Adults 22 to 75, any sex, with Complex Regional Pain Syndrome (CRPS). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Rate of Serious Adverse Events (SAEs)Primary· 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.
Group
Value
95% CI
Dorsal Root Ganglion (DRG) Stimulation
8.7
± 1.7
Percent Change From Baseline to 12 Months Post-permanent Implant for Overall Pain Intensity Measured Using the Visual Analog Scale (VAS)Secondary· 12 months
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.
Group
Value
95% CI
Dorsal Root Ganglion (DRG) Stimulation
44.48
± 34.15
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 ScaleSecondary· 12 months
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. R
Group
Value
95% CI
Dorsal Root Ganglion (DRG) Stimulation
5.13
± 6.28
Change From Baseline to 12 Months Post-permanent Implant for Quality of Life Measured Using the PROMIS Global Health ScaleSecondary· 12 months
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
Physical Health
Group
Value
95% CI
Dorsal Root Ganglion (DRG) Stimulation
6.22
± 7.25
Mental Health
Group
Value
95% CI
Dorsal Root Ganglion (DRG) Stimulation
4.42
± 8.19
Adverse events — posted to ClinicalTrials.gov
Time frame: 12 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Dorsal Root Ganglion (DRG) Stimulation
Serious: 26/426 (6%)
Deaths: 3/426
Serious adverse events (33 terms)
Reaction
System
Dorsal Root Ganglion (DRG)…
Pneumonia
Respiratory, thoracic and mediastinal disorders
—
Death
General disorders
—
Embolism
General disorders
—
Gastrointestinal or Genitourinary Compromise
Gastrointestinal disorders
—
Cellulitis
Infections and infestations
—
Acute Community Acquired Pneumonia
Respiratory, thoracic and mediastinal disorders
—
Acute Respiratory Failure
Respiratory, thoracic and mediastinal disorders
—
Altered Mental Status
Psychiatric disorders
—
Ankle Surgery
Surgical and medical procedures
—
Bone Fracture
General disorders
—
Brain Tumor
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Breast Cancer Diagnosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Abbott Medical Devices
Last refreshed: 8 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02800863.