Neuroscience Education and Spinal Manipulation on Health Locus of Control in Low Back Pain

Официальное название

Pain Neuroscience Education Associated With Spinal Manipulation on Shifting Health Locus of Control in Patients With Low Back Pain: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 n
• Процедура 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.

Первичные конечные точки

• Change in Health Locus of Control [Срок оценки: Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months).]

Вторичные конечные точки (5)

• Change in Pain Intensity [Срок оценки: Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months).]
• Change in Functional Disability [Срок оценки: 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 [Срок оценки: Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months.]
• Change in Pain Catastrophizing [Срок оценки: Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months.]
• Change in Kinesiophobia [Срок оценки: Baseline (pre-intervention), post-treatment (4 weeks), and follow-up (8 weeks after the end of treatment, totaling 3 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Chiropractic Outpatient Clinic, Faculdades Reunidas da ASCE — Rio de Janeiro

Публикации

• 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. PMID 18225853

Идентификаторы

NCT: NCT07639216 · CAAE: 92856425.6.0000.5235

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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