Chronic low back pain Musculoskeletal Diseases Low back pain
Conditions
Interventions
This is a prospective observational cohort study monitoring patients up to 1 year following activation of the ReActiv8 device. Only patients who have appropriately diagnosed chronic low back pain of m
Sponsors
Leeds Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years to =75 years 2. Chronic low back pain on the majority of days 12 weeks prior to enrolment 3. Continuing low back pain despite more than 90 days under medical management within last year
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 31/05/2024: 1. BMI >35 kg/m² 2. Any current indication for back surgery 3. Leg pain worse than back pain or radiculopathy below the knee Back pain exclusions: 4. Any diagnosis or correction of scoliosis 5. Neurological deficit (e.g., foot drop) 6. Sacroiliac joint pain 7. NRS of =5.0 and >9.0 at the Baseline Evaluation 8. ODI score 60% at enrolment Drug use exclusions: 9. Baseline use >120 mg oral morphine equivalent per day of opioids 10. Medications not at stable dose in prior 30 days Surgical exclusions: 11. Rhizotomy procedure of medial branch below T8 in 35 kg/m² 2. Any current indication for back surgery 3. Leg pain worse than back pain or radiculopathy below the knee 4. Any diagnosis or correction of scoliosis 5. Neurological deficit (e.g. foot drop) 6. Sacroiliac joint pain 7. NRS =5.0 and >9.0 at baseline 8. ODI score 60% at enrolment 9. PainDETECT score >19 at enrolment 10. Baseline use >120 mg oral morphine equivalent per day of opioids 11. Medications not at stable dose in prior 30 days 12. Rhizotomy procedure of medial branch below T8 in < 12 months 13. Anaesthetic block of medial branch or epidural steroids for back pain in prior 30 days 14. Previous back surgery below T8 15. Previous destructive thoracic or lumbar sympathectomy 16. Current/pending litigation, claim or monetary settlement 17. Closed claim in past five years, or financial incentive to remain impaired 18. Current active depression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain measured using the numerical rating scale (NRS) at baseline, injection 1, injection 2, and 1 month, 3 months, 6 months and 12 months post-activation of the ReActiv8 device 2. Functional disability measured using the Oswestry Disability Index (ODI) at baseline and 3 months, 6 months and 12 months post-activation of the ReActiv8 device | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health-related quality of life measured using the EQ-5D at baseline and 3 months, 6 months and 12 months post-activation of the ReActiv8 device 2. Medication use recorded using questionnaire at baseline and 3 months, 6 months and 12 months post-activation of the ReActiv8 device 3. Work status recorded using questionnaire at baseline and 3 months, 6 months and 12 months post-activation of the ReActiv8 device 4. Physical function measured using the sit-to-stand and 5-minute walk tests at baseline and 3 months, 6 months and 12 months post-activation of the ReActiv8 device | — |
Countries
England, United Kingdom
Contacts
Public ContactEmma Binns
Outcome results
None listed