Clinical trial NCT02256410: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: low back pain
chronic pain
sensitization
treatment
trigger points
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2014-10-03
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The change in the amount of steps climbed during one minute
timeFrame: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
Secondary outcomes:
measure: The change in central sensitization inventory
timeFrame: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
measure: The change in Pain Catastrophizing Scale
timeFrame: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
measure: The change in revised Illness perception questionnaire
timeFrame: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
measure: The change in average pain intensity
timeFrame: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
measure: The change in Quebec Back Pain Disability Scale
timeFrame: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
measure: The change in Tampa Scale of Kinesiophobia
timeFrame: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Vrije Universiteit Brussel
Study officials:
affiliation: Vrije Universiteit Brussel
name: Jo Nijs, PhD
role: PRINCIPAL_INVESTIGATOR
References: