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临床试验/NCT07639216
NCT07639216尚未招募不适用

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

Centro Universitário Augusto Motta1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2026年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
74
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Clinical outcomes will be evaluated by a blinded assessor who is completely unaware of the participants' group allocation throughout the entire study period.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究者

发起方
Centro Universitário Augusto Motta
申办方类型
Other
责任方
Sponsor

研究点 (1)

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