Pain Detecting and Analgesic Stimulating Device on Low Back Pain
8. januar 2016 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
39
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Brussel, Belgia, 1050
- Vrije Universiteit Brussel
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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 navn:
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2013
Primær fullføring (Faktiske)
1. desember 2014
Studiet fullført (Faktiske)
1. februar 2015
Datoer for studieregistrering
Først innsendt
13. desember 2013
Først innsendt som oppfylte QC-kriteriene
2. oktober 2014
Først lagt ut (Anslag)
3. oktober 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
12. januar 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. januar 2016
Sist bekreftet
1. januar 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NeMaLBP
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