Pain Detecting and Analgesic Stimulating Device on Low Back Pain
8 januari 2016 bijgewerkt door: Jo Nijs, Vrije Universiteit Brussel
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
39
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Brussel, België, 1050
- Vrije Universiteit Brussel
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Stimulation
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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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
Andere namen:
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Sham-vergelijker: sham stimulation
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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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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The change in the amount of steps climbed during one minute
Tijdsspanne: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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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
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measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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The change in central sensitization inventory
Tijdsspanne: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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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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measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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The change in Pain Catastrophizing Scale
Tijdsspanne: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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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.
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measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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The change in revised Illness perception questionnaire
Tijdsspanne: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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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
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measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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The change in average pain intensity
Tijdsspanne: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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average pain rating in the last seven days using a 100 mm Visual Analogue Scale (VAS)
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measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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The change in Quebec Back Pain Disability Scale
Tijdsspanne: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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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.
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measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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The change in Tampa Scale of Kinesiophobia
Tijdsspanne: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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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
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measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 december 2013
Primaire voltooiing (Werkelijk)
1 december 2014
Studie voltooiing (Werkelijk)
1 februari 2015
Studieregistratiedata
Eerst ingediend
13 december 2013
Eerst ingediend dat voldeed aan de QC-criteria
2 oktober 2014
Eerst geplaatst (Schatting)
3 oktober 2014
Updates van studierecords
Laatste update geplaatst (Schatting)
12 januari 2016
Laatste update ingediend die voldeed aan QC-criteria
8 januari 2016
Laatst geverifieerd
1 januari 2016
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NeMaLBP
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