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Neuroscience Education and Spinal Manipulation on Health Locus of Control in Low Back Pain

NCT07639216 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-06-10

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effects of combining Pain Neuroscience Education (PNE) with spinal manipulation for individuals suffering from chronic low back pain. Participants will be randomly assigned to one of two groups: one group will receive the combined intervention (neuroscience education plus spinal manipulation), while the control group will receive spinal manipulation alone.

The primary goal of the researchers is to investigate whether this combined approach can help patients change their health locus of control-shifting from an external belief (that their health depends on external factors or clinicians) to an internal belief (that they have control over their own recovery and pain management). The total study period will last 3 months, consisting of 4 weeks of intervention followed by an 8-week follow-up period to assess long-term changes in pain intensity, disability, and health beliefs.

Conditions

  • Low Back Pain

Interventions

BEHAVIORAL

Pain Neuroscience Education (PNE)

A standardized 4-week educational program consisting of once-weekly, 30-minute face-to-face sessions led by an experienced physical therapist. The curriculum covers: 1) introduction to pain neurophysiology and modulation; 2) differentiating types of pain (nociceptive, nociplastic, neuropathic) and de-educating beliefs regarding imaging findings vs. actual tissue injury; 3) acute vs. chronic pain characteristics; and 4) movement-driven neuroplasticity, active lifestyle promotion, and minimizing nocebo beliefs (such as ideal posture, rest, and spine vulnerability).

PROCEDURE

Spinal Manipulation (SM)

High-velocity, low-amplitude (HVLA) spinal manipulation techniques applied to the lumbar spine based on clinical assessment. This mechanical intervention will be delivered to participants in both study arms over a 4-week period, using identical parameters of frequency, technique selection, and duration to isolate the additive effect of the educational protocol.

Sponsors & Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    collaborator OTHER_GOV

  • Centro Universitário Augusto Motta

    lead OTHER

Principal Investigators

  • Ivan A Barros, Pt, PhD student · Augusto Motta University Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07639216 on ClinicalTrials.gov