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

NCT07639216 | Not Yet Recruiting

• 1 other identifier: CAAE: 92856425.6.0000.5235
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

internal-external control; low back pain; spinal manipulation; pain education

Outcome Measures

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.

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

Secondary Outcomes (5)

• Change in Pain Intensity

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

• Change in Functional Disability

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

• Change in Patient-Specific Functional Scale

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

• Change in Pain Catastrophizing

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

• Change in Kinesiophobia

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

Study Arms (2)

PNE + Spinal Manipulation

EXPERIMENTAL

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.

Behavioral: Pain Neuroscience Education (PNE); Procedure: Spinal Manipulation (SM)

Spinal Manipulation Alone

ACTIVE COMPARATOR

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.

Procedure: Spinal Manipulation (SM)

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).

PNE + Spinal Manipulation

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.

PNE + Spinal Manipulation; Spinal Manipulation Alone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Has not received manual therapy for their condition within the previous 3 months.
• Able to understand Portuguese well enough to complete the study questionnaires.

You may not qualify if:

• 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.
• Has undergone any invasive procedure for pain relief within the last 3 months.
• Scoliosis.
• Rheumatological diseases.
• Progressive neurological disease.
• Disorders related to red flags, such as malignancy/cancer, acute trauma (e.g., car or motorcycle accidents), fractures, infection, or spinal cord/cauda equina compression.
• Chronic low back pain persisting after previous spinal surgery.

Sponsors & Collaborators

• Centro Universitário Augusto Motta: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Chiropractic Outpatient Clinic, Faculdades Reunidas da ASCE

Rio de Janeiro, Rio de Janeiro, 21050-660, Brazil

Location

Related Publications (1)

• Oliveira VC, Furiati T, Sakamoto A, Ferreira P, Ferreira M, Maher C. Health locus of control questionnaire for patients with chronic low back pain: psychometric properties of the Brazilian-Portuguese version. Physiother Res Int. 2008 Mar;13(1):42-52. doi: 10.1002/pri.391.

  PMID: 18225853 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Ivan A Barros, Pt, PhD student

  Augusto Motta University Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan A Barros, PT, PhD student

CONTACT

+55 21 98350-0099; ivanbarros.fisio@gmail.com

Luciana C Lunkes, PT, PhD

CONTACT

+55 35 9147-2550; lucianalunkes@souunisuam.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical outcomes will be evaluated by a blinded assessor who is completely unaware of the participants' group allocation throughout the entire study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two-arm, randomized, controlled trial with a parallel group design. Participants will be allocated to either the experimental group (receiving Pain Neuroscience Education combined with spinal manipulation) or the control group (receiving spinal manipulation alone). Both groups will undergo their respective protocols concurrently over a 4-week period, with clinical assessments conducted at baseline, immediately post-treatment, and at an 8-week follow-up.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

BR (1)