Neuroscience Education and Spinal Manipulation on Health Locus of Control in Low Back Pain (NCT07639216) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Neuroscience Education and Spinal Manipulation on Health Locus of Control in Low Back Pain
Brazil74 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Health Locus of Control
Timeframe: Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months).