Spinal Cord StimulationNCT04960592
Epigenetic Mechanisms and Symptom Clusters Associated with Resolution of Pain Following Spinal Cord Stimulation
An observational study of Spinal Cord Stimulation and Chronic Pain, run by University of Arkansas at 1 site in United States.
Trial summary
Spinal cord stimulation (SCS) is indicated for selected patients with chronic pain who have not responded to conventional medical management. Forty (40) patients indicated for SCS placement and presenting to the University of Arkansas for Medical Sciences (UAMS) Interventional Pain Management Clinic in Little Rock… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Stimulation, Chronic Pain
- What is being tested?
- Spinal Cord Stimulation
- Type of treatment
- Medical device
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2021to 1 Jul 2024
- 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 presenting to the UAMS Interventional Pain Management Clinic and Neurosurgery Clinic indicated for a trial neuromodulator device placement. Potentially eligible patients will be identified by health care providers during routine clinic visits. Target enrollment is 100 participants for this study.
Who may be able to join
- Adults (age greater than or equal to18 years) who meet clinical criteria for implantation of a neuromodulation device
- Able to speak, write, and understand English
Who cannot join
- Evidence of monetary gain related to the outcome of the procedure (example worker's compensation, ongoing litigation, pending disability claim)
- Pain greater than 4/10 on pain scale at a bodily site not being treated by the neuromodulation procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Epigenetic Mechanisms and Symptom Clusters Associated with the Resolution of Persistent Pain Following Spinal Cord Stimulation
Spinal cord stimulation (SCS) is indicated for selected patients with chronic pain who have not responded to conventional medical management.
Forty (40) patients indicated for SCS placement and presenting to the University of Arkansas for Medical Sciences (UAMS) Interventional Pain Management Clinic in Little Rock, Arkansas will be recruited for this study. Prior to temporary stimulator placement, patients will complete symptom-related questionnaires and provide a blood sample. Demographic and clinical characteristics will be obtained through medical record review. Patients will complete the same questionnaires and provide a blood sample at each of the routine clinical care follow-up visits.
Read the detailed description
Neuromodulation has emerged as a minimally invasive therapy effective for the treatment of refractory neuropathic pain conditions. Epidural placement of electrodes provides long term analgesia through electrical stimulation of the spinal cord which alters expression of genes involved in synaptic signaling in the dorsal horn. Patients who receive SCS represent a unique opportunity to study the physiological mechanisms associated with the resolution of chronic pain.
This is a descriptive, prospective, longitudinal study that will consist of individuals with persistent pain and meet criteria for implantation of a neurostimulation device. One hundred patients indicated for neurostimulation device placement and presenting to the University of Arkansas for Medical Sciences Interventional Pain Management Clinic in Little Rock, Arkansas will be recruited for this study. Patients who meet study inclusion criteria will be recruited to participate prior to stimulator placement procedure. Following an initial consultation and exam by a physician, patients will have necessary imaging and neuropsychological evaluation. Prior to SCS placement procedure, the patient will complete preoperative labs.
At baseline, patients will be asked to complete the demographic questionnaire, and physical functioning questionnaires, and provide a blood sample. Blood samples will be drawn and stored until sample processing is completed. Medical records will be reviewed and abstracted for research-related data elements from electronic medical records. Questionnaire and form responses are collected and recorded for study use.
Study time points for data collection and sample collection are Baseline (Pre-treatment), routine follow-up visit < 60 days after baseline, 3 months, and 1-year post-implant procedure.
- Conditions
- Spinal Cord Stimulation, Chronic Pain
- Being tested
- Spinal Cord Stimulation
- Keywords
- SCS, Epigenetic, Persistent Pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord StimulationDevice
Temporary implantation of a clinical available neurostimulator.
| Study group | Role | What they receive |
|---|---|---|
| SCS Responders | Patients who receive Spinal Cord Stimulation treatment and experience greater than 50% reduction in pain score following treatment. Receives: Device: Spinal Cord Stimulation | |
| SCS Non Responders | Patients who receive Spinal Cord Stimulation treatment and do not experience greater than 50% reduction in pain score following treatment. Receives: Device: Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genes and regulatory regions associated with the resolution of chronic pain
Identification of genes that are associated with the resolution of pain
Measured: 24 months
Changes in the day to day functioning
Identification of psychosocial measures (i.e., patient reported outcome measures; pain catastrophizing) and patient reported functioning associated with the resolution of pain
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start15 Feb 2021
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord StimulationStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly Stephens, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960592
- Sponsor's protocol ID
- 260886
- Status last verified
- May 2024
- First submitted
- 28 Jun 2021
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The PI will monitor study procedures to protect the safety of research subjects, the quality of the data and the integrity of the study. Results of this study may be used for presentations, posters, or publications. The publications will not contain any identifiable information that could be linked to a participant. The final, anonymized dataset will be made publicly available upon publication of study findings.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Mechanisms and Symptom Clusters Associated with the Resolution of Persistent Pain Following Spinal Cord Stimulation
- ClinicalTrials.gov ID
- NCT04960592
- Acronym / sponsor ID
- 260886
- Conditions
- Spinal Cord Stimulation, Chronic Pain
- Keywords
- SCS, Epigenetic, Persistent Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 14 Jul 2021 (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.
Spinal cord stimulation (SCS) is indicated for selected patients with chronic pain who have not responded to conventional medical management.
Forty (40) patients indicated for SCS placement and presenting to the University of Arkansas for Medical Sciences (UAMS) Interventional Pain Management Clinic in Little Rock, Arkansas will be recruited for this study. Prior to temporary stimulator placement, patients will complete symptom-related questionnaires and provide a blood sample. Demographic and clinical characteristics will be obtained through medical record review. Patients will complete the same questionnaires and provide a blood sample at each of the routine clinical care follow-up visits.
Detailed description
Neuromodulation has emerged as a minimally invasive therapy effective for the treatment of refractory neuropathic pain conditions. Epidural placement of electrodes provides long term analgesia through electrical stimulation of the spinal cord which alters expression of genes involved in synaptic signaling in the dorsal horn. Patients who receive SCS represent a unique opportunity to study the physiological mechanisms associated with the resolution of chronic pain.
This is a descriptive, prospective, longitudinal study that will consist of individuals with persistent pain and meet criteria for implantation of a neurostimulation device. One hundred patients indicated for neurostimulation device placement and presenting to the University of Arkansas for Medical Sciences Interventional Pain Management Clinic in Little Rock, Arkansas will be recruited for this study. Patients who meet study inclusion criteria will be recruited to participate prior to stimulator placement procedure. Following an initial consultation and exam by a physician, patients will have necessary imaging and neuropsychological evaluation. Prior to SCS placement procedure, the patient will complete preoperative labs.
At baseline, patients will be asked to complete the demographic questionnaire, and physical functioning questionnaires, and provide a blood sample. Blood samples will be drawn and stored until sample processing is completed. Medical records will be reviewed and abstracted for research-related data elements from electronic medical records. Questionnaire and form responses are collected and recorded for study use.
Study time points for data collection and sample collection are Baseline (Pre-treatment), routine follow-up visit < 60 days after baseline, 3 months, and 1-year post-implant procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCS Responders | – | Device: Spinal Cord StimulationPatients who receive Spinal Cord Stimulation treatment and experience greater than 50% reduction in pain score following treatment. |
| SCS Non Responders | – | Device: Spinal Cord StimulationPatients who receive Spinal Cord Stimulation treatment and do not experience greater than 50% reduction in pain score following treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the UAMS Interventional Pain Management Clinic and Neurosurgery Clinic indicated for a trial neuromodulator device placement. Potentially eligible patients will be identified by health care providers during routine clinic visits. Target enrollment is 100 participants for this study.
Key inclusion criteria (2 listed)
- Adults (age greater than or equal to18 years) who meet clinical criteria for implantation of a neuromodulation device
- Able to speak, write, and understand English
Key exclusion criteria (2 listed)
- Evidence of monetary gain related to the outcome of the procedure (example worker's compensation, ongoing litigation, pending disability claim)
- Pain greater than 4/10 on pain scale at a bodily site not being treated by the neuromodulation procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Cord StimulationTemporary implantation of a clinical available neurostimulator. | Device | SCS Non Responders, SCS Responders |
Primary outcome
Genes and regulatory regions associated with the resolution of chronic pain
Time frame: 24 months
Identification of genes that are associated with the resolution of pain
Changes in the day to day functioning
Time frame: 24 months
Identification of psychosocial measures (i.e., patient reported outcome measures; pain catastrophizing) and patient reported functioning associated with the resolution of pain
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 3 Sep 2024.
- Individual participant dataSharing planned: No. The PI will monitor study procedures to protect the safety of research subjects, the quality of the data and the integrity of the study. Results of this study may be used for presentations, posters, or publications. The publications will not contain any identifiable information that could be linked to a participant. The final, anonymized dataset will be made publicly available upon publication of study findings.
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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.
Kimberly Stephens, PhD principal investigator
University of Arkansas
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 Spinal Cord Stimulation and Chronic Pain, run by University of Arkansas 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 2 inclusion and 2 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 3 Sep 2024. 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?
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?
Genes and regulatory regions associated with the resolution of chronic pain (time frame: 24 months). 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 3 Sep 2024.