Efficacy of Pain Neuroscience Education and Physiotherapy in Patients Diagnosed with Spondyloarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Bath Ankylosing Spondylitis Motility Index (BASMI)
研究概览
简要总结
Spondyloarthritis, notably ankylosing spondylitis (AS), represents a chronic rheumatic condition typified by persistent back pain and stiffness. It constitutes a substantial portion of diagnoses within rheumatology units and exhibits a higher prevalence among males. Diagnosis relies upon comprehensive clinical evaluation, including patient history, physical examination, and adjunctive radiological assessments, with genetic predisposition, particularly the presence of the HLA-B27 antigen, playing a significant role.
Management strategies encompass a multidisciplinary approach, with physiotherapy emerging as a cornerstone therapeutic modality. Various exercise interventions, particularly those supervised by trained professionals, demonstrate efficacy in improving pain, stiffness, and overall functional capacity. Furthermore, patient education plays a pivotal role in enhancing treatment adherence and optimizing outcomes by aligning patient expectations with therapeutic goals.
The evolving landscape of spondyloarthritis management underscores the necessity of further research into multimodal treatment approaches, particularly in integrating novel interventions such as electrophysical agents. By elucidating the mechanisms of action and exploring their synergistic effects, clinicians can refine treatment protocols and ultimately enhance the quality of care provided to individuals living with spondyloarthritis.
详细描述
Spondyloarthritis or ankylosing spondylitis (AS) is a type of chronic spondyloarthropathy. According to the Spanish Society of Rheumatology (SER), spondyloarthropathies constitute a heterogeneous family of interrelated rheumatic diseases that share clinical, pathogenic, genetic, radiological, epidemiological and therapeutic response characteristics. From an epidemiological point of view, they are increasingly frequent diseases, accounting for more than 13% of patients diagnosed in rheumatology units. Specifically, international reference studies place AD as the most frequent, with an estimated incidence of 7 new cases per 100,000 inhabitants per year. It is more frequent in men than in women (in a ratio of 3:1) and the age range is between 20 and 30 years. In Extremadura the incidence is no less. According to the National Institute of Statistics (INE), there are currently 24 cases per 1000 people diagnosed with rheumatoid arthritis or AD, and 55 cases per 1000 people diagnosed with arthritis.
In terms of clinical manifestations, early symptoms include back pain and stiffness. Over time, AS can fuse vertebrae and limit movement, causing severe and constant pain. Diagnosis and follow-up of the disease is based on clinical history and physical examination. Radiological tests may also be used to complement the diagnosis. Over the years, the concept of spondyloarthropathy has evolved, and is now defined as a combination of axial spondyloarthritis (SpA), psoriatic arthritis (PsA) and inflammatory bowel disease (IBD).
With regard to the criteria according to the Assessment of Spondyloarthritis International Society (ASAS) and the latest update of the Clinical Practice Guideline for the treatment of SpA and psoriatic arthritis, within SpA the investigators find AD as the most representative pathology of this group, being the one the investigators will focus on in this research project.
The diagnosis of axial SpA requires: a) imaging evidence confirming sacroiliitis and b) at least one sign of SpA or HLA-B27 marker and two of the signs determined according to ASAS (inflammatory low back pain, arthritis, enthesitis, uveitis, dactylitis, psoriasis, Crohn's disease, good response to NSAIDs, family history of SpA, presence of HLA-B27 antigen or presence of increased C-reactive protein). In this regard, in addition to imaging and laboratory tests, the International Society for the Evaluation of SpA classification considers common clinical features as the main diagnostic axis.
Based on the latest SER review, the mechanism by which the disease occurs is still not entirely clear, although there is a genetic predisposition. Among the factors involved, the most important is the presence of the positive HLA-B27 antigen, which is present in the vast majority of patients with AD and less frequently in the rest of the diseases of the SpA group. Taking into account that only 10% of HLA-B27 antigen carriers will present with the disease, it is essential to present clinical signs to support the diagnosis.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (men and women) over 18-65 years of age.
- •Diagnosed with ankylosing spondylitis by a rheumatologist.
排除标准
- •Sample subjects with spinal surgery in the last 12 months were excluded.
- •Subjects with mild/moderate cognitive impairment (score ≥24 in the Spanish validated version for general older adults of the Mini-Mental State Examination) (Lobo A, Saz P, Marcos G et al. Revalidation and standardisation .
- •Finally, those with pharmacological treatment that could generate vestibular or balance disturbances at the time of assessment and treatment.
结局指标
主要结局
Bath Ankylosing Spondylitis Motility Index (BASMI)
时间窗: 4 weeks.
The Bath Ankylosing Spondylitis Motility Index (BASMI) explores the mobility of the spine and hips and includes the Schober test to indicate the degree of mobility of the lumbar tract. The minimum score is 0 and the maximum score is 10. Higher scores indicate a worse outcome.
Pressure Pain Threshold (PPT)
时间窗: 4 weeks.
A mechanical pressure Fisher algometer (Force Dial model FDK 40) with a 1 cm² area contact head was used to measure the pressure pain threshold. The reliability of pressure algometry has been found to be high \[intraclass correlation coefficient = 0.91 (95% confidence interval, 0.82-0.97)\]. With the participant in supine, the pressure pain threshold of the the myofascial trigger point nº2 of the upper trapezius muscle according to Travell and Simons and the central trigger point of the sternocleidomastoid muscle was bilaterally evaluated. Also, in sitting position the pressure pain threshold of the myofascial trigger point of the scapula elevator muscle was bilaterally evaluated. The minimal clinically important difference (MCDI) is 1.2 Kg/cm2.
Kinesophobia
时间窗: 4 weeks.
The Spanish version of the TSK-11 was used to measure fear of movement. Higher scores indicate greater fear-avoidance behaviors. The TSK-11 has demonstrated acceptable internal consistency and validity.
Numeric Pain Rating Scale (NPRS)
时间窗: 4 weeks.
Numeric Pain Rating Scale (NPRS) is a 11-point numeric rating scale, where 0 denotes "no pain" and 10 denotes "the maximum bearable pain". The minimum clinically important difference (MCID) for this tool has been established at 1.5 points and the minimum detectable change (MDC) at 2.6 points, in individuals with neck pain. The NPRS is a valid scale with moderate test-retest reliability in this population (Intraclass Coefficient Correlation (ICC): 0.76, 95% CI 0.58 to 0.93).
Cervical and Lumbar Joint Position Sense Error
时间窗: 4 weeks.
This test consists of a visual measurement of the error when moving the head to the initial neutral position after active cervical rotation, or when performing lumbar flexion or extension and returning to a neutral position.
Cervical Range of Motion (CRoM)
时间窗: 4 weeks.
For the evaluation of CROM, a conventional EnrafNonius® two-branch goniometer was used. Subjects were placed in a seated position on a stool, with a neutral neck and head position. The range of active cervical mobility presented by the patients was measured in reference to the three planes of the space. In the sagittal plane, the degrees of mobility to flexion and extension were measured, in the frontal plane the right and left inclinations, and in the transverse plane both rotations.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
时间窗: 4 weeks.
Is a questionnaire used to assess disease activity and severity in individuals with ankylosing spondylitis, focusing on symptoms such as pain, stiffness, and fatigue. The minimum score is 0 and the maximum score is 60. Higher scores indicate a worse outcome.
Bath Ankylosing Spondylitis Functional Index (BASFI).
时间窗: 4 weeks.
The Bath Ankylosing Spondylitis Functional Index (BASFI) is a questionnaire used to evaluate the functional ability and physical functioning of individuals with ankylosing spondylitis. It assesses aspects such as activities of daily living, mobility, and overall function, providing a measure of disease impact on a person's life. The minimum score is 0 and the maximum score is 100. Higher scores indicate a worse outcome.
Catastrophizing Pain
时间窗: 4 weeks.
The Pain Catastrophizing Scale (PCS) is a self-administered scale of 13 items and one of the most used to assess catastrophism of pain. The subjects take their past painful experiences as a reference and indicate the degree to which they experienced each of the 13 thoughts or feelings on a 5-point Líkert scale ranging from 0 (never) to 4 (always). The theoretical range of the instrument is between 13 and 62, indicating low scores, little catastrophism, and high values, high catastrophism.
Fear-Avoidance Beliefs Questionnaire (FABQ)
时间窗: 4 weeks.
The Fear-Avoidance Beliefs Questionnaire (FABQ) is a self-report measure designed to assess beliefs and attitudes related to fear of movement and avoidance behavior in individuals with musculoskeletal pain, particularly low back pain. It evaluates the extent to which individuals perceive physical activity as harmful and the degree to which they avoid certain activities due to fear of exacerbating their pain. The minimum score is 0 and the maximum score is 96. Higher scores indicate a worse outcome.
次要结局
未报告次要终点
研究者
Carlos Fernández-Morales
Clinical Professor
Universidad de Extremadura