Complex Regional Pain SyndromeNCT03794024
Comparison of Dorsal Column Stimulation to Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome
An observational study of Complex Regional Pain Syndrome, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Complex Regional Pain Syndrome (CRPS) is a constellation of pain symptoms which are associated with impairment in mood, social and physical function. Spinal Cord Stimulation (SCS), a technique of placing electrodes into the epidural space is a validated treatment for Complex Regional Pain Syndrome . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Regional Pain Syndrome
- What is being tested?
- The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator and The Axium Neurostimulator System
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2019to 31 Mar 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult, Older adult
Study population: Patients with Budapest criteria (research diagnostic definition) of Complex Regional Pain Syndrome occurring below the umbilicus who have not had an adequate response to conservative management including analgesic and physical therapies.
Who may be able to join
- • Patient is greater than18 years of age
- An infraumbilical location of the index pain
- Symptoms have been present for greater than 6 months
- Continuing pain which is disproportionate to any inciting event
- Report hyperesthesia and/or allodynia
- Report vasomotor changes including temperature asymmetry and/or skin color changes and/or skin color asymmetry
Show all 18Show fewer
- Report edema and/or sweating changes and/or sweating asymmetry
- Report decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin)
- Display at least one sign in two or more of the following categories:
- Sensory: Evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch and/or temperature sensation and/or deep somatic pressure and/or joint movement)
- Vasomotor: Evidence of temperature asymmetry (>1°C) and/or skin color changes and/or asymmetry
- Sudomotor/Edema: Evidence of edema and/or sweating changes and/or sweating asymmetry
- Motor/Trophic: Evidence of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin)
- Patient failed to have resolution of symptoms despite at least 4 weeks of conservative management including analgesic pharmacotherapy and physical therapy
- Patient has index site pain > spine pain
- The subject is physically and mentally able to participate in the study
- Patient is willing and able to provide informed consent
- Patient is willing and able to comply with the study protocol
Who cannot join
- Previous surgery to the spine which could compromise placement of the study device
- Anatomical spinal abnormality including severe central canal stenosis or bony foraminal impingement which could preclude device placement
- Foreseen need for MRI to monitor or evaluate another chronic condition
- Previous experience with an implanted or trial neuromodulation system (spinal cord stimulation, peripheral nerve stimulation) for the treatment of pain at the index location
- Active local or systemic infection
- Actively in litigation for pain symptoms
- Currently on Workman's Compensation
- Women who are pregnant or intend to become pregnant during the study duration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Center, Randomized Prospective Comparative Effectiveness Study of Dorsal Column Spinal Cord Stimulation to Dorsal Root Ganglion Stimulation in the Treatment of Complex Regional Pain Syndrome
Complex Regional Pain Syndrome (CRPS) is a constellation of pain symptoms which are associated with impairment in mood, social and physical function. Spinal Cord Stimulation (SCS), a technique of placing electrodes into the epidural space is a validated treatment for Complex Regional Pain Syndrome . Treatment of CRPS with SCS, in combination with physical therapy, reduced pain to a greater degree than physical therapy alone. 40%-50% of CRPS patients achieve >50% pain relief with SCS using dorsal column stimulation . Dorsal Root Ganglion (DRG) SCS has also recently demonstrated clinical efficacy in patients with CRPS and peripheral causalgia . The hypothesis is that DRG stimulation is non-inferior to dorsal column SCS in patients with CRPS who have failed to respond to a course of analgesics and physical therapy. The aim to assess functional, quality of life, patient satisfaction and medication requirements in subjects treated with neuromodulation for CRPS and contrast outcomes amongst subjects treated with DRG SCS and dorsal column SCS.
Read the detailed description
The purpose of this study is to compare outcomes between dorsal column spinal cord stimulation and dorsal root ganglion spinal cord stimulation in patients with Complex Regional Pain Syndrome at an infraumbilical location who have failed a course of conservative management including analgesic pharmacotherapy and physical therapy.
This is a prospective randomized post-marketing clinical study. Patients will be randomized in a 1:1 ratio to Dorsal Column or Dorsal Root Ganglion Spinal Cord Stimulation if they have failed a course of conservative management including analgesics and physical therapy. All patients are expected to undergo clinical, neurological, and imaging assessments, if appropriate, at selected follow-up visits.
The study will be conducted a single center with a target maximum of 62 patients (31 randomized to each group).
Enrollment of subjects in this study is anticipated to take 24 months. Clinical follow-up evaluations will be conducted at 10 days, 1, 3 and 6 months post-implant. The total study duration is expected to be at least 30 months.
All patients presenting to the Investigators with Budapest criteria, research subset , for the diagnosis of Complex Regional Pain Syndrome at an infraumbilical location who have not had an adequate response to a course of conservative management including analgesics and physical therapy will be screened for eligibility. A Screening/Enrollment Log will be utilized in order to maintain a cumulative tracking of all screened patients.
Patients must meet all inclusion/exclusion criteria for enrollment in the clinical study. Reasons for screening failure(s) will be documented.
- Conditions
- Complex Regional Pain Syndrome
- Being tested
- The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator, The Axium Neurostimulator System
- 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.
The Nuvectra Algovita Dorsal Column Spinal Cord StimulatorDevice
The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
The Axium Neurostimulator SystemDevice
The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II
| Study group | Role | What they receive |
|---|---|---|
| Dorsal Column Stimulation | Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator Receives: Device: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator | |
| Dorsal Root Ganglion Stimulation | Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System Receives: Device: The Axium Neurostimulator System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numerical Rating Scale for Pain Intensity
To compare the outcomes of dorsal column stimulation with Dorsal Root Ganglion stimulation in patients with Complex Regional Pain Syndrome that persist despite a course of conservative management including physical therapy and analgesic pharmacotherapy using an 11-point [0-10] Numerical Rating Scale (NRS) for Pain Intensity at 6 months. A score of zero indicates no pain, and 10 indicates the worst possible pain imaginable.
Measured: 6 Months
Secondary outcomes (1)
Change in Oswestry Disability Index for Pain Intensity
To compare the outcomes of dorsal column stimulation with Dorsal Root Ganglion stimulation in patients with Complex Regional Pain Syndrome that persist despite a course of conservative management including physical therapy and analgesic pharmacotherapy in function based on Oswestry Disability Index (ODI) for functional impairment. A score of 0 on the 101-point [0-100] Oswestry Disability Index indicates no disability while 100 indicates bed-bound.
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start8 Jan 2019
- Primary completion3 Mar 2020
- Study completion31 Mar 2020
Why it stopped: Manufacturer of the device filed for bankruptcy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Complex Regional Pain SyndromeStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Bolash, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794024
- Sponsor's protocol ID
- 18-1115
- Status last verified
- Feb 2023
- First submitted
- 31 Dec 2018
- Last updated
- 27 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Randomized Prospective Comparative Effectiveness Study of Dorsal Column Spinal Cord Stimulation to Dorsal Root Ganglion Stimulation in the Treatment of Complex Regional Pain Syndrome
- ClinicalTrials.gov ID
- NCT03794024
- Acronym / sponsor ID
- 18-1115
- Conditions
- Complex Regional Pain Syndrome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Manufacturer of the device filed for bankruptcy
- Enrolment
- 1 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 4 Jan 2019 (actual)
- Results
- Posted 24 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Complex Regional Pain Syndrome (CRPS) is a constellation of pain symptoms which are associated with impairment in mood, social and physical function. Spinal Cord Stimulation (SCS), a technique of placing electrodes into the epidural space is a validated treatment for Complex Regional Pain Syndrome . Treatment of CRPS with SCS, in combination with physical therapy, reduced pain to a greater degree than physical therapy alone. 40%-50% of CRPS patients achieve >50% pain relief with SCS using dorsal column stimulation . Dorsal Root Ganglion (DRG) SCS has also recently demonstrated clinical efficacy in patients with CRPS and peripheral causalgia . The hypothesis is that DRG stimulation is non-inferior to dorsal column SCS in patients with CRPS who have failed to respond to a course of analgesics and physical therapy. The aim to assess functional, quality of life, patient satisfaction and medication requirements in subjects treated with neuromodulation for CRPS and contrast outcomes amongst subjects treated with DRG SCS and dorsal column SCS.
Detailed description
The purpose of this study is to compare outcomes between dorsal column spinal cord stimulation and dorsal root ganglion spinal cord stimulation in patients with Complex Regional Pain Syndrome at an infraumbilical location who have failed a course of conservative management including analgesic pharmacotherapy and physical therapy.
This is a prospective randomized post-marketing clinical study. Patients will be randomized in a 1:1 ratio to Dorsal Column or Dorsal Root Ganglion Spinal Cord Stimulation if they have failed a course of conservative management including analgesics and physical therapy. All patients are expected to undergo clinical, neurological, and imaging assessments, if appropriate, at selected follow-up visits.
The study will be conducted a single center with a target maximum of 62 patients (31 randomized to each group).
Enrollment of subjects in this study is anticipated to take 24 months. Clinical follow-up evaluations will be conducted at 10 days, 1, 3 and 6 months post-implant. The total study duration is expected to be at least 30 months.
All patients presenting to the Investigators with Budapest criteria, research subset , for the diagnosis of Complex Regional Pain Syndrome at an infraumbilical location who have not had an adequate response to a course of conservative management including analgesics and physical therapy will be screened for eligibility. A Screening/Enrollment Log will be utilized in order to maintain a cumulative tracking of all screened patients.
Patients must meet all inclusion/exclusion criteria for enrollment in the clinical study. Reasons for screening failure(s) will be documented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dorsal Column Stimulation | – | Device: The Nuvectra Algovita Dorsal Column Spinal Cord StimulatorSubjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator |
| Dorsal Root Ganglion Stimulation | – | Device: The Axium Neurostimulator SystemSubjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with Budapest criteria (research diagnostic definition) of Complex Regional Pain Syndrome occurring below the umbilicus who have not had an adequate response to conservative management including analgesic and physical therapies.
Key inclusion criteria (18 listed)
- • Patient is greater than18 years of age
Key exclusion criteria (8 listed)
- Previous surgery to the spine which could compromise placement of the study device
- Anatomical spinal abnormality including severe central canal stenosis or bony foraminal impingement which could preclude device placement
- Foreseen need for MRI to monitor or evaluate another chronic condition
- Previous experience with an implanted or trial neuromodulation system (spinal cord stimulation, peripheral nerve stimulation) for the treatment of pain at the index location
- Active local or systemic infection
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 |
|---|---|---|
| The Nuvectra Algovita Dorsal Column Spinal Cord StimulatorThe Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. | Device | Dorsal Column Stimulation |
| The Axium Neurostimulator SystemThe Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II | Device | Dorsal Root Ganglion Stimulation |
Primary outcome
Change in Numerical Rating Scale for Pain Intensity
Time frame: 6 Months
To compare the outcomes of dorsal column stimulation with Dorsal Root Ganglion stimulation in patients with Complex Regional Pain Syndrome that persist despite a course of conservative management including physical therapy and analgesic pharmacotherapy using an 11-point [0-10] Numerical Rating Scale (NRS) for Pain Intensity at 6 months. A score of zero indicates no pain, and 10 indicates the worst possible pain imaginable.
1 secondary outcome
Change in Oswestry Disability Index for Pain Intensity
Time frame: 6 Month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Complex Regional Pain Syndrome
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Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
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RecruitingPhase 3
Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Complex Regional Pain Syndrome Type I
Recruiting
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
Chronic Neuropathic Pain, Post-Stroke Pain
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.
Robert Bolash, MD principal investigator
The Cleveland Clinic
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 Complex Regional Pain Syndrome, run by The Cleveland Clinic 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 18 inclusion and 8 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 Feb 2023. 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?
Yes. Results are posted in the registry (first posted 24 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Numerical Rating Scale for Pain Intensity (time frame: 6 Months). 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 Feb 2023.