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

Sponsor
Centro Universitário Augusto Motta
Study ID
NCT07639216
Status
Not Yet Recruiting

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Conditions

  • Low Back Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Pain Neuroscience Education (PNE) — BEHAVIORAL
    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).
  • Spinal Manipulation (SM) — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Jun 10, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PNE + Spinal Manipulation
    Participants in this group will receive a combination of Pain Neuroscience Education (PNE) and high-velocity, low-amplitude spinal manipulation. The PNE program consists of once-weekly, 30-minute sessions for 4 weeks, focusing on the neurophysiology of pain and the de-education of maladaptive health beliefs. Spinal manipulation will be applied to the lumbar during the same period.
  • Active Comparator: Spinal Manipulation Alone
    Participants in this group will receive the exact same high-velocity, low-amplitude spinal manipulation protocol applied to the lumbar (same techniques, frequency, and duration over the 4-week period). However, they will only receive the manual therapy sessions, without any additional educational components, instructions, or materials.

Primary Outcome Measure

Change in Health Locus of Control [ Time Frame: Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months). ]

Central Contacts

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