Chronic low back pain long-lasting lower back pain
Conditions
Interventions
Treatment of the patients with the Optimedic Dynamic Neuromodulator for 4 weeks
(2 * 30 min treatment / week).
Sponsors
Optimedic B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Chronic low back pain: The pain has been present for over 12 months; the pain has outlasted the normal tissue healing time; the impairment is greater than is to be expected based on the injury or tissue damage; appears in the absence of tissue damage - There is no apparent acute cause for the low back pain - Stable pain levels - Aged 18 or above - Cognitively able to follow instructions and able to understand the Dutch or English questionnaires.
Exclusion criteria
Exclusion criteria: - Comorbidity depression or anxiety, defined as score >= 21 on the Beck Depression Inventory (BDI) scale - The chronic pain is a result of a lesion - Severe cognitive or memory impairments (Mini-Mental State Examination (MMSE) >23) - Subject has moderate, advanced or late-stage dementia - Subject has a history of the following conditions: - Rheumatoid arthritis - Arrhythmia - Seizures (e.g., epileptic seizures) - Other auto-immune disease - Subject has an end-stage disease or terminal illness (e.g., end-stage kidney disease, end-stage heart disease, end-stage liver disease or pancreatic cancer). - Subject has an implantable electrical device (e.g. pacemakers, implanted neuro stimulator, implanted medicine pump). - Subject has metal hardware (rods or similar) that holds 3 or more vertebrae in place.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the feasibility of a newly proposed method with the non-invasive Optimedic dynamic neuromodulator for chronic low back pain patients. The primary outcome is a recommendation from stakeholders for the used protocol and device. Staceholders are the local researchers and product owners. | — |
Secondary
| Measure | Time frame |
|---|---|
| The pain experience, measured over the past week and the behaviour accompanying pain (Visual Analogue Scale). Average and Peak VAS score over the past week. The outcome is the difference between the mean change in pain from baseline to immediately after the intervention and 8 weeks after the intervention. Another secondary study parameter is the function disability score measured with the Quebec Back Pain Disability Scale (QBPDS). The QBPDS contains assessments of elementary daily activities that patients with back pain might perceive difficult to perform. Items can be classified into 6 domains of activity affected by back pain: bed/rest (items 1-3), sitting/standing (items 4- 6), ambulation (items 7-9), movement (items 10-12), bending/stooping (items 13- 16), and handling of large/heavy objects (items 17-20). Scores range from 0 (no disability) to 100 (maximal disability). The secondary outcome is the difference from baseline to immediately after the intervention and 8 weeks after the intervention in improvement of functional disability. Other parameters that are measured are sleep quality score (0-10) and quality of life score (0-10). The outcome is the difference from baseline to immediately after the intervention and 8 weeks after the intervention in improvement of sleep score and quality of life score. | — |
Countries
Netherlands
Outcome results
None listed