Pain Detecting and Analgesic Stimulating Device on Low Back Pain
8. januar 2016 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
39
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Brussel, Belgien, 1050
- Vrije Universiteit Brussel
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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
Andre navne:
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Sham-komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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The change in the amount of steps climbed during one minute
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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The change in central sensitization inventory
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2013
Primær færdiggørelse (Faktiske)
1. december 2014
Studieafslutning (Faktiske)
1. februar 2015
Datoer for studieregistrering
Først indsendt
13. december 2013
Først indsendt, der opfyldte QC-kriterier
2. oktober 2014
Først opslået (Skøn)
3. oktober 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
12. januar 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. januar 2016
Sidst verificeret
1. januar 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NeMaLBP
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