An interventional study of Pain Neuroscience Education (PNE) and Spinal Manipulation (SM) in Low Back Pain, sponsored by Centro Universitário Augusto Motta. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Centro Universitário Augusto Motta · Not applicable, Interventional, and Treatment
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.
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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 74 is above the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Centro Universitário Augusto Motta is the lead sponsor of 39 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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).
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.
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).
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).
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).
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.
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.
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.
Time frame: Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months.
Plan to share: 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.
Start is estimated for Jul 2026; primary completion for Jul 2027, 12 months later.
Of 1,231 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 12 months is close to that.
Counting every sponsor, half of 1,286 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
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Centro Universitário Augusto Motta