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

ConditionLow Back Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCentro Universitário Augusto Motta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Both sexes.

Aged between 18 and 60 years.

Diagnosed with non-specific chronic low back pain (lasting 3 months or longer).

Functional disability score of 4 points or higher on the Roland-Morris Disability Questionnaire.

Disqualifiers

Pregnant women.

Main area of pain is not located in the lumbar spine.

Main pain is located in the leg.

Less than 6 months post-surgery in the lumbar spine, lower limbs, or abdominal region.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    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.

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: PNE + Spinal ManipulationExperimental treatment 2 interventions
Group B: Spinal Manipulation AloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Health Locus of Control

Measured using the Multidimensional Health Locus of Control (MHLC) scale. The questionnaire consists of 18 items divided into three distinct subscales: Internal, External, and Chance. Each item is scored on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). The total score for each subscale is calculated by summing its 6 specific items, resulting in a score ranging from 6 to 36 per subscale. Higher scores in a specific subscale indicate a stronger belief in that particular dimension of 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).

Secondary outcomes

1

Change in Pain Intensity

Measured using the Numerical Pain Rating Scale (NPRS). The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "unbearable pain". Higher scores represent greater pain severity.

Time frame
Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months).
2

Change in Functional Disability

Measured using the Roland-Morris Disability Questionnaire (RMDQ). The questionnaire consists of 24 yes/no items, scored as 1 for agreement and 0 for disagreement. The total score ranges from 0 to 24, where higher scores indicate greater functional disability due to chronic low back pain. Scores above 14 indicate significant disability.

Time frame
Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months).
3

Change in Patient-Specific Functional Scale

Measured using the Patient-Specific Functional Scale (PSFS). Participants identify up to three important activities limited by low back pain and rate their current ability on an 11-point scale from 0 ("unable to perform activity") to 10 ("able to perform activity at pre-injury level"). The total score ranges from 0 to 30, where higher scores indicate greater specific functional capacity.

Time frame
Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months.
4

Change in Pain Catastrophizing

Measured using the Pain Catastrophizing Scale (PCS). It consists of 13 items scored on a 5-point Likert scale from 0 (minimum/not at all) to 4 (very intense/all the time), divided into three domains: magnification (items 6, 7, 13), rumination (items 8-11), and helplessness (items 1-5, 12). The total score is computed by summing all items, ranging from 0 to 52, where higher scores indicate higher levels of pain catastrophizing.

Time frame
Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centro Universitário Augusto Motta

Lead sponsor

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Collaborator

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