Pain Detecting and Analgesic Stimulating Device on Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256410
• Other study ID #: NeMaLBP
• Status: Completed
• Phase: N/A
• First received: December 13, 2013
• Last updated: January 8, 2016
• Start date: December 2013
• Est. completion date: February 2015

Study information

• Verified date: January 2016
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Device:
• Stimulation
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:
• Sham
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.

Locations

Country	Name	City	State
Belgium	Vrije Universiteit Brussel	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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.	measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)	No
Secondary	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.	measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)	No
Secondary	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	measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)	No
Secondary	The change in average pain intensity	average pain rating in the last seven days using a 100 mm Visual Analogue Scale (VAS)	measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)	No
Secondary	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.	measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)	No
Secondary	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	measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)	No