Chronic PainAFTSCSCVPNCT00678717
Microneurography and Spinal Cord Stimulation in Chronic Visceral Pain
A study testing Autonomic Evaluation in people with Chronic Pain, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of the spinal cord stimulator (A small wire is surgically implanted under the skin. Low-level electrical signals are then transmitted through the lead to the spinal cord to alleviate pain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Autonomic Evaluation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to 23 Jan 2009
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chronic visceral pain patients candidates for spinal cord stimulation implant with no other chronic diseases.
Who cannot join
- Diabetes, pulmonary or chronic cardiac diseases.
Trial locations and contacts
1 site in 1 country.
United States1 site
Interventional Pain Center
Nashville, Tennessee, 37212
About this study
Official title: Autonomic Function Testing and Spinal Cord Stimulation: Implications for Successful Therapy in Chronic Visceral Pain
The purpose of this study is to assess the effect of the spinal cord stimulator (A small wire is surgically implanted under the skin. Low-level electrical signals are then transmitted through the lead to the spinal cord to alleviate pain. Using a magnetic remote control, the patients can turn the current on and off, or adjust the intensity.) on the autonomic nervous system (sympathetic and parasympathetic). Some studies support that the spinal cord stimulation suppresses or decreases sympathetic outflow (the sympathetic nervous system is the one that provide us with the "flight and fight response" and the parasympathetic nervous system is the one that works while we "sleep, rest and digest".). The sympathetic nervous system is important in blood pressure regulation also. However, there are not reports regarding the effect of the spinal cord stimulation on blood pressure regulation in chronic visceral pain patients. Most clinical trials are focus on the effect of the spinal cord stimulation on pain relief. We think we could use blood pressure, heart rate and special analysis of these signals and their relationship to other pain measurements to assess the effect of the spinal cord stimulation in an objective way.
Read the detailed description
Spinal Cord Stimulation (SCS) has been used since 1967 for the treatment of pain: complex regional pain syndromes 1 , ischemic limb pain 2-5, failed back surgery syndrome 6, 7, and refractory angina pectoris 8-11. Recently, Kapural et al. reported a case series of six patients that underwent SCS for the treatment of chronic visceral pain (CVP)12, 13. SCS reduced 50% of the patients' pain and improved patient functionality by 60% 14 . Animal studies suggested that dorsal column pathways are involved in the transmission of visceral pain 12, 13. Clinical studies in patients with visceral cancer have shown that interruption of the fibers of the dorsal columns that ascend close to the midline of the spinal cord significantly relieves pain and decreases analgesic requirement 15-18. Different studies support the hypothesis that visceral pain perception is positively modulated by the descending pathways from the medulla. Dorsal column lesion leads to a reduction of thalamic activation by visceral stimuli and decreased visceral pain perception 19. Visceral innervation occurs via sympathetic and parasympathetic pathways; parasympathetic afferents enter the vagal afferents carrying nociceptive information enter trunks while sympathetic afferents carrying nociceptive information enter at the levels T6 and L3. Therefore, limited case series using SCS for CVP suggested that pain relief was achieved by blocking these segments suppressing sympathetic outflow to the abdomen and pelvis 14. The relationship between autonomic nervous system (ANS) and pain are poorly understood. Animal and clinical research has provided evidence for close interaction between pain modulatory systems and the ANS 20, 21. However, little is known about the ANS function in chronic pain patients. Our previous funded work suggested that chronic low back pain (CLBP) patients have reduced LFRRI (heart rate variability-low frequency) (not increased as expected) and that indices of the vagal component of the Heart Rate Variability(HRV) (Root Mean Square of the Successive Differences (RMSSD), heart rate variability-high frequency (HFRRI) were also attenuated. The sympatho-vagal balance (LFRRI /HFRRI), a ratio of LF to HF which correlates with higher sympathetic activation 22, was paradoxically increased 23. We previously demonstrated that Low Frequency Systolic Blood Pressure (LFSBP) correlates with muscle sympathetic nerve traffic during orthostatic load supported by a simplified model of blood pressure variability 24. We also showed that LFSBP can be abolished by ganglionic blockade demonstrating the neurogenic origin of these oscillations in blood pressure 25. Additionally, our study revealed decreased baroreflex indices (αHF and BRSLF) during sitting in CLBP patients. Blood pressure was not different in CLBP patients, but there was a trend for higher heart rates possibly caused by higher sympathetic activity to the heart. These findings of reduced baroreflex sensitivity and changes in heart rate support hypothesized alterations in cardio-vagal control in patients with chronic pain 26, 27. In summary, sympathetic function has been assessed by indirect measures. There is no data available regarding the direct assessment of sympathetic outflow in CVP patients. Sympathetic outflow is stimulus specific 28, 29. Therefore, the characterization of resting sympathetic outflow and stimulus-induced sympathetic adjustments requires simultaneous measurements of activity by different techniques. We propose using microneurography to assess the sympathetic function on a second-to-second basis in CVP patients. Microneurography directly assess muscle sympathetic nerve activity (MSNA). This technique is used to define sympathetic responses to a number of standard physiologic maneuvers. It was first developed in Sweden by Wallin, who described the technique for recording afferent muscle or skin sympathetic nerve activity 30, 31. MSNA displays real-time sympathetic nerve activity, allowing definition of sympathetic responses so transient that they would be lost to all other techniques. In general, MSNA burst/min is a good indicator of sympathetic nerve activity 32-37. For example, direct measurement of sympathetic nerve activity as reflected in MSNA has been a very useful tool to demonstrate that increased sympathetic activity is an important factor in the pathogenesis of essential hypertension 38-42. In chronic orthostatic intolerance, a syndrome of autonomic dysfunction in young women MSNA have revealed an abnormal regional distribution of sympathetic activity during orthostatic stress. 43, 44. Moreover, studies in children with complex regional syndrome and adolescents have shown these patients reported systemic ANS symptoms including dizziness, near syncope and postural tachycardia 45-49. Our case series of 5 complex regional pain syndrome patients (4 male, 1 female, 32-51 years) with implanted epidural spinal cord stimulator for pain relief 50 suggested that CRPS (Complex Regional Pain Syndrome) patients have: 1) reduced vasoconstrictor response during Valsalva, 2) A greater blood pressure (BP) drop during straining phase II as compared to normal and less blood pressure overshoot during phase IV in CRPS patients with stimulator turned off and the BP response returns to normal ranges during spinal stimulator turned on. Lastly, muscle sympathetic nerve activity improved during SCS resulting in better blood pressure control. All these data suggest a tight relationship between pain control and sympathetic function. As is well know, CVP is difficult to treat because of its ill-defined nature and treatment with SCS has moderate success, but predicting success in these difficult to treat patients will probably be increased by correlating autonomic function; pain and therapy with spinal cord stimulation.
- Conditions
- Chronic Pain
- Being tested
- Autonomic Evaluation
- Keywords
- abdominal, Pelvic, Pain, SCS, Healthy and Chronic Visceral Pain patients, Chronic Visceral Pain and spinal cord stimulator
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autonomic EvaluationProcedure or surgery
Orthostatic vital signs will be determined by measuring heart rate (HR) and brachial blood pressure (BP) during a tilt table test. The degree of vagal mediated sinus arrhythmia will be assessed during controlled breathing (5 seconds inhalation and 5 seconds exhalation during 90 seconds), and the sinus arrhythmia parameters will be calculated as the difference and ratio of the longest to the shortest RR interval. The sympathetic response during breath hold will be measured. Responses of BP, HR, MSNA will be acquired during Valsalva maneuver. The valsalva ratio of heart rate will be calculated from the maximum of heart rate during or shortly after straining and the minimal depressed heart rate in the overshoot phase IV. Blood pressure and MSNA increase during isometric handgrip maintained at 30% of maximal voluntary contraction for five minutes will be determined. The blood pressure and MSNA response will be measured during cold pressor test with the hand in ice water for 1 minute.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Active comparator | Healthy volunteers Receives: Procedure: Autonomic Evaluation |
| Chronic Visceral Pain | Experimental | Chronic Visceral Pain patients. Participants will be tested before and after implantation of a Spinal Cord Stimulator (implantation of the Spinal Cord Stimulator is done as usual care and is not a study procedure) Receives: Procedure: Autonomic Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle sympathetic nerve activity
Microneurography directly assesses muscle sympathetic nerve activity (MSNA)
Measured: Prior to stimulator implant and within 1 year of receiving stimulator implant
Secondary outcomes (2)
Heart rate
Participants in both arms will be tested at baseline and again within 1 year. Participants in the Chronic Visceral Pain arm will be tested after implantation of a Spinal Cord Stimulator
Measured: Before and up to 1 year after spinal cord stimulator implant
blood pressure
Participants in both arms will be tested at baseline and again within 1 year. Participants in the Chronic Visceral Pain arm will be tested after implantation of a Spinal Cord Stimulator
Measured: Before and up to 1 year after spinal cord stimulator implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startFeb 2008
- Primary completion23 Jan 2009
- Study completion23 Jan 2009
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Konrad, Vanderbilt University Medical Center
- Investigators
- Sukdeb Datta, M.D., Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678717
- Sponsor's protocol ID
- 071179
- Acronym
- AFTSCSCVP
- Status last verified
- Mar 2018
- First submitted
- 8 May 2008
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Function Testing and Spinal Cord Stimulation: Implications for Successful Therapy in Chronic Visceral Pain
- ClinicalTrials.gov ID
- NCT00678717
- Acronym / sponsor ID
- AFTSCSCVP / 071179
- Conditions
- Chronic Pain
- Keywords
- abdominal, Pelvic, Pain, SCS, Healthy and Chronic Visceral Pain patients, Chronic Visceral Pain and spinal cord stimulator
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Feb 2008 (actual)
- Primary completion
- 23 Jan 2009 (actual)
- Study completion
- 23 Jan 2009 (actual)
- First posted
- 15 May 2008 (estimated)
- 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 purpose of this study is to assess the effect of the spinal cord stimulator (A small wire is surgically implanted under the skin. Low-level electrical signals are then transmitted through the lead to the spinal cord to alleviate pain. Using a magnetic remote control, the patients can turn the current on and off, or adjust the intensity.) on the autonomic nervous system (sympathetic and parasympathetic). Some studies support that the spinal cord stimulation suppresses or decreases sympathetic outflow (the sympathetic nervous system is the one that provide us with the "flight and fight response" and the parasympathetic nervous system is the one that works while we "sleep, rest and digest".). The sympathetic nervous system is important in blood pressure regulation also. However, there are not reports regarding the effect of the spinal cord stimulation on blood pressure regulation in chronic visceral pain patients. Most clinical trials are focus on the effect of the spinal cord stimulation on pain relief. We think we could use blood pressure, heart rate and special analysis of these signals and their relationship to other pain measurements to assess the effect of the spinal cord stimulation in an objective way.
Detailed description
Spinal Cord Stimulation (SCS) has been used since 1967 for the treatment of pain: complex regional pain syndromes 1 , ischemic limb pain 2-5, failed back surgery syndrome 6, 7, and refractory angina pectoris 8-11. Recently, Kapural et al. reported a case series of six patients that underwent SCS for the treatment of chronic visceral pain (CVP)12, 13. SCS reduced 50% of the patients' pain and improved patient functionality by 60% 14 . Animal studies suggested that dorsal column pathways are involved in the transmission of visceral pain 12, 13. Clinical studies in patients with visceral cancer have shown that interruption of the fibers of the dorsal columns that ascend close to the midline of the spinal cord significantly relieves pain and decreases analgesic requirement 15-18. Different studies support the hypothesis that visceral pain perception is positively modulated by the descending pathways from the medulla. Dorsal column lesion leads to a reduction of thalamic activation by visceral stimuli and decreased visceral pain perception 19. Visceral innervation occurs via sympathetic and parasympathetic pathways; parasympathetic afferents enter the vagal afferents carrying nociceptive information enter trunks while sympathetic afferents carrying nociceptive information enter at the levels T6 and L3. Therefore, limited case series using SCS for CVP suggested that pain relief was achieved by blocking these segments suppressing sympathetic outflow to the abdomen and pelvis 14. The relationship between autonomic nervous system (ANS) and pain are poorly understood. Animal and clinical research has provided evidence for close interaction between pain modulatory systems and the ANS 20, 21. However, little is known about the ANS function in chronic pain patients. Our previous funded work suggested that chronic low back pain (CLBP) patients have reduced LFRRI (heart rate variability-low frequency) (not increased as expected) and that indices of the vagal component of the Heart Rate Variability(HRV) (Root Mean Square of the Successive Differences (RMSSD), heart rate variability-high frequency (HFRRI) were also attenuated. The sympatho-vagal balance (LFRRI /HFRRI), a ratio of LF to HF which correlates with higher sympathetic activation 22, was paradoxically increased 23. We previously demonstrated that Low Frequency Systolic Blood Pressure (LFSBP) correlates with muscle sympathetic nerve traffic during orthostatic load supported by a simplified model of blood pressure variability 24. We also showed that LFSBP can be abolished by ganglionic blockade demonstrating the neurogenic origin of these oscillations in blood pressure 25. Additionally, our study revealed decreased baroreflex indices (αHF and BRSLF) during sitting in CLBP patients. Blood pressure was not different in CLBP patients, but there was a trend for higher heart rates possibly caused by higher sympathetic activity to the heart. These findings of reduced baroreflex sensitivity and changes in heart rate support hypothesized alterations in cardio-vagal control in patients with chronic pain 26, 27. In summary, sympathetic function has been assessed by indirect measures. There is no data available regarding the direct assessment of sympathetic outflow in CVP patients. Sympathetic outflow is stimulus specific 28, 29. Therefore, the characterization of resting sympathetic outflow and stimulus-induced sympathetic adjustments requires simultaneous measurements of activity by different techniques. We propose using microneurography to assess the sympathetic function on a second-to-second basis in CVP patients. Microneurography directly assess muscle sympathetic nerve activity (MSNA). This technique is used to define sympathetic responses to a number of standard physiologic maneuvers. It was first developed in Sweden by Wallin, who described the technique for recording afferent muscle or skin sympathetic nerve activity 30, 31. MSNA displays real-time sympathetic nerve activity, allowing definition of sympathetic responses so transient that they would be lost to all other techniques. In general, MSNA burst/min is a good indicator of sympathetic nerve activity 32-37. For example, direct measurement of sympathetic nerve activity as reflected in MSNA has been a very useful tool to demonstrate that increased sympathetic activity is an important factor in the pathogenesis of essential hypertension 38-42. In chronic orthostatic intolerance, a syndrome of autonomic dysfunction in young women MSNA have revealed an abnormal regional distribution of sympathetic activity during orthostatic stress. 43, 44. Moreover, studies in children with complex regional syndrome and adolescents have shown these patients reported systemic ANS symptoms including dizziness, near syncope and postural tachycardia 45-49. Our case series of 5 complex regional pain syndrome patients (4 male, 1 female, 32-51 years) with implanted epidural spinal cord stimulator for pain relief 50 suggested that CRPS (Complex Regional Pain Syndrome) patients have: 1) reduced vasoconstrictor response during Valsalva, 2) A greater blood pressure (BP) drop during straining phase II as compared to normal and less blood pressure overshoot during phase IV in CRPS patients with stimulator turned off and the BP response returns to normal ranges during spinal stimulator turned on. Lastly, muscle sympathetic nerve activity improved during SCS resulting in better blood pressure control. All these data suggest a tight relationship between pain control and sympathetic function. As is well know, CVP is difficult to treat because of its ill-defined nature and treatment with SCS has moderate success, but predicting success in these difficult to treat patients will probably be increased by correlating autonomic function; pain and therapy with spinal cord stimulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | Active comparator | Procedure: Autonomic EvaluationHealthy volunteers |
| Chronic Visceral Pain | Experimental | Procedure: Autonomic EvaluationChronic Visceral Pain patients. Participants will be tested before and after implantation of a Spinal Cord Stimulator (implantation of the Spinal Cord Stimulator is done as usual care and is not a study procedure) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic visceral pain patients candidates for spinal cord stimulation implant with no other chronic diseases.
Key exclusion criteria (1 listed)
- Diabetes, pulmonary or chronic cardiac diseases.
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 |
|---|---|---|
| Autonomic EvaluationOrthostatic vital signs will be determined by measuring heart rate (HR) and brachial blood pressure (BP) during a tilt table test. The degree of vagal mediated sinus arrhythmia will be assessed during controlled breathing (5 seconds inhalation and 5 seconds exhalation during 90 seconds), and the sinus arrhythmia parameters will be calculated as the difference and ratio of the longest to the shortest RR interval. The sympathetic response during breath hold will be measured. Responses of BP, HR, MSNA will be acquired during Valsalva maneuver. The valsalva ratio of heart rate will be calculated from the maximum of heart rate during or shortly after straining and the minimal depressed heart rate in the overshoot phase IV. Blood pressure and MSNA increase during isometric handgrip maintained at 30% of maximal voluntary contraction for five minutes will be determined. The blood pressure and MSNA response will be measured during cold pressor test with the hand in ice water for 1 minute. | Procedure or surgery | Chronic Visceral Pain, Healthy |
Primary outcome
Muscle sympathetic nerve activity
Time frame: Prior to stimulator implant and within 1 year of receiving stimulator implant
Microneurography directly assesses muscle sympathetic nerve activity (MSNA)
2 secondary outcomes
Heart rate
Time frame: Before and up to 1 year after spinal cord stimulator implant
blood pressure
Time frame: Before and up to 1 year after spinal cord stimulator implant
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Sukdeb Datta, M.D. principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autonomic Evaluation in people with Chronic Pain, run by Vanderbilt University Medical Center 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: stopped early, as of the sponsor's last update on 16 Mar 2018. 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 was stopped early (reason given: Lack of funding). 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?
Muscle sympathetic nerve activity (time frame: Prior to stimulator implant and within 1 year of receiving stimulator implant). 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 16 Mar 2018.