Chronic back pain without previous history of lumbar spine surgery Musculoskeletal Diseases
Conditions
Interventions
Participants are randomly allocated in a 1:1 ratio to either the control or the intervention group.
Those in the intervention group receive the DTM SCS therapy. SCS involves the surgical placement of
Sponsors
SGX International LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be a candidate for SCS system (trial and implant) 2. Have been diagnosed with chronic, refractory axial low back pain with or without lower limb pain with a neuropathic component as assessed by the investigator, and are not eligible for spine surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) at the time of enrollment 3. Has an average back pain intensity = 6.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment 4. Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject’s participation has been provided 5. Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand and sign the written informed consent 6. Be 18 years of age or older at the time of enrollment 7. Be on a stable pain medication regimen, as determined by the study investigator, for at least 30 days prior to enrolling in this study 8. Be willing and able to comply with study-related requirements, procedures, and visits
Exclusion criteria
Exclusion criteria: 1. Had previous lumbar spinal surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) 2. Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available IntellisTM SCS systems as determined by the Investigator 3. Has a diagnosed back condition with inflammatory causes of back pain (e.g., onset of severe pain with activity), serious spinal pathology and/or neurological disorders as determined by the investigator 4. Be concurrently participating in another clinical study 5. Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump, etc. 6. Has a pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator 7. Has mechanical spine instability as determined by the Investigator 8. Has undergone, within 30 days prior to enrollment, an interventional procedure to treat back and/or leg pain, which is providing significant pain relief 9. Has unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the investigator 10. Be involved in an injury claim under current litigation or has a pending or approved worker’s compensation claim 11. Be pregnant (determined by urine testing unless female subject is surgically sterile or post-menopausal. If female, sexually active, and childbearing age, subject must be willing to use a reliable form of birth control)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Individual responder rate measured using the visual analog scale (VAS) (as defined by at least a 50% reduction in pain) at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Successful back pain relief measured using the visual analog scale (VAS) at 1, 3, 6, 9, 12, 18 and 24 months 2. Percentage of patients who experience at least 50% reduction in pain intensity measured using the VAS at 1, 3, 6, 9, 12, 18 and 24 months 3. Back pain intensity measured using VAS at baseline, 1, 3, 6, 9, 12, 18 and 24 months Removed 27/01/2022 (these were incorrectly listed as secondary outcome measures. In the protocol they are indicated as additional measures): 4. Disability measured using Oswestry Disability Index (ODI) questionnaire at 3, 6, 9, 12, 18 and 24 months 5. Quality of life measured using EQ-5D & SF-12 questionnaire at 3, 6, 12, 18 and 24 months 6. Health economic outcomes measured using clinic visits, incidence of adverse events, EQ-5D, SF-12 at 1, 3, 6, 9, 12, 18 and 24 months | — |
Countries
Belgium, Germany, Netherlands, Spain
Outcome results
None listed