Pain Detecting and Analgesic Stimulating Device on Low Back Pain
8. Januar 2016 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
39
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Brussel, Belgien, 1050
- Vrije Universiteit Brussel
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Schein-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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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The change in the amount of steps climbed during one minute
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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The change in central sensitization inventory
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Dezember 2013
Primärer Abschluss (Tatsächlich)
1. Dezember 2014
Studienabschluss (Tatsächlich)
1. Februar 2015
Studienanmeldedaten
Zuerst eingereicht
13. Dezember 2013
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
2. Oktober 2014
Zuerst gepostet (Schätzen)
3. Oktober 2014
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
12. Januar 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. Januar 2016
Zuletzt verifiziert
1. Januar 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NeMaLBP
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