NCT02256410

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2013

Completed
10 months until next milestone

First Posted

Study publicly available on registry

October 3, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

December 13, 2013

Last Update Submit

January 8, 2016

Conditions

Chronic Low Back Pain

Keywords

low back painchronic painsensitizationtreatmenttrigger points

Outcome Measures

Primary Outcomes (1)

  • 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 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

    measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)

  • The change in Pain Catastrophizing Scale

    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

    measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)

  • The change in average pain intensity

    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

    measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Other: Sham

Interventions

StimulationDEVICE

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

Also known as: Nervomatrix
Stimulation
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.

sham stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic low back pain persisting for at least 3 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrije Universiteit Brussel

Brussels, 1050, Belgium

Location

MeSH Terms

Conditions

Low Back PainChronic Pain

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jo Nijs, PhD

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

December 13, 2013

First Posted

October 3, 2014

Study Start

December 1, 2013

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

BE(1)