Pain Experience in Individuals With Chronic Low Back Pain: a Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Self-management
研究概览
简要总结
Low back pain is a very common musculoskeletal condition that affects many people each year regardless of age, gender, and ethnicity. Most people get better however, some continue suffering from painful episodes despite treatment.
Self-management strategies for the management of chronic low back pain are very important to patients as they help them develop skills to manage their pain more effectively. However, self-management strategies are not always effective as expected. It is possible that the brain has become very sensitive to signals coming from peripheral parts of the body (e.g. low back) affecting the ability of patients to self-manage their condition.
The aim of this study is to establish whether central sensitisation (sensitivity of the brain to peripheral signals) predicts how effective self-management approaches will be.
On three different occasions, scheduled sessions will include a clinical assessment session and completion of a questionnaire booklet. The clinical assessment will measure three features of central sensitisation: 1) sensitivity to blunt pressure on the forearm, 2) changes in pain, felt during repeated light pricking of the forearm skin, and 3) reduction in pain that accompanies inflation of a blood pressure cuff on the opposite arm. Participant involvement at each session is expected to last for 70 minutes.
Individuals over 18, diagnosed with chronic low back pain and enlisted to follow a pain management program are eligible to participate. The clinical assessments, questionnaire completion and subsequent statistical analysis are expected to be completed within 18 months of study commencement.
Based on our findings, future research may use similar clinical assessment to identify people who might be helped to self-manage by using treatment that reduces central sensitisation.
详细描述
Low Back Pain (LBP) is considered a common condition consisting of a set of complains (pain, muscle tension, or stiffness), manifesting primarily to the lower back region (below the costal margin and above the inferior gluteal folds). LBP may or may not include radiating pain to the lower limb and can be caused by a number of underlying pathologies with varying levels of severity [1]. The condition can be the result of complex interactions between multiple physical and psychological factors including osteoarthritis (OA), degenerated discs, disc herniation, muscle dysfunction, obesity, poor posture, mental illness, negative affect (stress, anxiety, depression) [2].
LBP lifespan incidence appears to be 58-84% while it is estimated that 11% of males and 16% of females suffer from chronic LBP at any point in time [3]. It is expected that 40-50% of individuals suffering from acute LBP will continue to experience pain at three months and will demonstrate little or none further improvement, while 60-70% of those who improve will relapse within a year [4]. The global prevalence of LBP demonstrates continuously growing trends with a 17.3% increase in the last 10 years [5].
Self-management (SM) support is a portfolio of techniques and tools to help patients choose healthy behaviours as well as a fundamental transformation of the patient-caregiver relationship into a collaborative partnership [6]. Self-management support has to incorporate in its approach elements that aim to increase patients' self-efficacy, develop problem-solving, decision-making and goal-setting skills as well as to promote partner-like behaviour between patients and health professionals [7]. SM interventions pose as ideal rehabilitation strategies for chronic low back pain (CLBP) as they aim to address biological (neurophysiological, deconditioning, lifestyle) and psychosocial (self-efficacy, maladaptive beliefs, anxiety/depression) factors that have been identified as risk factors for poor outcome [8, 9] and are negatively affected by central sensitisation (CS) [10]. SM interventions are designed to be cost-effective by reducing health care utilisation associated with LBP [11].
Self-management programs (SMP) for CLBP demonstrate only small to moderate effects for long-term improvements in pain and disability. Currently, it is not known what factors predict effective self-management. Evidence of CS varies between individuals with chronic pain, and may contribute to the relatively poor efficacy of SMPs.
CS is a marker of widespread and centrally augmented pain that refers to those neurophysiological processes that can occur throughout the central nervous system (CNS) distribution, leading to changes in the spinal cord as well as in the brain [12]. The presence of CS increases the complexity of the clinical picture [13] and negatively affects a range of outcomes (e.g. pain, disability, negative affect, quality of life) following treatment [14]. CS is not present within all patients with chronic pain [15] rendering identification of those patients and decision-making for the right management approach even harder [16]. Patients with potential development of CS should receive treatment that address the full biopsychosocial clinical spectrum consisting of cognitive behavioural therapy (CBT) as well as therapeutic pain neuroscience education [17]. Changes in pain mechanisms may explain the moderate levels of evidence for the effectiveness of self-management (SM) interventions in LBP populations [7] as CS has been shown to negatively affect the perception of back pain, pain-related disability and lead to poor physical and mental health-related quality of life as well as to greater levels of depression and anxiety [10].
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have the ability to give informed consent.
- •be 18 years old or over
- •be diagnosed with chronic LBP
- •be enlisted for participation in a self-management program
- •be able to speak and understand English as all questionnaires are validated in the English language.
排除标准
- •Inability to give informed consent due to cognitive impairment or otherwise
- •Inability to understand key aspects of the study due to cognitive impairment or otherwise
- •Patients giving history of additional co-morbidities such as cancer, diabetic neuropathies, fractures or other conditions causing greater disability than their back pain.
- •Pregnancy
结局指标
主要结局
Self-management
时间窗: 3 months
Self-management will be assessed with the Health Education Impact Questionnaire (heiQ) that measures the ability of a patient to self-manage their condition and features 40 questions that spread across 8 distinct domains (Health Directed Behavior: 4 items; Positive and Active Engagement in Life: 5 items; Self-Monitoring and Insight: 6 items; Constructive Attitudes and Approaches: 5 items; Skill and Technique Acquisition: 4 items; Social Integration and Support: 5 items Health Service Navigation: 5 items; and Emotional Wellbeing: 6 items). Each item is rated with a 4-level scale (Strongly agree to Strongly disagree) and a number (1-4) is allocated that leads to the calculation of a mean. No single value can be produced for heiQ. Rather, each domain must be used individually. The higher the value the best the self-management ability in all domains apart from Emotional Wellbeing where a high value represents a low self-management ability.
次要结局
- Pain Severity: Numerical Rating Scale (NRS)(3 months)
- Levels of Disability(3 months)
- Patient Quality of Life: EQ-5D-5L questionnaire(3 months)
- Self-efficacy: Pain Self-efficacy Questionnaire (PSEQ)(3 months)
- Fatigue(3 months)
- Anxiety(3 months)
- Depression(3 months)
- Catastrophization(3 months)
- Kinesiophobia(3 months)
- Neuropathic Pain: Pain-DETECT questionnaire (PD-Q)(3 months)
- Widespread Pain(3 months)
- Fibromyalgia Severity(3 months)
- Health care utilisation(3 months)
- Medication type utilisation(3 months)