Complex Regional Pain SyndromesNCT06421350
Closed Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome
A study testing Spinal Cord Stimulation Device in people with Complex Regional Pain Syndromes, run by Scripps Health at 1 site in United States.
Trial summary
The primary purpose of this study is to determine the differences in response to treatment of complex regional pain syndrome with a closed-loop spinal cord stimulator if applied in the early phases (acute or subacute) versus the chronic phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Regional Pain Syndromes
- What is being tested?
- Spinal Cord Stimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 18 years or older
- neuromodulation naive patients with unilateral CRPS type 1 or type 2 (defined by Budapest Criteria)
- pre-procedure psychological clearance
Who cannot join
- younger than 18 years
- prior neuromodulation including spinal cord stimulation
- prior dorsal root ganglion stimulation
- prior peripheral nervous system stimulation
- anatomical obstacles to dorsal column lead placement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Scripps Clinic Torrey Pines
La Jolla, California, 92037
Julie C McCauley, 585-554-7122, mccauley.julie@scrippshealth.org
Roslyn M Kackman, 858-554-7122, kackman.roslyn@scrippshealth.org
About this study
Official title: Efficacy of Closed-Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome
The primary purpose of this study is to determine the differences in response to treatment of complex regional pain syndrome with a closed-loop spinal cord stimulator if applied in the early phases (acute or subacute) versus the chronic phase.
Read the detailed description
After being informed about the study and the potential risks, all patients given written informed consent will be organized into group 1 (acute or subacute) and group 2 (chronic). They will undergo a trial period with a temporary spinal cord stimulator for 7 days. After the trial period, if the provider determines the device improved the patient's pain and function, the permanent device will be implanted. The patient will fill out an outcomes packet at baseline, end of trial period, 3 months and 6 months. There will also be a blood draw to evaluate prolactin levels, which are associated with stress and pain, at baseline, end of trial period, and 3 months.
- Conditions
- Complex Regional Pain Syndromes
- Being tested
- Spinal Cord Stimulation Device
- 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.
Spinal Cord Stimulation DeviceDevice
The closed-loop spinal cord stimulation mechanism uses dynamic adjusting stimulation parameters based on real-time physiologic response and is uniquely positioned to mitigate the aberrant inflammatory and neurosensory processing and autonomic dysfunction driving CRPS and its progression between phases.
| Study group | Role | What they receive |
|---|---|---|
| Acute and Subacute Phases of CRPS | Experimental | Participants diagnosed with acute and subacute phases of CRPS will be assigned to this group. Receives: Device: Spinal Cord Stimulation Device |
| Chronic Phase of CRPS | Experimental | Participants diagnosed with chronic CRPS will be assigned to this group. Receives: Device: Spinal Cord Stimulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Complex Regional Pain Syndrome Severity Scores
(CRPS SS) This will be determined at baseline by the provider based on his diagnosis of the patient's condition, being acute and subacute or chronic. This is based on the presence or absence of 16 clinically-assessed signs and symptoms, and complements the diagnostic criteria for CRPS. A higher score indicates greater severity of the condition. This will be followed up at the 7 day trial period, 3 months and 6 months post procedure by evaluation.
Measured: Baseline, 7 day trial period, 3 months, 6 months
Change in Target Activation Amplitude Levels by the Spinal Cord Stimulation Device
Spinal cord stimulation device parameters will be collected to determine if a lower voltage is required to treat acute phase of complex regional pain syndrome as compared to later phases. This will be conducted at follow up visits and analyzed by the medical device representative. The data will be pulled and analyzed to determine the activation point for each patient. This will be captured at the 7 day trial period, 3 months, and 6 months.
Measured: 7 day trial period, 3 months, and 6 months.
Secondary outcomes (10)
Change in Prolactin Levels
We plan to include a physiological marker of pain response by assessing serum prolactin levels, which are linked to dopamine levels in the brain. We will use prolactin as a convenient marker of abnormal dopamine levels due to chronic pain and the response to spinal cord stimulation treatment as an objective quantifiable metric of success with treatment. We will collect this via blood draw at our lab at baseline, at the 7 day trial period, and 3 months.
Measured: Baseline, 7 day trial period, and 3 months
Visual Analogue Pain Scale
(VAS) This will be used to determine the pain intensity the patient is experiencing. It will be on a scale from 0-10, 0 being no pain and 10 being the worst pain.
Measured: Baseline, 7 day trial period, 3 months, and 6 months
Quality of Life Questionnaire
(EQ-5D-5L) Used to capture quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A lower score would indicate a severe score and the patient has a low quality of life. The patient also rates how good or bad their health is on a scale of 0-100, 100 being the best health and 0 being the worst health they could imagine.
Measured: Baseline, 7 day trial period, 3 months, and 6 months
Patient Reported Outcomes Measurement Information System-29 v 2.1
(PROMIS-29v2.1) Used to assess pain intensity using a single 0-10 numeric rating item and seven health domains: physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance.
Measured: Baseline, 7 day trial period, 3 months, and 6 months
General Anxiety Disorder-7
(GAD-7) Used for the screening and severity measuring of generalized anxiety disorder. It consists of seven items the patients rate based on their experiences over the past two weeks. Each item is scored from 0 (none) to 3 (every day). The cumulative score, ranging from 0-21, indicates the severity of GAD symptoms, with higher scores corresponding to greater anxiety levels.
Measured: Baseline, 7 day trial period, 3 months and 6 months.
Patient Health Questionnaire-9
(PHQ-9) Used for screening and measuring the severity of depression. A higher score would indicate the patient has a worse outcome.
Measured: Baseline, 7 day trial period, 3 months, 6 months
Short-Form McGill Pain Questionnaire-2
(SF-MPQ-2) Used to rate the intensity of each type of pain and related symptoms. A higher score means the patient has a worse outcome. They rate their pain and symptoms on a scale of 0-10, with a 0 being no pain and 10 being the worst pain.
Measured: Baseline, 7 day trial period, 3 months, 6 months
Pain Catastrophizing Scale
(PCS) Used to assess catastrophic thinking related to pain among adults with or without chronic pain. A higher score would mean the patient has a worse outcome.
Measured: Baseline, 7 day trial period, 3 months, 6 months
Patient Global Impression of Change
(PGIC) Used to measure the patient's belief about the effectiveness of the treatment. A higher score would reflect the patient believes the treatment is not effective and they have been doing much worse.
Measured: 7 day trial period, 3 months and 6 months
Amount of Pain Medication Consumed by Patient
Used to track amount of pain medication taken by the patient on a daily basis or what they are taking and when they are taking it.
Measured: Baseline, 7 day trial period, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start3 Sep 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain SyndromesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Hiller, MD, Scripps Health
- Investigators
- David B Hiller, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421350
- Sponsor's protocol ID
- 24-8347
- Status last verified
- Oct 2025
- First submitted
- 8 May 2024
- Last updated
- 3 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Closed-Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome
- ClinicalTrials.gov ID
- NCT06421350
- Acronym / sponsor ID
- 24-8347
- Conditions
- Complex Regional Pain Syndromes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 20 May 2024 (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 primary purpose of this study is to determine the differences in response to treatment of complex regional pain syndrome with a closed-loop spinal cord stimulator if applied in the early phases (acute or subacute) versus the chronic phase.
Detailed description
After being informed about the study and the potential risks, all patients given written informed consent will be organized into group 1 (acute or subacute) and group 2 (chronic). They will undergo a trial period with a temporary spinal cord stimulator for 7 days. After the trial period, if the provider determines the device improved the patient's pain and function, the permanent device will be implanted. The patient will fill out an outcomes packet at baseline, end of trial period, 3 months and 6 months. There will also be a blood draw to evaluate prolactin levels, which are associated with stress and pain, at baseline, end of trial period, and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute and Subacute Phases of CRPS | Experimental | Device: Spinal Cord Stimulation DeviceParticipants diagnosed with acute and subacute phases of CRPS will be assigned to this group. |
| Chronic Phase of CRPS | Experimental | Device: Spinal Cord Stimulation DeviceParticipants diagnosed with chronic CRPS will be assigned to this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- neuromodulation naive patients with unilateral CRPS type 1 or type 2 (defined by Budapest Criteria)
- pre-procedure psychological clearance
Key exclusion criteria (5 listed)
- younger than 18 years
- prior neuromodulation including spinal cord stimulation
- prior dorsal root ganglion stimulation
- prior peripheral nervous system stimulation
- anatomical obstacles to dorsal column lead placement
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 Stimulation DeviceThe closed-loop spinal cord stimulation mechanism uses dynamic adjusting stimulation parameters based on real-time physiologic response and is uniquely positioned to mitigate the aberrant inflammatory and neurosensory processing and autonomic dysfunction driving CRPS and its progression between phases. | Device | Acute and Subacute Phases of CRPS, Chronic Phase of CRPS |
Primary outcome
Change in Complex Regional Pain Syndrome Severity Scores
Time frame: Baseline, 7 day trial period, 3 months, 6 months
(CRPS SS) This will be determined at baseline by the provider based on his diagnosis of the patient's condition, being acute and subacute or chronic. This is based on the presence or absence of 16 clinically-assessed signs and symptoms, and complements the diagnostic criteria for CRPS. A higher score indicates greater severity of the condition. This will be followed up at the 7 day trial period, 3 months and 6 months post procedure by evaluation.
Change in Target Activation Amplitude Levels by the Spinal Cord Stimulation Device
Time frame: 7 day trial period, 3 months, and 6 months.
Spinal cord stimulation device parameters will be collected to determine if a lower voltage is required to treat acute phase of complex regional pain syndrome as compared to later phases. This will be conducted at follow up visits and analyzed by the medical device representative. The data will be pulled and analyzed to determine the activation point for each patient. This will be captured at the 7 day trial period, 3 months, and 6 months.
10 secondary outcomes
Change in Prolactin Levels
Time frame: Baseline, 7 day trial period, and 3 months
Visual Analogue Pain Scale
Time frame: Baseline, 7 day trial period, 3 months, and 6 months
Quality of Life Questionnaire
Time frame: Baseline, 7 day trial period, 3 months, and 6 months
Patient Reported Outcomes Measurement Information System-29 v 2.1
Time frame: Baseline, 7 day trial period, 3 months, and 6 months
General Anxiety Disorder-7
Time frame: Baseline, 7 day trial period, 3 months and 6 months.
Patient Health Questionnaire-9
Time frame: Baseline, 7 day trial period, 3 months, 6 months
Short-Form McGill Pain Questionnaire-2
Time frame: Baseline, 7 day trial period, 3 months, 6 months
Pain Catastrophizing Scale
Time frame: Baseline, 7 day trial period, 3 months, 6 months
Patient Global Impression of Change
Time frame: 7 day trial period, 3 months and 6 months
Amount of Pain Medication Consumed by Patient
Time frame: Baseline, 7 day trial period, 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Complex Regional Pain Syndromes
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The Effectiveness of Conservative Treatment in Patients With Complex Regional Pain Syndrome.
CRPS (Complex Regional Pain Syndromes)
RecruitingPhase 3
Phase 3, Open-Label Extension Study of AMBTX-01 (Neridronate) for Complex Regional Pain Syndrome Type 1
Complex Regional Pain Syndrome Type I
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
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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.
David B Hiller, MD principal investigator
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulation Device in people with Complex Regional Pain Syndromes, run by Scripps Health 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie C McCauley (585-554-7122, mccauley.julie@scrippshealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Complex Regional Pain Syndrome Severity Scores (time frame: Baseline, 7 day trial period, 3 months, 6 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 Nov 2025.