Low Back Pain Back Pain
Conditions
Interventions
This is a randomized
two-arm
unblinded
parallel-design clinical trial
The randomization process will be simple and will occur using identical
sealed
and sequentially numbered opaque envelopes containing the group names
Participants will be human volunteers clinically diagnosed with chronic low back pain
The study will be conducted without the use of blinding methods due to the inherent and physical nature of the physiotherapy intervention
The intervention group will consist of fifty participants who will undergo a protocol consisting of ten consecutive sessions of electroanalgesia based on the use of artificial neurons generated throug
The therapeutic frequency will consist of sessions performed five times a week
distributed over two consecutive weeks of treatment
totaling ten sessions
with an exact and timed duration of forty uninterrupted minutes per session
The control group will consist of fifty participants who will not receive any type of electrotherapy intervention
simulated electrical device
or placebo intervention
These individuals will participate exclusively in the same routines of clinical assessments
completion of standardized questionnaires and serial follow-up protocols carried out by members of the active intervention group
Sponsors
Centro Universitário das Faculdades Associadas de Ensino - FAE/UNIFAE
Centro Universitário das Faculdades Associadas de Ensino - FAE/UNIFAE
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Adults between 18 and 65 years of age of both sexes with a clinical diagnosis of chronic low back pain for at least 3 months will be included
Exclusion criteria
Exclusion criteria: Individuals with previous lumbar surgeries; pacemaker use; pregnant women; individuals with severe neurological diseases; presence of systemic inflammatory processes; cancer diagnosis; those involved in labor litigation related to low back pain will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: pain intensity; measured using the Visual Analogue Scale (VAS); A score of zero represents no pain; and ten represents the worst pain imaginable pain; pain intensity will be recorded at baseline; immediately before and immediately after each of the ten sessions of the protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| A reduction in kinesiophobia is expected; as measured by the Tampa Scale for Kinesiophobia (TSP); composed of seventeen self-report items; with responses on a four-point Likert scale; assessed at baseline and immediately after the tenth session;A reduction in functional disability is expected; as measured by the Oswestry Disability Index 2 (ODI); composed of ten sections that assess aspects of daily life; with scores per section ranging from zero to five and a total score converted to a percentage; assessed at baseline and immediately after the tenth section;A reduction in pain catastrophizing is expected; as measured by the modified version of the Pain Catastrophizing Scale (B-PCS); composed of thirteen questions on a scale of zero to four; measuring the frequency of pain-related thoughts and feelings encompassing the domains of helplessness; rumination and magnification; assessed at baseline and immediately after the tenth session;It is expected that the safety and tolerability of the intervention will be observed | — |
Countries
BR
Contacts
Public ContactAmir Omeiri
Centro Universitário das Faculdades Associadas de Ensino - FAE/UNIFAE
Outcome results
None listed