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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation | Experimental | Patients will undergo 6 sessions, each including 20 minutes of stimulation. These are given after the Nervomatrix device determines the peak pain regions for each patient, and selects to stimulate the top 10 regions with least skin resistance. The frequency of stimulation is 8Hz, at an intensity matched for each patient's tolerance, without inflicting any pain. The location of the stimulations will change in accordance to the changes in the peak pain regions, reflecting changes in tissue physiology possibly linked to clinical improvements. |
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| sham stimulation | Sham Comparator | Patients will undergo 6 sessions, each including 20 minutesof sham stimulation (no stimulation). These are given after the Nervomatrix device determines the peak pain regions for each patient, and selects to stimulate the top 10 regions with least skin resistance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stimulation | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The change in the amount of steps climbed during one minute | 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 | measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| The change in central sensitization inventory | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jo Nijs, PhD | Vrije Universiteit Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vrije Universiteit Brussel | Brussels | 1050 | Belgium |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| Sham | Other | 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. |
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| measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks) |
| The change in Pain Catastrophizing Scale | 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. | measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks) |
| The change in revised Illness perception questionnaire | 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 | measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks) |
| The change in average pain intensity | average pain rating in the last seven days using a 100 mm Visual Analogue Scale (VAS) | measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks) |
| The change in Quebec Back Pain Disability Scale | 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. | measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks) |
| The change in Tampa Scale of Kinesiophobia | 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 | measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |