Back to resultsPain Detecting and Analgesic Stimulating Device on Low Back Pain
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Stimulation
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring low back pain, chronic pain, sensitization, treatment, trigger points
Eligibility Criteria
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
Sites / Locations
- Vrije Universiteit Brussel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Stimulation
sham stimulation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The change in central sensitization inventory
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.
The change in Pain Catastrophizing Scale
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.
The change in revised Illness perception questionnaire
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
The change in average pain intensity
average pain rating in the last seven days using a 100 mm Visual Analogue Scale (VAS)
The change in Quebec Back Pain Disability Scale
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.
The change in Tampa Scale of Kinesiophobia
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
Full Information
NCT ID
NCT02256410
First Posted
December 13, 2013
Last Updated
January 8, 2016
Sponsor
Vrije Universiteit Brussel
1. Study Identification
Unique Protocol Identification Number
NCT02256410
Brief Title
Pain Detecting and Analgesic Stimulating Device on Low Back Pain
Official Title
The Effects of a Pain Detecting and Analgesic Stimulating Device on Low Back Pain Patients' Clinical Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
low back pain, chronic pain, sensitization, treatment, trigger points
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
sham stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Stimulation
Other Intervention Name(s)
Nervomatrix
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
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 Outcome Measure Information:
Title
The change in the amount of steps climbed during one minute
Description
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
Time Frame
measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
Secondary Outcome Measure Information:
Title
The change in central sensitization inventory
Description
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.
Time Frame
measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
Title
The change in Pain Catastrophizing Scale
Description
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.
Time Frame
measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
Title
The change in revised Illness perception questionnaire
Description
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
Time Frame
measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
Title
The change in average pain intensity
Description
average pain rating in the last seven days using a 100 mm Visual Analogue Scale (VAS)
Time Frame
measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
Title
The change in Quebec Back Pain Disability Scale
Description
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.
Time Frame
measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
Title
The change in Tampa Scale of Kinesiophobia
Description
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
Time Frame
measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo Nijs, PhD
Organizational Affiliation
Vrije Universiteit Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vrije Universiteit Brussel
City
Brussel
ZIP/Postal Code
1050
Country
Belgium
12. IPD Sharing Statement
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Pain Detecting and Analgesic Stimulating Device on Low Back Pain
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