Low Back Pain
Conditions
Keywords
internal-external control, low back pain, spinal manipulation, pain education
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.
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.
Interventions
BEHAVIORALPain 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).
PROCEDURESpinal 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.
Sponsors
Centro Universitário Augusto Motta
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinical outcomes will be evaluated by a blinded assessor who is completely unaware of the participants' group allocation throughout the entire study period.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health Locus of Control | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity | Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months). | 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. |
| Change in Functional Disability | Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months). | 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. |
| 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. | 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. |
| Change in Pain Catastrophizing | Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months. | 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. |
| Change in Kinesiophobia | Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months. | 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. |
Countries
Brazil
Contacts
CONTACTIvan A Barros, PT, PhD student
CONTACTLuciana C Lunkes, PT, PhD
PRINCIPAL_INVESTIGATORIvan A Barros, Pt, PhD student
Augusto Motta University Center
Outcome results
None listed