Chronic Low Back Pain
Conditions
Keywords
low back pain, chronic pain, sensitization, treatment, trigger points
Brief summary
Purpose of study is to test in a randomized controlled trial (RCT) the effects of the Nervomatrix device on various clinical outcomes of patients with low back pain, as well as its mechanisms of action.
Detailed description
This will be a matched randomized-controlled trial - RCT. Using random numbers from a random number generator, pairs of patients will be randomized to either the Nervomatrix stimulation (experimental group) or to sham stimulation (controls). Matching of pairs will be done based on the baseline data of the primary outcomes - pain and disability, as well as on other treatments received.
Interventions
DEVICEStimulation
The Nervomatrix device first measures skin impedance, and then creates a digital pain matrix map of the back. Regions with low resistance are then selected for brief electric stimulation, thus targeting the treatment to specific peak pain regions. Preliminary evidence supports the effectiveness of this device in reducing pain and disability over 6 sessions
OTHERSham
The Nervomatrix device first measures skin impedance, and then creates a digital pain matrix map of the back. Regions with low resistance are then selected for brief mechanical pressure.
Sponsors
Vrije Universiteit Brussel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* chronic low back pain persisting for at least 3 months
Exclusion criteria
* patho-anatomical diagnosis (such as fractures, tumors, rheumatic diseases and neurological diseases) * initiated a new conventional therapy during the study period * pregnant * patients having a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in the amount of steps climbed during one minute | measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks) | Stair climbing: Participants were asked to climb up and down 5 stairs for 1 minute, using the rail for support if required. The total amount of steps climbed will be recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in Pain Catastrophizing Scale | measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks) | will be used to assess pain catastrophizing. It consists of 13 items describing different thoughts and feelings that individuals may experience when they are experiencing pain. Items are scored on a 5-point scale, and total scores are counted by adding up all individual items scores. Higher scores correspond to more severe catastrophic thoughts about pain. |
| The change in revised Illness perception questionnaire | measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks) | will be used for assessing the patients' illness perceptions, as it is known that patients with maladaptive illness perceptions (e.g. expecting that their back problem will last for a long time, or holding weak beliefs in the controllability of their back problem) are more likely to have poor clinical outcomes 6 months after they consulted their physician |
| The change in central sensitization inventory | measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks) | Part A of 25 statements related to current health symptoms. Each of these items is measured on a 5-point temporal Likert scale, with the following numeric rating scale: never (0), rarely (1), sometimes (2), often (3), and always (4). A cumulative score ranges from 0 to 100. Additionally information is collected in Part B on previously diagnosed central sensitivity syndromes and related conditions. |
| The change in Quebec Back Pain Disability Scale | measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks) | This questionnaire consists of 20 activity related questions which the patient has to score on a six points scale (0= no; 5= not capable to perform the activity). The total score represents a percentage of functional limitations the patient experiences during daily life. |
| The change in Tampa Scale of Kinesiophobia | measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks) | Tampa Scale of Kinesiophobia is a 17-item questionnaire developed to measure the fear of movement and (re)injury. Each item is scored on a four-point Likert scale ranging from strongly disagree \[1\] to strongly agree \[4\]. Ratings are added up to give a total score ranging from 17-68 points, with the higher values reflecting greater fear of (re)injury |
| The change in average pain intensity | measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks) | average pain rating in the last seven days using a 100 mm Visual Analogue Scale (VAS) |
Countries
Belgium
Outcome results
None listed