Dynamic Neuromodulation in Patients with Chronic Lower Back Pai

Conditions: Chronic low back pain
long-lasting lower back pain
10005942
10023213

Registration Number: NL-OMON51303

Lead Sponsor: Optimedic B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 62

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

- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the feasibility of a newly proposed method with the<br /><br>non-invasive Optimedic dynamic neuromodulator for chronic low back pain<br /><br>patients. The primary outcome is a recommendation from stakeholders for the<br /><br>used protocol and device. Staceholders are the local researchers and product<br /><br>owners. </p><br>

Secondary Outcome Measures