Complex Regional Pain SyndromeCRPSNCT00780390
Autonomic Dysfunction and Spinal Cord Stimulation in Complex Regional Pain Syndrome
A study testing Autonomic Function Assessment in people with Complex Regional Pain Syndrome, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
To demonstrate that spinal cord stimulator has an effect on sympathetic function (the one that give us the fight and flight response). Therefore, if the spinal cord stimulator has an effect on sympathetic function, the responses from CRPS patients to different stimuli will differ significantly pre and post SCS… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Complex Regional Pain Syndrome
- What is being tested?
- Autonomic Function Assessment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jan 2010
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CRPS patients meeting the inclusion criteria according to the International Association for the Study of pain task Force will be included in the study.
- Age: 18 to 65.
- Disease duration of at least 6 months.
- History of unsuccessful long lasting therapies: physical therapy, transcutaneous electrical stimulation and medication.
Who cannot join
- Presence of current or past pulmonary, hepatic, renal disease, arthritis, hematopoietic, and neurological diseases not related to CRPS.
- Anticoagulant therapy, cardiac pacemaker used.
- Pregnancy test for females is positive.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autonomic Dysfunction and Spinal Cord Stimulator in Complex Regional Pain Syndrome
To demonstrate that spinal cord stimulator has an effect on sympathetic function (the one that give us the fight and flight response). Therefore, if the spinal cord stimulator has an effect on sympathetic function, the responses from CRPS patients to different stimuli will differ significantly pre and post SCS implant.
If CRPS patients exhibit autonomic, CRPS patients could be stratified according to their sympathetic function pre-implant. It is expected that patients with a moderate/mild form of autonomic dysfunction will have better outcomes with the SCS.
Read the detailed description
Currently the mechanisms of Complex Regional Pain Syndrome (CRPS) are poorly understood and stratification of either diagnosis or therapy is very weak. . There is a great need to develop and validate more objective methods to characterize and stratify CRPS that better diagnostic and therapeutic approaches are available. Spinal Cord Stimulation (SCS) has been used as the last resource to alleviate pain and re-establish function in CRPS patients. However, there is a disagreement over how it works. An underlying concept is that it works by modulating autonomic nervous system (ANS) activity. Therefore, ANS parameters could be useful to stratify patients. Our preliminary studies indicated that SCS has also an effect on blood pressure regulation and improves the CRPS patients' response to Valsalva maneuver -a test of autonomic function. The Autonomic Nervous System function in adult CRPS patients has not yet been studied. The only existing study of CRPS and autonomic function showed that 15% of the patients suffer from syncope and increased heart rate during upright position similar to same aged patients with postural tachycardia syndrome - a syndrome of autonomic dysfunction. It is unclear if autonomic dysfunction is present in CRPS patients because ANS activity is altered by chronic pain or whether or not ANS activity contributes to CRPS. Therefore, we proposed to study the autonomic function in CRPS patients by standardized autonomic function and to evaluate the effect of the SCS on autonomic function in CRPS patients before and after spinal cord stimulator implant. This is a 24 months study.
- Conditions
- Complex Regional Pain Syndrome
- Being tested
- Autonomic Function Assessment
- Keywords
- RSD, SCS, CRPS
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autonomic Function AssessmentOther
| Study group | Role | What they receive |
|---|---|---|
| CRPS patients without spinal cord stimulation | Placebo comparator | CRPS patients declining spinal cord stimulation therapy. Autonomic Function will be assessed at baseline and again within 2 years. Receives: Other: Autonomic Function Assessment |
| CRPS patients: candidates for spinal cord stimulator | Experimental | CRPS patients who are candidates for spinal cord stimulator implant. These patients will have Autonomic Function assessments before and after the Standard of Care spinal cord stimulation implant Receives: Other: Autonomic Function Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle sympathetic nerve activity
Electrical neurography data from sympathetic nerves
Measured: At baseline and within 2 years
Secondary outcomes (2)
Heart rate
Heart rate (bpm)
Measured: At baseline and within 2 years
Blood pressure response
Blood pressure (mmHg)
Measured: At baseline and within 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: Lack of enrollment and discontinued funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain SyndromeStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 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
- Peter Konrad, M.D., Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780390
- Sponsor's protocol ID
- 071060
- Acronym
- CRPS
- Status last verified
- Jul 2026
- First submitted
- 8 May 2008
- Last updated
- 27 Jul 2026
- 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 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Dysfunction and Spinal Cord Stimulator in Complex Regional Pain Syndrome
- ClinicalTrials.gov ID
- NCT00780390
- Acronym / sponsor ID
- CRPS / 071060
- Conditions
- Complex Regional Pain Syndrome
- Keywords
- RSD, SCS, CRPS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment and discontinued funding
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 27 Oct 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.
To demonstrate that spinal cord stimulator has an effect on sympathetic function (the one that give us the fight and flight response). Therefore, if the spinal cord stimulator has an effect on sympathetic function, the responses from CRPS patients to different stimuli will differ significantly pre and post SCS implant.
If CRPS patients exhibit autonomic, CRPS patients could be stratified according to their sympathetic function pre-implant. It is expected that patients with a moderate/mild form of autonomic dysfunction will have better outcomes with the SCS.
Detailed description
Currently the mechanisms of Complex Regional Pain Syndrome (CRPS) are poorly understood and stratification of either diagnosis or therapy is very weak. . There is a great need to develop and validate more objective methods to characterize and stratify CRPS that better diagnostic and therapeutic approaches are available. Spinal Cord Stimulation (SCS) has been used as the last resource to alleviate pain and re-establish function in CRPS patients. However, there is a disagreement over how it works. An underlying concept is that it works by modulating autonomic nervous system (ANS) activity. Therefore, ANS parameters could be useful to stratify patients. Our preliminary studies indicated that SCS has also an effect on blood pressure regulation and improves the CRPS patients' response to Valsalva maneuver -a test of autonomic function. The Autonomic Nervous System function in adult CRPS patients has not yet been studied. The only existing study of CRPS and autonomic function showed that 15% of the patients suffer from syncope and increased heart rate during upright position similar to same aged patients with postural tachycardia syndrome - a syndrome of autonomic dysfunction. It is unclear if autonomic dysfunction is present in CRPS patients because ANS activity is altered by chronic pain or whether or not ANS activity contributes to CRPS. Therefore, we proposed to study the autonomic function in CRPS patients by standardized autonomic function and to evaluate the effect of the SCS on autonomic function in CRPS patients before and after spinal cord stimulator implant. This is a 24 months study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRPS patients without spinal cord stimulation | Placebo comparator | Other: Autonomic Function AssessmentCRPS patients declining spinal cord stimulation therapy. Autonomic Function will be assessed at baseline and again within 2 years. |
| CRPS patients: candidates for spinal cord stimulator | Experimental | Other: Autonomic Function AssessmentCRPS patients who are candidates for spinal cord stimulator implant. These patients will have Autonomic Function assessments before and after the Standard of Care spinal cord stimulation implant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CRPS patients meeting the inclusion criteria according to the International Association for the Study of pain task Force will be included in the study.
- Age: 18 to 65.
- Disease duration of at least 6 months.
- History of unsuccessful long lasting therapies: physical therapy, transcutaneous electrical stimulation and medication.
Key exclusion criteria (3 listed)
- Presence of current or past pulmonary, hepatic, renal disease, arthritis, hematopoietic, and neurological diseases not related to CRPS.
- Anticoagulant therapy, cardiac pacemaker used.
- Pregnancy test for females is positive.
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 Function Assessment | Other | CRPS patients without spinal cord stimulation, CRPS patients: candidates for spinal cord stimulator |
Primary outcome
Change in muscle sympathetic nerve activity
Time frame: At baseline and within 2 years
Electrical neurography data from sympathetic nerves
2 secondary outcomes
Heart rate
Time frame: At baseline and within 2 years
Blood pressure response
Time frame: At baseline and within 2 years
Results and safety
The study was stopped early (reason given: Lack of enrollment and discontinued funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
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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.
Peter Konrad, 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 Function Assessment in people with Complex Regional Pain Syndrome, 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 4 inclusion and 3 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 27 Jul 2026. 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. Some participants in this study may receive a placebo. 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 enrollment and discontinued 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?
Change in muscle sympathetic nerve activity (time frame: At baseline and within 2 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 27 Jul 2026.