Pulsed Direct Current Electrical Stimulation for Treatment of Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neubie Direct Current Stimulation Device.
- Who it may be relevant to
- Registry conditions: Back Pain, Low. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Pulsed Direct Current Electrical Stimulation (Neubie) on Low Back Pain
Overview
The goal of this interventional clinical trail is to determine the efficacy of the use of the Neubie pulsed direct current electrical stimulation device for the treatment of participants experiencing mechanical low back pain. The main question it aims to answer is: Does treatment with the Neubie improve symptoms and time to resolution of back pain compared to standard of care? Researchers will compare a 12 session treatment physical therapy regimen using the Neubie to standard of care to see if there is a difference in symptom severity and time to resolution. Participants will: * Visit the clinic 2 times a week to undergo active physical therapy treatments with or without electrical stimulation from the Neubie. * Undergo testing and fill out surveys on evaluation and final session on quality of life, disability, pain, and spinal mobility.
Detailed description
To determine the efficacy of direct current (DC) electrical stimulation (the Neubie device) on back pain, patients presenting with mechanical, non-radicular low back pain will enroll in a 4 to 6 week treatment regimen at EA Therapeutic Health. The first session will consist of an intake evaluation session that will include: Modified Oswestry Pain Scale, The Schober test for mobility, Heart Rate Variability, and Quality of Life Index. These tests will serve as baseline (and a within subject control) for the intervention.
Participants will then undergo a treatment protocol that incorporates either traditional physical therapy (PT) exercises (standard of care control) or PT exercises with the Neubie utilized concurrently (experimental group). Subjects will undergo an evaluation session prior to starting treatment that includes the Modified Oswestry Pain Scale, The Schober test for mobility, Heart Rate Variability, and Quality of Life Index.
The experimental group subjects will undergo 12 sessions of physical therapy over a 4 to 6-week period which include 45 min of various physical therapy exercises concurrently with the Neubie followed by a 15 minute passive Vagus nerve stimulation protocol with the Neubie.
Control group subjects will participate in a physical therapy protocol that includes manual therapy (e.g. trigger point release, mobilization of the sacroiliac (SI) joint and exercises for back strengthening and stretching. Experimental group subjects will participate in a physical therapy protocol that includes manual therapy (e.g. trigger point release, mobilization of the SI joint) and exercises for back strengthening and stretching in conjunction with Neubie DC e-stim. Both control and experimental groups will receive a customized Home Exercise Program with exercises to be performed at home 1 time a day.
Interventions
- Device Neubie Direct Current Stimulation Device
Pulsed Direct Current Electrical Stimulation Device
Primary outcome measures
- Modified Oswestry Disability Index [Time frame: Pre-intervention]
- Modified Oswestry Disability Index [Time frame: 6 weeks]
- Visual Analog Pain Scale [Time frame: Pre-intervention]
- Visual Analog Pain Scale [Time frame: 6 weeks]
- Schober Test [Time frame: Pre-intervention]
- Schober Test [Time frame: 6 weeks]
- Quality of Life Index [Time frame: Pre-intervention]
- Quality of Life Index [Time frame: 6 weeks]
- Heart Math HRV [Time frame: Pre-intervention]
- Heart Math HRV [Time frame: 6 weeks]
Eligibility criteria
Inclusion criteria
- Must show evidence of axial mechanical low back pain at least 3/10 on visual analog scale, without radiation to the lower limbs. Pain has to have been present for at least two weeks or diagnosed as chronic .
- Normal lower limb strength
- Able to attend twice weekly physical therapy visis for up to 6 weeks
- 18 years of age, or older
Exclusion criteria
- Currently pregnant
- Cardiac pacemaker
- Active or recently treated cancer
- Active or recent blood clots
- Epilepsy
- Open wounds
- History of lumbar spine fusion surgery
- Radicular symptoms suggesting radiculopathy or spinal stenosis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06984224 · Pro00086182