An observational study in Complex Regional Pain Syndrome (CRPS), sponsored by Abbott Medical Devices. Completed at 44 sites in United States. Open to participants aged 22 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by Abbott Medical Devices (part of Abbott) · Observational
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Among 88 studies in Complex Regional Pain Syndromes with a site in United States — 20 open to participants now, 22 under way, 2 of them phase 3. Complex Regional Pain Syndromes · United States.
Among the 88 studies in Complex Regional Pain Syndromes with a site in United States, this one has the largest enrollment of the 21 observational ones that give a count, is one of 6 that started in 2016, is one of 21 observational ones, and was the 40th registered.
206 studies on the registry are indexed under Complex Regional Pain Syndromes; 54 are open to participants now.
Browse Complex Regional Pain Syndromes studies →20 of the 88 studies in Complex Regional Pain Syndromes with a site in United States are open now. Recruiting first, the newest first:
Ambros Therapeutics, Inc. · Sites in United States
Ages 18+
The Cleveland Clinic · Sites in United States
Ages 18+
Ambros Therapeutics, Inc. · Sites in United States
Ages 18+
Ambros Therapeutics, Inc. · Sites in United States
Ages 18+
Scripps Health · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 39 Complex Regional Pain Syndromes studies recruiting now, 17 (44%) set no upper age limit and 16 (41%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.
This study: 22 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
88 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 10 · Phase 3 13 · Phase 4 4
First in 2000; this study’s year is marked. 6 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 426 is above the median of 58 across 44 observational studies indexed under Complex Regional Pain Syndromes.
Median enrollment 30 across the 67 interventional studies, 60 across the 21 observational. Of the 56 that completed or were terminated, 29 (52%) have results posted.
This tab as a report to print or save as PDF → With an account.
20 of 88 have an industry lead sponsor. The 10 most frequent:
This study is registered under Abbott Medical Devices, one of the names counted as Abbott. Under that name alone:
Abbott Medical Devices is the lead sponsor of 540 studies on the registry; 34 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
Abbott has 1 study filed under Complex Regional Pain Syndromes — fewer than ten, so there is no comparison to draw.
8 of the studies in Complex Regional Pain Syndromes with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06798493Hospital for Special Surgery, New YorkCSS-SR Validation Study | 2026-12-29 |
| NCT05593237University of California, San FranciscoTranscranial Magnetic Stimulation for Chronic Neuropathic Pain | 2026-12-30 |
| NCT05477004Theresa LiiObservational Study of Ketamine Infusions for the Treatment of Chronic Pain | 2026-12-31 |
| NCT05777889Hospital for Special Surgery, New YorkInfrared Images for Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients | 2027-02 |
| NCT05814497Children's Hospital Medical Center, CincinnatiSupraspinal Processing of Sensory Aspects of Pain | 2027-06-30 |
Add all 8 to your calendar (.ics) → With an account.
Among the 88 studies in Complex Regional Pain Syndromes with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System) · Device: Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)
Electrical stimulation of the DRG using the Axium™ Neurostimulator System
Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.
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.
Time frame: throughout 12 month study
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.
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
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.
Time frame: 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.
Time frame: 12 months
The study enrolled a total of 426 subjects at 44 investigational sites. The first subject was enrolled in August 2016 and the last subject in December 2019. Completion of enrollment and follow-up in the study occurred in September 2021.
| Milestone | Dorsal Root Ganglion (DRG) Stimulation |
|---|---|
| Started | 426 |
| Completed | 198 |
| Not completed | 228 |
| Withdrew: Adverse event | 14 |
| Withdrew: Another device implanted | 1 |
| Withdrew: Device explanted | 1 |
| Withdrew: Device has been turned off since jan 2019 | 1 |
| Withdrew: Health issues | 1 |
| Withdrew: Insurance denial | 8 |
| Withdrew: No perm implant, active pain pump implanted | 1 |
| Withdrew: Patient did not obtain at least 50% pain relief | 1 |
| Withdrew: Screen failure | 1 |
| Withdrew: Sponsor request | 6 |
| Withdrew: Death | 3 |
| Withdrew: Subject implant at another facility | 1 |
| Withdrew: Lost to follow-up | 26 |
| Withdrew: Subject participation terminated by investigator | 17 |
| Withdrew: Subject and/or family request | 64 |
| Withdrew: Trial failure | 81 |
| Withdrew: Used different battery not approved for study at time of perm | 1 |
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.
| percentage of events | Dorsal Root Ganglion (DRG) Stimulation |
|---|---|
| Rate of Serious Adverse Events (SAEs) | 8.7 ± 1.7 |
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.
| percent | Dorsal Root Ganglion (DRG) Stimulation |
|---|---|
| Percent Change From Baseline to 12 Months Post-permanent Implant for Overall Pain Intensity Measured Using the Visual Analog Scale (VAS) | 44.48 ± 34.15 |
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.
| percent | Dorsal Root Ganglion (DRG) Stimulation |
|---|---|
| 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 | 5.13 ± 6.28 |
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.
| percent | Dorsal Root Ganglion (DRG) Stimulation |
|---|---|
| Physical Health | 6.22 ± 7.25 |
| Mental Health | 4.42 ± 8.19 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dorsal Root Ganglion (DRG) Stimulation | 3/426 (0.7%) | 26/426 (6.1%) | 5/426 (1.2%) |
| Event | Dorsal Root Ganglion (DRG) Stimulation |
|---|---|
| PneumoniaRespiratory, thoracic and mediastinal disorders | 5/426 |
| DeathGeneral disorders | 3/426 |
| EmbolismGeneral disorders | 2/426 |
| Gastrointestinal or Genitourinary CompromiseGastrointestinal disorders | 2/426 |
| CellulitisInfections and infestations | 1/426 |
| Acute Community Acquired PneumoniaRespiratory, thoracic and mediastinal disorders | 1/426 |
| Acute Respiratory FailureRespiratory, thoracic and mediastinal disorders | 1/426 |
| Altered Mental StatusPsychiatric disorders | 1/426 |
| Ankle SurgerySurgical and medical procedures | 1/426 |
| Bone FractureGeneral disorders | 1/426 |
| Event | Dorsal Root Ganglion (DRG) Stimulation |
|---|---|
| ClumsinessGeneral disorders | 2/426 |
| DizzinessGeneral disorders | 1/426 |
| Pain at the Implant SiteInjury, poisoning and procedural complications | 1/426 |
| Tibial Nerve SurgeryNervous system disorders | 1/426 |
| Age, Continuous(years) | Dorsal Root Ganglion (DRG) Stimulation |
|---|---|
| Mean | 52.7 ± 13.8 |
| Sex: Female, Male(Participants) | Dorsal Root Ganglion (DRG) Stimulation |
|---|---|
| Female | 259 |
| Male | 167 |
| Ethnicity (NIH/OMB)(Participants) | Dorsal Root Ganglion (DRG) Stimulation |
|---|---|
| Hispanic or Latino | 36 |
| Not Hispanic or Latino | 375 |
| Unknown or Not Reported | 15 |
| Race (NIH/OMB)(Participants) | Dorsal Root Ganglion (DRG) Stimulation |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 32 |
| White | 361 |
| More than one race | 17 |
| Unknown or Not Reported | 10 |
| Region of Enrollment(participants) | Dorsal Root Ganglion (DRG) Stimulation |
|---|---|
| United States | 426 |
| Complex Regional Pain Syndrome (CRPS)(Participants) | Dorsal Root Ganglion (DRG) Stimulation |
|---|---|
| CRPS I | 301 |
| CRPS II | 125 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2016 to primary completion in Sep 2021, 61 months.
Results were first posted in Jul 2024, 2 years 9 months after primary completion.
Of 18 observational studies under Complex Regional Pain Syndromes, half reached primary completion within 68 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 147. This study's 61 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Complex Regional Pain Syndromes →