Chronic Low Back PainNCT02256410
Pain Detecting and Analgesic Stimulating Device on Low Back Pain
A study testing Stimulation in people with Chronic Low Back Pain, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic low back pain persisting for at least 3 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Pain Detecting and Analgesic Stimulating Device on Low Back Pain Patients' Clinical Outcomes
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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Stimulation, Sham
- Keywords
- low back pain, chronic pain, sensitization, treatment, trigger points
- Medical subject headings
- Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimulationDevice
Also called Nervomatrix
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
ShamOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Stimulation |
| 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. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
Secondary outcomes (6)
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.
Measured: 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: 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: 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: 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: 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: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jo Nijs, Vrije Universiteit Brussel
- Investigators
- Jo Nijs, PhD, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256410
- Sponsor's protocol ID
- NeMaLBP
- Status last verified
- Jan 2016
- First submitted
- 13 Dec 2013
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Pain Detecting and Analgesic Stimulating Device on Low Back Pain Patients' Clinical Outcomes
- ClinicalTrials.gov ID
- NCT02256410
- Acronym / sponsor ID
- NeMaLBP
- Conditions
- Chronic Low Back Pain
- Keywords
- low back pain, chronic pain, sensitization, treatment, trigger points
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 3 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulation | Experimental | Device: StimulationPatients 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. |
| sham stimulation | Sham comparator | Other: ShamPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic low back pain persisting for at least 3 months
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StimulationAlso: NervomatrixThe 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 | Device | Stimulation |
| ShamThe 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. | Other | sham stimulation |
Primary outcome
The change in the amount of steps climbed during one minute
Time frame: 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
6 secondary outcomes
The change in central sensitization inventory
Time frame: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
The change in Pain Catastrophizing Scale
Time frame: 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
Time frame: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
The change in average pain intensity
Time frame: 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
Time frame: 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
Time frame: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jo Nijs, PhD principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulation in people with Chronic Low Back Pain, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the amount of steps climbed during one minute (time frame: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.