FibromyalgiaNCT03495245
Identification of Potential Biomarkers for Pain
An observational study of Fibromyalgia, run by Rowan University at 1 site in United States.
Trial summary
The study investigates the potential of using serum biomarkers to assess pain in fibromyalgia patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2018to 30 Sep 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that are seen at the NeuroMusculoskeletal Institute at Rowan University School of Osteopathic Medicine.
Who may be able to join
- Diagnosed with Fibromyalgia
Who cannot join
- Evidence of a history of substance abuse, neurological or oncologic disease, ischemic heart disease, kidney or hepatic insufficiency.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rowan University School of Osteopathic Medicine
Stratford, New Jersey, 08084
About this study
Official title: Development of a Serum Biomarker-Based Approach to Monitor Opioid Adherence and Minimize Substance Misuse in Chronic Pain Management
The study investigates the potential of using serum biomarkers to assess pain in fibromyalgia patients.
Read the detailed description
At the heart of the opioid epidemic is the lack of an objective measure of pain, which will help evaluate the validity of the patients' perception that the current dosage of opioid is sufficient of insufficient to alleviate pain. This study will test the quantifiable proteins such as S100B and BDNF will serve as objective measures (biomarkers) of pain.
Fibromyalgia patients will be recruited into two groups-- one that uses opioids and the other that does not. Blood will be collected every 6 months for two years. The serum will be used to assay for levels of S100B and BDNF, The pressure-pain threshold (PPT) data, as part of standard of care, will also be collected. Correlation will the be assessed.
- Conditions
- Fibromyalgia
- Keywords
- pain, opioid, fibromyalgia
- Medical subject headings
- Fibromyalgia, 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 |
|---|---|---|
| Opioid Usage | Patients that are currently diagnosed with fibromyalgia and taking opioids. | |
| No Opioid Usage | Patients that are currently diagnosed with fibromyalgia and are not taking opioids. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum protein levels as a marker for pain
Serum proteins will be assayed from patients. The correlation between the serum levels and the visual analog pain scale will be determined.
0 on the visual analog pain scale represents that their is no pain. 10 on the visual analog pain scale represents severe pain.
Measured: 2-4 years
Secondary outcomes (2)
Determine if correlation may be established between impact of fibromyalgia and opioid doses
The prescribed opioid doses, if effective, will be expected to reduce/maintain the scores from the Revised Fibromyalgia Impact Questionnaire. Correlations will be determined through established statistical methods.
The results from the FIQR can estimate the fibromyalgia severity and impact.
Measured: 2-4 years
Determine if correlation may be established between sleep index and opioid doses
The prescribed opioid doses, if effective, will be expected to reduce/maintain the scores from the Sleep Questionnaire. Correlations will be determined through established statistical methods.
This questionnaire can help determine the overall quality of person's sleep.
Measured: 2-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start28 Mar 2018
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rowan University
- Sponsor type
- University, hospital or other
- Collaborators
- American Osteopathic Association
- Responsible party
- Principal investigator, Venkat Venkataraman, PhD, Rowan University
- Investigators
- Venkateswar Venkataraman, PhD, Principal investigator, Rowan University School of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495245
- Sponsor's protocol ID
- Pro2017001740
- Status last verified
- Nov 2019
- First submitted
- 18 Jan 2018
- Last updated
- 19 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Serum Biomarker-Based Approach to Monitor Opioid Adherence and Minimize Substance Misuse in Chronic Pain Management
- ClinicalTrials.gov ID
- NCT03495245
- Acronym / sponsor ID
- Pro2017001740
- Conditions
- Fibromyalgia
- Keywords
- pain, opioid, fibromyalgia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rowan UniversityUniversity, hospital or other
- Collaborators
- American Osteopathic Association
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 11 Apr 2018 (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.
The study investigates the potential of using serum biomarkers to assess pain in fibromyalgia patients.
Detailed description
At the heart of the opioid epidemic is the lack of an objective measure of pain, which will help evaluate the validity of the patients' perception that the current dosage of opioid is sufficient of insufficient to alleviate pain. This study will test the quantifiable proteins such as S100B and BDNF will serve as objective measures (biomarkers) of pain.
Fibromyalgia patients will be recruited into two groups-- one that uses opioids and the other that does not. Blood will be collected every 6 months for two years. The serum will be used to assay for levels of S100B and BDNF, The pressure-pain threshold (PPT) data, as part of standard of care, will also be collected. Correlation will the be assessed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid Usage | – | –Patients that are currently diagnosed with fibromyalgia and taking opioids. |
| No Opioid Usage | – | –Patients that are currently diagnosed with fibromyalgia and are not taking opioids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that are seen at the NeuroMusculoskeletal Institute at Rowan University School of Osteopathic Medicine.
Key inclusion criteria (1 listed)
- Diagnosed with Fibromyalgia
Key exclusion criteria (1 listed)
- Evidence of a history of substance abuse, neurological or oncologic disease, ischemic heart disease, kidney or hepatic insufficiency.
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
Serum protein levels as a marker for pain
Time frame: 2-4 years
Serum proteins will be assayed from patients. The correlation between the serum levels and the visual analog pain scale will be determined. 0 on the visual analog pain scale represents that their is no pain. 10 on the visual analog pain scale represents severe pain.
2 secondary outcomes
Determine if correlation may be established between impact of fibromyalgia and opioid doses
Time frame: 2-4 years
Determine if correlation may be established between sleep index and opioid doses
Time frame: 2-4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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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.
Venkateswar Venkataraman, PhD principal investigator
Rowan University School of Osteopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Rowan University at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Serum protein levels as a marker for pain (time frame: 2-4 years). 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 19 Nov 2019.