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| Name | Class |
|---|---|
| Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Ivan A Barros, Pt, PhD student | Augusto Motta University Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiropractic Outpatient Clinic, Faculdades Reunidas da ASCE | Rio de Janeiro | Rio de Janeiro | 21050-660 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18225853 | Background | 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. |
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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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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D020393 | Manipulation, Spinal |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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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.
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Clinical outcomes will be evaluated by a blinded assessor who is completely unaware of the participants' group allocation throughout the entire study period.
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| 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. |
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| 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. | 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. | 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. | 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. | Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |