Complex Regional Pain Syndrome (CRPS)TARGET PASNCT02800863
TARGET Post-Approval Study
An observational study of Complex Regional Pain Syndrome (CRPS), run by Abbott Medical Devices at 44 sites in United States.
Trial summary
The purpose of this prospective, multicenter, single arm post-approval study is to demonstrate continued safety of the Axium and Proclaim Neurostimulator System for dorsal root ganglion (DRG) stimulation. The primary endpoint is the 12-month serious adverse event rate for permanent implants. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Complex Regional Pain Syndrome (CRPS)
- What is being tested?
- Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System) and Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)
- Type of treatment
- Medical device
- How many people
- 426 participants
- Where
- 44 sitesUnited States
- Study dates
- 23 Aug 2016to 23 Sep 2021
- 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 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects aged 22 to 75 with moderate to severe chronic, intractable, pain of the lower limbs due to CRPS types I and II with a baseline VAS score of 6 or greater.
Who may be able to join
- Subject is male or female between ≥ 22 and ≤ 75 years of age.
- Subject has moderate to severe chronic intractable pain of the lower limbs resulting from Complex Regional Pain Syndrome (CRPS) types I or II.
- Subject has a baseline Visual Analogue Scale (VAS) of ≥ 60 mm for overall pain at the time of the baseline assessment.
- Subject is willing and able to comply with the study requirements.
- Subject is able to provide written informed consent.
Who cannot join
- Subject has an active implantable medical device including but not limited to cardiac pacemakers and cardiac defibrillators.
- Subject is currently involved in medically related litigation, including workers compensation.
- Subject has a life expectancy of less than one year.
- Subject is pregnant or of child bearing potential and not using adequate contraception as determined by the investigator.
- Subject has, or plans to have, a spinal cord stimulation system or infusion pump system implanted.
- Subject has, or plans to have, a peripheral nerve stimulation system (PNS) or peripheral nerve field stimulation system (PNfS) implanted.
- Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the implant procedure and/or recovery from the implant procedure or could complicate the required procedures and evaluations of the study in the judgment of the investigator.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Premier Pain Solutions
Asheville, North Carolina, 28803
Coastal Orthopedics & Sports Medicine Southwest FL
Bradenton, Florida, 34209
Spanish Hills Interventional Pain Specialists
Camarillo, California, 93010
The Spine and Nerve Center of St. Francis
Charleston, West Virginia, 25301
Rush University Medical Center
Chicago, Illinois, 60612
Adena Bone and Joint Center
Chillicothe, Ohio, 45601
The Cleveland Clinic
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27710
Nura
Edina, Minnesota, 55435
Twin Cities Pain Clinic
Edina, Minnesota, 55439
Pacific Sports and Spine
Eugene, Oregon, 97404
Center for Intervetional Pain and Spine
Exton, Pennsylvania, 19341
Front Range Pain Medicine
Fort Collins, Colorado, 80525
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Vertex Spine and Pain
Franklin, Tennessee, 37067
University of Florida - Department of Anesthesia
Gainesville, Florida, 32610
Advanced Pain Management
Greenfield, Wisconsin, 53221
Carolinas Center for Advanced Management of Pain
Greenville, South Carolina, 29615
Advanced Pain Care
Henderson, Nevada, 89052
Goodman Campbell Brain & Spine
Indianapolis, Indiana, 46260
Kansas University Medical Center
Kansas City, Kansas, 66160
Central Texas Pain Institute
Killeen, Texas, 76542
Main Line Spine
King of Prussia, Pennsylvania, 19406
California Orthopedics & Spine
Larkspur, California, 94939
Loma Linda University Hospital
Loma Linda, California, 92354
VA Loma Linda Healthcare System
Loma Linda, California, 92357
Florida Pain Institute
Merritt Island, Florida, 32953
Advanced Pain Solutions
Mesquite, Texas, 75150
Ochsner Medical Center
New Orleans, Louisiana, 70121
Ainsworth Institute of Pain Management
New York, New York, 10022
Better Health Clinical Research
Newnan, Georgia, 30265
Thomas Jefferson Department of Neurosurgery
Philadelphia, Pennsylvania, 19107
Oregon Health & Science University
Portland, Oregon, 97239
Rhode Island Hospital
Providence, Rhode Island, 02903
Nevada Advanced Pain Specialists
Reno, Nevada, 89511
Shannon Clinic
San Angelo, Texas, 76903
University of California - San Francisco
San Francisco, California, 94143
Orthopedic Pain Specialists
Santa Monica, California, 90403
Summit Pain Alliance Inc.
Santa Rosa, California, 95401
Pacific Research Institute
Santa Rosa, California, 95403
Arizona Pain Specialists
Scottsdale, Arizona, 85258
Pain Diagnostics and Interventional Care
Sewickley, Pennsylvania, 15143
The Spine & Pain Institute of New York
Staten Island, New York, 10305
Spinal Diagnostics
Tualatin, Oregon, 97062
About this study
Official title: TARGET: A Post-Approval Study to Evaluate Targeted SCS Spinal Cord Stimulation (SCS) Dorsal Root Ganglion (DRG) Stimulation for the Management of Moderate to Severe Chronic, Intractable, Pain of the Lower Limbs Due to CRPS Types I and II
The purpose of this prospective, multicenter, single arm post-approval study is to demonstrate continued safety of the Axium and Proclaim Neurostimulator System for dorsal root ganglion (DRG) stimulation. The primary endpoint is the 12-month serious adverse event rate for permanent implants.
Read the detailed description
A maximum of 426 adult subjects with moderate to severe chronic, intractable, pain of the lower limbs due to CRPS types I and II will undergo a trial of the Axium or Proclaim Neurostimulator System across up to 45 study sites in the United States. Only subjects who report a 50% or greater reduction in overall pain intensity through direct patient-reported percentage of pain relief will receive the permanent implant. Subjects will then return to the office for follow-up at 1, 3, 6 and 12 months post-permanent implant.
- Conditions
- Complex Regional Pain Syndrome (CRPS)
- Being tested
- Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System), Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)
- Keywords
- Complex Regional Pain Syndrome (CRPS), Chronic pain, SJM-CIP-10113
- Medical subject headings
- Complex Regional Pain Syndromes, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)Device
Electrical stimulation of the DRG using the Axium™ Neurostimulator System
Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)Device
Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.
| Study group | Role | What they receive |
|---|---|---|
| Dorsal Root Ganglion (DRG) Stimulation | Not described Receives: Device: Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System); Device: Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Serious Adverse Events (SAEs)
The serious adverse event rate for subjects receiving the permanent DRG implantable pulse generator (IPG) was analyzed using Kaplan-Meier method on subjects who received the permanent Axium or Proclaim DRG IPG (N = 296). While 426 patients were enrolled, only 296 received the permanent implant. The primary population is 296.
Measured: throughout 12 month study
Secondary outcomes (3)
Percent Change From Baseline to 12 Months Post-permanent Implant for Overall Pain Intensity Measured Using the Visual Analog Scale (VAS)
The VAS is a common, self-administered measure in which subjects rate their pain intensity by marking a vertical line through a 100 mm horizontal line anchored by word descriptors on each end (no pain to worst imaginable pain). The distance between the beginning of the horizontal line and the vertical line is measured to produce a score between 0 and 100 mm (or 0 to 10 cm). A higher score indicates higher pain intensity and a 30% reduction in VAS score from baseline to follow-up is considered clinically relevant.
Measured: 12 months
Change From Baseline to 12 Months Post-permanent Implant for Physical Function Measured Using the Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Physical Function Scale
The PROMIS-29 Profile is an instrument made up of seven individual short forms (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference) that are scored individually. The instrument also includes a single pain intensity item which is reported as its raw score (e.g., 0 to 10). Each item has five response options ranging in value from 1 to 5, except for the Pain Intensity item which has eleven response options ranging in value from 0 to 10. A raw score is created from each short form that makes up the Profile. Raw scores are calculated by summing the values of the response to each question within each domain.
Measured: 12 months
Change From Baseline to 12 Months Post-permanent Implant for Quality of Life Measured Using the PROMIS Global Health Scale
The PROMIS Global Health short form is a validated, 10-item instrument designed to assess multiple health domains. The questionnaire yields a total score and sub-scale scores for Global Physical and Mental Health. Each question has potential five response options ranging in value from one to five to give a total score ranging from 10 to 50. All questions must be answered to arrive at a total score as one or more missing responses will render scores unusable. Scores are converted into t-scores where the average for the general US population is 50 and the SD is 10. Higher scores indicate better global health.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start23 Aug 2016
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
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 Syndrome (CRPS)Studies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ann Jannu, PhD, CCRP, Study director, Abbott Neuromodulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800863
- Sponsor's protocol ID
- SJM-CIP-10113
- Acronym
- TARGET PAS
- Status last verified
- Jan 2024
- First submitted
- 7 Jun 2016
- Last updated
- 8 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TARGET: A Post-Approval Study to Evaluate Targeted SCS Spinal Cord Stimulation (SCS) Dorsal Root Ganglion (DRG) Stimulation for the Management of Moderate to Severe Chronic, Intractable, Pain of the Lower Limbs Due to CRPS Types I and II
- ClinicalTrials.gov ID
- NCT02800863
- Acronym / sponsor ID
- TARGET PAS / SJM-CIP-10113
- Conditions
- Complex Regional Pain Syndrome (CRPS)
- Keywords
- Complex Regional Pain Syndrome (CRPS), Chronic pain, SJM-CIP-10113
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2016 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Posted 8 Jul 2024
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 prospective, multicenter, single arm post-approval study is to demonstrate continued safety of the Axium and Proclaim Neurostimulator System for dorsal root ganglion (DRG) stimulation. The primary endpoint is the 12-month serious adverse event rate for permanent implants.
Detailed description
A maximum of 426 adult subjects with moderate to severe chronic, intractable, pain of the lower limbs due to CRPS types I and II will undergo a trial of the Axium or Proclaim Neurostimulator System across up to 45 study sites in the United States. Only subjects who report a 50% or greater reduction in overall pain intensity through direct patient-reported percentage of pain relief will receive the permanent implant. Subjects will then return to the office for follow-up at 1, 3, 6 and 12 months post-permanent implant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dorsal Root Ganglion (DRG) Stimulation | – | Device: Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System), Device: Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System) |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects aged 22 to 75 with moderate to severe chronic, intractable, pain of the lower limbs due to CRPS types I and II with a baseline VAS score of 6 or greater.
Key inclusion criteria (5 listed)
- Subject is male or female between ≥ 22 and ≤ 75 years of age.
- Subject has moderate to severe chronic intractable pain of the lower limbs resulting from Complex Regional Pain Syndrome (CRPS) types I or II.
- Subject has a baseline Visual Analogue Scale (VAS) of ≥ 60 mm for overall pain at the time of the baseline assessment.
- Subject is willing and able to comply with the study requirements.
- Subject is able to provide written informed consent.
Key exclusion criteria (7 listed)
- Subject has an active implantable medical device including but not limited to cardiac pacemakers and cardiac defibrillators.
- Subject is currently involved in medically related litigation, including workers compensation.
- Subject has a life expectancy of less than one year.
- Subject is pregnant or of child bearing potential and not using adequate contraception as determined by the investigator.
- Subject has, or plans to have, a spinal cord stimulation system or infusion pump system implanted.
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 |
|---|---|---|
| Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)Electrical stimulation of the DRG using the Axium™ Neurostimulator System | Device | Dorsal Root Ganglion (DRG) Stimulation |
| Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System. | Device | Dorsal Root Ganglion (DRG) Stimulation |
Primary outcome
Rate of Serious Adverse Events (SAEs)
Time frame: throughout 12 month study
The serious adverse event rate for subjects receiving the permanent DRG implantable pulse generator (IPG) was analyzed using Kaplan-Meier method on subjects who received the permanent Axium or Proclaim DRG IPG (N = 296). While 426 patients were enrolled, only 296 received the permanent implant. The primary population is 296.
3 secondary outcomes
Percent Change From Baseline to 12 Months Post-permanent Implant for Overall Pain Intensity Measured Using the Visual Analog Scale (VAS)
Time frame: 12 months
Change From Baseline to 12 Months Post-permanent Implant for Physical Function Measured Using the Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Physical Function Scale
Time frame: 12 months
Change From Baseline to 12 Months Post-permanent Implant for Quality of Life Measured Using the PROMIS Global Health Scale
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ann Jannu, PhD, CCRP study director
Abbott Neuromodulation
44 sites 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 (CRPS), run by Abbott Medical Devices at 44 sites 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 5 inclusion and 7 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 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites 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 8 Jul 2024). 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?
Rate of Serious Adverse Events (SAEs) (time frame: throughout 12 month study). 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 8 Jul 2024.