To investigate the feasibility of a newly proposed method with the non-invasive Optimedic dynamic neuromodulator for chronic low back pain patients. Stakeholders will be interviewed to objectify the feasibility of the methods used in this study.A…
ID
Source
Brief title
Condition
- Bone and joint injuries
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Chronic pain is a global problem, with a prevalence of 20-25% and an incidence
of 1 in 10 worldwide. It is a disease with multiple components (sensory,
affective and cognitive) and it hereby affects the life of the patient in
different areas, it influences their well-being; ability to maintain an
independent lifestyle; sleep pattern; productivity (at work); and social
relationships. The greatest contributor is chronic low back pain and therefore
the focus of this research will be on the treatment of chronic low back pain
with a new neuromodulatory device, the Optimedic dynamic neuromodulator.
Current treatments like medication, physical therapy, and Transcutaneous
electrical nerve stimulation (TENS) can have positive results, but mostly
temporary and not for all patients. Therefore, we are looking for new
treatments to relieve the pain.
Study objective
To investigate the feasibility of a newly proposed method with the non-invasive
Optimedic dynamic neuromodulator for chronic low back pain patients.
Stakeholders will be interviewed to objectify the feasibility of the methods
used in this study.
A secondary objective of this intervention study is to investigate the changes
on pain experience after of treatment with the Optimedic Dynamic
Neuromodulator, measured with the Visual Analogue pain Scale (VAS).
Further secondary objectives are to Investigate the changes on scoring on the
disability and daily living (Quebec back pain disability scale, (QBPDS), sleep
quality scale and life quality scale, after treatment with the Optimedic
Dynamic Neuromodulator.
Study design
Pilot-Intervention study with a patient population (chronic low back pain). All
patients will receive the treatment with the Optimedic neuromodulator, 2 times
per week for 4 weeks. VAS pain scale, QBPDS, sleep quality scale and life
quality scale will be rated before (t0), after the intervention (t1) and after
an 8 week follow up (t2).
Intervention
Treatment of the patients with the Optimedic Dynamic Neuromodulator for 4 weeks
(2 * 30 min treatment / week).
Study burden and risks
The benefits for the participants are that they get a new, additional treatment
for their chronic low back pain that is not harmful and potentially reliefs the
pain and improves their quality of live.
All tests will be performed by educated and specifically trained personnel in
controlled environments, using standardised protocols that guarantee patient
safety. Therefore, it is expected that significant risks will not occur. TENS
is already used for years in clinical research and pain treatment. There are no
documented risks for this treatment when using a wearable device like the
Optimedic neuromodulator.
In addition, a risk classification has been performed, using the NFU risk
classification list and table. Based on these tables, it is safe to conclude
that the participants in this study are at no risk. (see protcol page 34)
Blokstallen 2
Bergen op Zoom 4611 WB
NL
Blokstallen 2
Bergen op Zoom 4611 WB
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80429.000.22 |