Influence of Verbal Suggestion on the Therapeutic Effect of the Joint Manipulation of the Lumbar Spine in Patients with Chronic Non-specific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Numerical Rating Scale (NRS)
研究概览
简要总结
The aim of the study is to evaluate the influence of verbal suggestion on the therapeutic effect of the joint manipulation of the lumbar spine in patients with chronic non-specific low back pain in relation to the pain level, stress, disability, function, sleepiness, tissue temperature and selected blood biochemical markers.
The study participants will be randomly assigned (sealed allocation envelopes) to the following groups:
- Group A (test intervention + placebo communication)
- Group B (test intervention + nocebo communication)
- Group C (test intervention + neutral communication)
The study will mainly consist of the three stages, i.e. before the intervention, immediately after the intervention and 24 hours later.
详细描述
Pain is complex in nature and is closely related to the secretion of biochemical markers such as cortisol, serotonin and oxytocin. Higher levels of inflammatory markers, cytokines and chemokines have been found in patients with low back pain, which ultimately affect the clinical manifestations observed in the patients.
One of the methods of physiotherapeutic treatment of spinal disorders involving manual diagnostic and therapeutic techniques is manual therapy. In the therapy, among others, joint manipulation techniques are used. However, the mechanisms underlying the effects of the joint manipulation on the body have not been fully explained. Undoubtedly, one of the main mechanisms of action of manual therapy is pain modulation.
In recent years, research has been increasingly focusing on manipulation in a psychological context, including mechanisms of fear-avoidance, pain catastrophizing and kinesiophobia. Furthermore, manipulation can affect immune and endocrine system responses.
One of the significant non-specific effects accompanying any medical procedure is a placebo effect. The way health care professionals discuss, describe and inform patients about characteristic symptoms of a given disease its prevention, diagnosis and treatment, influences the patients' feelings and expectations, which in turn affect their psycho-biological reactions, subjective perception and treatment outcomes.
The appropriate choice of words by clinicians influences patients' responses to medical treatments and procedures, whether active or sham. The way in which information about the outcome of a treatment is communicated to patients can induce the reinforcing effects of a given treatment (placebo) or reverse the clinically proven effects of an active treatment, or even increase its adverse outcomes in the form of a nocebo effect.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants will be randomly assigned to groups. One of the researchers will then give the person a verbal message (dependent on the study group). The physiotherapist performing the joint manipulation will not know which study group a given patient belongs to. The researcher collecting results and performing statistical analysis will also be blinded.
入排标准
- 年龄范围
- 19 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants with low back pain lasting more than 3 months,
- •participants who have not been taking any non-steroidal anti-inflammatory drugs (NSAIDs) for at least one week prior to the start of the study,
- •participants who are not taking any steroid drugs,
- •participants who have never had the joint manipulation before,
- •participants within the age range of 19-30 years,
- •written consent to participate in the study.
排除标准
- •participants who are students of physiotherapy,
- •participants with a BMI >33,
- •participants after a lumbar spine surgery,
- •participants who, in the 6 months prior to the start of the study, suffered from a lumbar spine injury,
- •participants with diabetes,
- •participants with rheumatic diseases,
- •participants with endometriosis,
- •participants with endocrine diseases,
- •participants with acute inflammation in the lumbar spine region and sciatica symptoms.
结局指标
主要结局
Numerical Rating Scale (NRS)
时间窗: Before the intervention, immediately after the intervention and 24 hours later
The participant gives a score expressed in numbers from 0 to 10
次要结局
- Back Pain Function Scale (BPFS)(Before the intervention, immediately after the intervention and 24 hours later)
- Serological test - oxytocin(Before the intervention, immediately after the intervention and 24 hours later)
- Roland-Morris Disability Questionnaire (RMDQ)(Before the intervention, immediately after the intervention and 24 hours later)
- Scale for the subjective assessment of the treatment outcomes based on the GRoC methodology(Immediately after the intervention and 24 hours later)
- Perceived Stress Scale (PSS-10)(Before the intervention, immediately after the intervention and 24 hours later)
- Stress Numerical Rating Scale-11(Before the intervention, immediately after the intervention and 24 hours later)
- Tampa Scale of Kinesiophobia (TSK)(Before the intervention, immediately after the intervention and 24 hours later)
- Serological test - cortisol(Before the intervention, immediately after the intervention and 24 hours later)
- The assessment of the pain levels with the Baseline dolorimeter(Before the intervention, immediately after the intervention and 24 hours later)
- Epworth Sleepiness Scale (ESS)(Before the intervention and 24 hours later)
- Serological test - serotonin(Before the intervention, immediately after the intervention and 24 hours later)
- Scale for the subjective assessment of the expectations for the treatment outcomes based on the GRoC methodology(Before the intervention)
- Tests with a thermal imaging camera (FLIR E54, USA)(Before the intervention, immediately after the intervention and 24 hours later)
- Tests with the Medi-Mouse (Switzerland)(Before the intervention, immediately after the intervention and 24 hours later)