Pain Detecting and Analgesic Stimulating Device on Low Back Pain

Vrije Universiteit Brussel

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Other: Sham; Device: Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02256410

NeMaLBP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 2 patient groups

Stimulation

Experimental group

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.

Treatment:

Device: Stimulation

sham stimulation

Sham Comparator group

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.

Treatment:

Other: Sham