1. to test differences in movement patterns during a standardized lifting task and gait between patients with chronic low back pain with high central sensitization (CS+), low back pain with low/moderate central sensitization (CS-) and healthy…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
A-specifieke chronische lage rugpijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The patients with chronic low back pain will be categorized into two subgroups
between CS+ and CS-. This will be carried out with the central sensitization
inventory (CSI) based on standardized cut-off scores. Main endpoints will be
tested in the movement laboratories of both the UMCG-Beatrixoord (patients) and
Saxion university of applied sciences (healthy controls). Movement analyses
will be performed using Vicon movement analysis system. To test differences in
motor control between the groups, we will apply Principal Component Analyses to
measure and compare their loadings using motion capture data.
Secondary outcome
1. Quantitative Sensory Testing: QST is a psychophysical method that is used to
assess the somatosensory function. In this study, the assessment will consist
three sensory tests, 1) Cuff-algometry (CA), 2) Temporal Summation of Pain
(TSP), and 3) activation of Conditioned Pain Modulation (CPM). These tests will
be used in all the three groups.
2. Nummeric Rating Scale for Pain: A pain rating scale will be administered to
rate current pain intensity by giving a number between 0 and 10 (0 = no pain,
and 10 = maximum pain imaginable). This scale will be used just in the patients
groups.
3. Surface Electromyography derived from m. biceps and quadriceps femoris in
both lower limbs with 4 EMG sensors. Two EMG sensors are placed at the erector
spinae bilaterally. Finally, another 3 EMG sensors at the trapezius descendens,
pectoralis major, and anterior deltoid muscules will be placed. all placements
will be carried out following SENIAM methods.
4. Ground reaction forces during lifting and gait.
Background summary
Increasing evidence suggests that in prolonged Low Back Pain, pain processing
alters as a consequence of central sensitization (CS). It is unknown how CS is
related to the ability to perform functional tasks (in this case lifting and
gait).
Study objective
1. to test differences in movement patterns during a standardized lifting task
and gait between patients with chronic low back pain with high central
sensitization (CS+), low back pain with low/moderate central sensitization
(CS-) and healthy controls.
2.to test differences in movement patterns during a standardized lifting task
overtime during the course of a rehabilitation program.
Study design
1st research question: a cross sectional case-control.
2nd research question: a within-subject prospective study design
Study burden and risks
This study can only be done using these patients* groups. There are negligible
injury risks and/or burdens and safety of the lifting test has previously been
tested on safety in patients with low back pain and healthy controls.
Quantified Sensory Testing, a secondary measure, is applied worldwide and
considered a safe technique to quantify pain processing.
Dilgtweg 5
Haren 9750RA
NL
Dilgtweg 5
Haren 9750RA
NL
Listed location countries
Age
Inclusion criteria
1. Age >=18
2. Have to experienced back pain more than 3 months
3. Non-specific CLBP confirmed by a physiatrist of UMCG Pain
Rehabilitation.Admitted to a 12 week pain rehabilitation program
4. Have reported a minimal pain level of 3 on the 0-10 pain numerical rating
scale (NRS)
5. Signed informed consent
Exclusion criteria
1.. Spinal pathologies, such as fractures, tumours or inflammatory diseases,
such as ankylosing spondylitis, nerve root compromise will be confirmed by
clinical neurological tests (disk herniation and spondylolisthesis with
neurological involvement, infection, malignancy, rheumatic, narrowing of spinal
canal and other conditions) or severe cardiorespiratory diseases
2. Diseases affecting sensory processing (eg. diabetes, alcohol or substance
abuse, neuropathy)
3. Back surgery in the past 2 years
4. Patients using neuroleptics, benzodiazepines or regular / strong opioids
Design
Recruitment
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 | NL78448.042.21 |