CFS)
- ClinicalTrials.gov ID
- NCT03892954
- Acronym / sponsor ID
- CFs / RRC
- Conditions
- Chronic Fatigue Syndrome (CFS)
- Keywords
- MicroRNAs, Chronic fatigue syndrome, Pain intensity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 15 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants who had drug prescriptions (including hormone contraceptives), any medical or psychiatric disorder that might explain the fatigue were excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Assessment of the levels of Isolated miRNAs in the serum samples.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Fatigue Syndrome (CFS), run by King Saud University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain intensity (time frame: 3-4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.