Low Back PainLHC-LBPNCT07639216
Neuroscience Education and Spinal Manipulation on Health Locus of Control in Low Back Pain
A study testing Pain Neuroscience Education (PNE) and Spinal Manipulation (SM) in people with Low Back Pain, run by Centro Universitário Augusto Motta at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Pain Neuroscience Education (PNE) and Spinal Manipulation (SM)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Chiropractic Outpatient Clinic, Faculdades Reunidas da ASCE
Rio de Janeiro, Rio de Janeiro, 21050-660
Ivan A Barros, PT, PhD student, +55 21 98350-0099, ivanbarros.fisio@gmail.com
Luciana C Lunkes, PT, PhD, +55 35 9147-2550, lucianalunkes@souunisuam.com.br
About this study
Official title: Pain Neuroscience Education Associated With Spinal Manipulation on Shifting Health Locus of Control in Patients With Low Back Pain: A Randomized Controlled 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.
Read the detailed description
Study Protocol and Randomization Eligible participants with chronic low back pain will be randomly allocated into one of the two study arms using a computer-generated random sequence. To ensure allocation concealment, this sequence will be managed by an independent researcher who is not involved in the recruitment, assessment, or treatment of the patients.
Intervention Groups Combined Group (PNE + Spinal Manipulation): Participants in this group will receive Pain Neuroscience Education (PNE) sessions combined with spinal manipulation. The PNE program will focus on the neurophysiology of pain, biopsychosocial factors, and de-education of maladaptive beliefs about spine vulnerability. Each education session will last approximately 30 minutes and will be delivered once a week for 4 weeks. Following or preceding the education, high-velocity, low-amplitude spinal manipulation techniques will be applied to the lumbar region based on clinical assessment.
Control Group (Spinal Manipulation Alone): Participants in this group will receive the exact same spinal manipulation protocol (same techniques, frequency, and duration over the 4-week period). However, they will only receive the manual therapy sessions, without any additional educational components or instructions.
Assessments and Follow-up Clinical outcomes, including health locus of control, pain intensity, and disability, will be evaluated at three specific time points: at baseline (before the first intervention), post-treatment (immediately after the 4-week intervention period), and at follow-up (8 weeks after the end of treatment, totaling 3 months of study participation). All evaluations will be performed by a blinded assessor who is unaware of the participants' group allocation.
- Conditions
- Low Back Pain
- Being tested
- Pain Neuroscience Education (PNE), Spinal Manipulation (SM)
- Keywords
- internal-external control, low back pain, spinal manipulation, pain education
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience Education (PNE)Behavioural
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 or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Spinal Manipulation (SM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months).
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.
Measured: 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
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.
Measured: Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months.
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.
Measured: Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months.
Change in Kinesiophobia
Measured using the Tampa Scale for Kinesiophobia (TSK). This self-administered questionnaire consists of 17 items scored on a 4-point Likert scale from 1 ("strongly disagree") to 4 ("strongly agree"). Items 4, 8, 12, and 16 are reverse-scored. The total score ranges from 17 to 68, where higher scores indicate a greater fear of movement and re-injury.
Measured: Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitário Augusto Motta
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Sponsor
- Investigators
- Ivan A Barros, Pt, PhD student, Principal investigator, Augusto Motta University Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639216
- Sponsor's protocol ID
- CAAE: 92856425.6.0000.5235
- Acronym
- LHC-LBP
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share individual participant data is still under consideration and will be finalized upon study completion, subject to institutional ethical review board guidelines and investigator consensus.
Publications
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.
PubMed 18225853
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Neuroscience Education Associated With Spinal Manipulation on Shifting Health Locus of Control in Patients With Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07639216
- Acronym / sponsor ID
- LHC-LBP / CAAE: 92856425.6.0000.5235
- Conditions
- Low Back Pain
- Keywords
- internal-external control, low back pain, spinal manipulation, pain education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Centro Universitário Augusto MottaUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Protocol and Randomization Eligible participants with chronic low back pain will be randomly allocated into one of the two study arms using a computer-generated random sequence. To ensure allocation concealment, this sequence will be managed by an independent researcher who is not involved in the recruitment, assessment, or treatment of the patients.
Intervention Groups Combined Group (PNE + Spinal Manipulation): Participants in this group will receive Pain Neuroscience Education (PNE) sessions combined with spinal manipulation. The PNE program will focus on the neurophysiology of pain, biopsychosocial factors, and de-education of maladaptive beliefs about spine vulnerability. Each education session will last approximately 30 minutes and will be delivered once a week for 4 weeks. Following or preceding the education, high-velocity, low-amplitude spinal manipulation techniques will be applied to the lumbar region based on clinical assessment.
Control Group (Spinal Manipulation Alone): Participants in this group will receive the exact same spinal manipulation protocol (same techniques, frequency, and duration over the 4-week period). However, they will only receive the manual therapy sessions, without any additional educational components or instructions.
Assessments and Follow-up Clinical outcomes, including health locus of control, pain intensity, and disability, will be evaluated at three specific time points: at baseline (before the first intervention), post-treatment (immediately after the 4-week intervention period), and at follow-up (8 weeks after the end of treatment, totaling 3 months of study participation). All evaluations will be performed by a blinded assessor who is unaware of the participants' group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PNE + Spinal Manipulation | Experimental | Behavioral: Pain Neuroscience Education (PNE), Procedure: Spinal Manipulation (SM)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. |
| Spinal Manipulation Alone | Active comparator | Procedure: Spinal Manipulation (SM)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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | PNE + Spinal Manipulation |
| 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. | Procedure or surgery | PNE + Spinal Manipulation, Spinal Manipulation Alone |
Primary outcome
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).
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.
5 secondary outcomes
Change in Pain Intensity
Time frame: Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months).
Change in Functional Disability
Time frame: 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
Time frame: Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months.
Change in Pain Catastrophizing
Time frame: Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months.
Change in Kinesiophobia
Time frame: Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 18225853Oliveira 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.
- Individual participant dataSharing planned: Undecided. The plan to share individual participant data is still under consideration and will be finalized upon study completion, subject to institutional ethical review board guidelines and investigator consensus.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ivan A Barros, Pt, PhD student principal investigator
Augusto Motta University Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education (PNE) and Spinal Manipulation (SM) in people with Low Back Pain, run by Centro Universitário Augusto Motta at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivan A Barros, PT, PhD student (+55 21 98350-0099, ivanbarros.fisio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07639216, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.