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NCT Number: NCT02256410

Pain Detecting and Analgesic Stimulating Device on Low Back Pain

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.

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Key information

Conditions

Chronic Low Back Pain Back Pain Chronic Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vrije Universiteit Brussel

Brussels, 1050, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stimulation

Device

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

Other names: Nervomatrix

SHAM

Other

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.

Primary outcomes

  1. The change in the amount of steps climbed during one minute

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

    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

Secondary outcomes

  1. The change in central sensitization inventory

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

    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.

  2. The change in Pain Catastrophizing Scale

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

    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.

  3. The change in revised Illness perception questionnaire

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

    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

  4. The change in average pain intensity

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

    average pain rating in the last seven days using a 100 mm Visual Analogue Scale (VAS)

  5. The change in Quebec Back Pain Disability Scale

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

    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.

  6. The change in Tampa Scale of Kinesiophobia

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

    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

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Official study title

The Effects of a Pain Detecting and Analgesic Stimulating Device on Low Back Pain Patients' Clinical Outcomes

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Oct 3, 2014
Registry last updated
Jan 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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