Investigation of the Effect of Matrix Rhythm Therapy on Functional Status, Quality of Life, Respiratory Functions and Physical Performance in Axial Spondyloarthritis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
研究概览
简要总结
Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic musculoskeletal disease affecting the axial skeleton. The most prominent symptom in patients with axial spondyloarthritis is morning stiffness and chronic low back pain. This is a chronic inflammatory disease group in which exercise and physiotherapy programs are recommended along with medical treatment. Considering the mechanism of action of matrix rhythm therapy, it was predicted that axial spondyloarthritis patients may show improvement.
详细描述
Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic musculoskeletal disease affecting the axial skeleton. In addition to axial and musculoskeletal manifestations (arthritis, enthesitis, dactylitis), extramusculoskeletal manifestations (acute anterior uveitis, inflammatory bowel disease, psoriasis) are often present. In axSpA, the primary pathophysiology occurs in the entheses, the site of attachment of muscles to bones, and in the subchondral bone. In addition, secondary synovitis accompanies the pathology occurring in the enthesis. Mechanical stresses are very important in the onset and progression of axSpA. Axial inflammation causes bone destruction and plays an important role in the pathophysiology of axSpA.
The most common and frequently occurring symptom of axSpA is chronic (> 3 months) and almost daily chronic low back pain (CLBP) with morning stiffness. Pain and stiffness usually involve the lumbar region and buttocks, but any level of the spine can be affected. In addition, axial inflammation (synovitis and enthesitis) in axSpA causes irreversible structural damage and reduces spinal mobility. Spinal limitation is a late sign of axSpA.
Arthritis and enthesitis are the most common peripheral symptoms in axSpA and occur in approximately 30% of patients. Peripheral arthritis, which presents with edema and pain in the joints, is usually asymmetric monoarthritis/oligoarthritis and usually involves the lower extremities. Peripheral enthesitis usually presents with pain, stiffness and/or tenderness. Frequently, achilles enthesitis is seen in the lower extremities, but as axial enthesitis, it causes chest/back pain with synovitis of the axial joints. The combination of pharmacologic and non-pharmacologic methods in the treatment of axSpA has been shown to provide optimum benefit to patients. Pharmacologically, NSAIDs, tumor necrosis factor inhibitors, interleukin-17 inhibitors and Janus kinase inhibitors are preferred. In non-pharmacologic treatments, physiotherapy and exercise applications are recommended by the International Spondyloarthritis Society (ASAS-EULAR) with evidence grades 1a and 2b, respectively.
Exercise is the gold standard in the management of axSpA due to its proven benefits on disease outcomes independent of pharmacologic treatment. In the literature, studies conducted to evaluate the effects of exercise types (in-water exercises, group exercises, supervised individual exercises, aerobic exercises, pilates, tai-chi exercises, therapeutic exercises, proprioceptive exercises) on axSpA patients are frequently encountered. Due to the chronic nature of axSpA, continuity of treatment and time management, these exercises are modified and usually applied as home-based exercises. Home-based exercises are easily applicable and cost-effective, allowing patients to exercise while continuing their normal lives. In the literature, home-based exercise approaches have been shown to have positive effects on Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), scores, quality of life, pain and functional capacity in axSpA patients.
Exercise helps to regulate circulation, excrete metabolites and increase mitochondrial activity as a result of relaxation and contraction of muscles during activity. Some studies have shown pathological changes in the extracellular matrix of affected tissues in patients with axSpA. Successful treatment should focus on mobility of the extracellular matrix. Matrix metalloproteinase-mediated degradation of type II collagen, the main exacellular protein in cartilage, has been reported to be increased in patients with
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18 years and over
- •Individuals who can understand and respond to assessments
- •Individuals followed with a diagnosis of axial spondyloarthritis for at least 6 months
- •Individuals with a BASDAI score above 4
排除标准
- •Individuals with unstable angina pectoris, uncompensated heart failure, myocardial infarction in the last month, which may pose a risk during exercise practices
- •Individuals with uncontrolled diabetes, hypertension above 180/110 mmHg and/or severe neuropathy
- •Individuals with diagnosed psychiatric illness
- •Individuals with diagnosed severe cognitive impairment
- •Individuals with severe dyspnea, cyanosis, hemoptysis at rest and/or minimal exertion
- •Individuals with previous spinal injury and/or surgery
- •Individuals with Psoriasis, Irritable Bowel Disease
- •Individuals with pregnancy status/suspicion
- •Patients with total ankylosis on direct radiograph or bamboo cane appearance on thoracolumbar radiograph
结局指标
主要结局
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
时间窗: At baseline and after 6 weeks
The BASDAI is a self-administered questionnaire consisting of six questions about the five main symptoms of fatigue, pain/swelling in the spine and joints, localized areas of tenderness and morning stiffness, measuring both severity and duration. Patients are asked to mark the extent to which they have experienced the relevant symptoms during the previous week. The first 5 questions are assessed using a visual analog scale with no markers on either end except for "not at all" and "very severe". For the amount of morning stiffness, the scale is graded in 15 minute intervals between 0-2 hours. The total score is calculated by averaging the total scale scores. A total score above 4 is considered active disease
Bath Ankylosing Spondylitis Metrology Index (BASMI)
时间窗: At baseline and after 6 weeks
BASMI consists of 5 measurements: cervical rotation, tragus-wall distance, lateral flexion, modified schober distance and intermalleolar distance. Each measurement is scored between 0 (mild disease involvement) and 2 (severe disease involvement). Total BASMI score is between 0-10.
Ankylosing Spondylitis Disease Activity Score (ASDAS)
时间窗: At baseline and after 6 weeks
ASDAS was developed in 2009 to assess disease activation. The ASDAS assessment consists of the second, third and sixth questions of the BASDAI, the patient's general self-assessment and the acute phase reactants CRP or ESR variables. The second, third and sixth questions of the BASDI are How would you describe the level of your neck, back, lower back and hip pain, How would you describe the level of your neck, back, lower back and hip pain and How long does your morning stiffness last after waking up? 0.12 x Back pain + 0.06 x Duration of morning stiffness + 0.11 x General assessment of the patient + 0.07 x Peripheral joint swelling/pain + 0.58 x Ln (CRP+1) to obtain the ASDASESH/CRP score and a score above 1.3 is considered active disease.
Sit-Bench Test
时间窗: At baseline and after 6 weeks
Hip and trunk flexibility will be assessed with the Sit-Bench Test. In this test, patients are placed in a long sitting position with their legs straight. The wall of the sit-stand board is placed on the soles of the feet and then the patient is asked to reach forward without bending the legs. After three reaches, the patient waits for two seconds and the distance between the fingertip of the hand and the board resting on the sole of the foot is recorded in +/- centimeters (cm).
Chair Sit Up Test
时间窗: At baseline and after 6 weeks
A simple and quick test commonly used in the clinic to measure functional mobility.For the chair sit up test, the patient will sit in the center of a standard chair with their feet touching the floor. The patient will be asked to sit and stand in this position for 30 seconds without support and the total number of full sit-ups during this time will be recorded. Higher number of repetitions indicates better performance.
Respiratory Muscle Strength
时间窗: At baseline and after 6 weeks
Respiratory muscle strength will be measured using MD Diagnostics Brand RP Check Respiratory Muscle Strength (Mip, Mep, Snip) Meter. Maximum inspiratory intraoral pressure and maximum expiratory intraoral pressure will be recorded.
Pulmonary Function Test (PFT)
时间窗: At baseline and after 6 weeks
Pulmonary Function Test (PFT) is performed with a spirometer to evaluate lung volume and capacity. Lung functions of the patients will be evaluated with a spirometer (Cosmed Pony FX). As a result of the test, forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), FEV1/FVC values will be recorded.
Modified stoke ankylosing spondylitis spinal score (mSASSS)
时间窗: At baseline and after 6 weeks
Cervical and lumbar lateral radiographs, which are routinely ordered during the follow-up of the patients, will be evaluated according to the mSASSS system by the Rheumatology specialist of İzmir Buca Seyfi Demirsoy Training and Research Hospital. According to mSASSS, normal vertebrae are scored as 0, erosion/sclerosis/carring as 1, presence of syndesmophytes as 2, and ankylosis as 3 points. For cervical mSASSS, the upper and lower corners of all vertebrae between the lower corner of the C2 vertebra and the upper corner of the T1 vertebra will be evaluated. For lumbar mSASSS, the upper and lower corners of all vertebrae between the lower corner of the T12 vertebra and the upper corner of the sacrum will be evaluated. At the end of the assessment, the cervical mSASSS score, lumbar mSASSS score and total mSASSS score will be recorded.
Bath Ankylosing Spondylitis Functional Index (BASFI)
时间窗: At baseline and after 6 weeks
BASFI consists of 8 questions about functional activities in the last week and two questions assessing patients' ability to cope with daily life. Each question is answered on a 10 cm horizontal visual analog scale (VAS). There are no markings on the scale other than the words "easy" and "impossible" at both ends of the line to determine the direction of severity. The total score is calculated by averaging the ten questions, with higher scores indicating severe impairment.
Ankylosing Spondylitis Quality of Life Questionnaire (ASYK)
时间窗: At baseline and after 6 weeks
The questionnaire consists of eighteen questions and each question is scored as yes-1 point and no-2 points. The total score ranges from 0-18, with a higher score indicating a worse quality of life.
Chest circumference measurement
时间窗: At baseline and after 6 weeks
Chest circumference measurement will be performed to evaluate chest expansion. In particular, in order to prevent contraction of the latissimus dorsi muscle and the associated misleading increase, the difference between maximum inspiration and expiration will be measured at the level of the 4th intercostal space with the patient's arms flexed in the frontal plane and the hands placed behind the head. A difference of less than 5 cm is considered significant for uptake
6 Minute Walk Test (6MWT)
时间窗: At baseline and after 6 weeks
The 6DYT will be administered indoors in corridor lengths with smooth surfaces, at least 20 meters in length. In the test, with comfortable clothing and shoes suitable for walking, individuals will walk as quickly as possible at their own pace, stopping and using oxygen when necessary. Before and after the test, the heart rate, blood pressure and oxygen saturation (SpO2) of the individual will be measured; the degree of dyspnea according to the Borg scale and quadriceps fatigue will be questioned. At the end of the test, the reason and duration of rest, if any, will be recorded and the individual's six-minute walking distance will be determined in meters.
Timed Get Up and Go (SDG) Test
时间窗: At baseline and after 6 weeks
The SDM is a simple and rapid test widely used in the clinic that measures functional mobility of the lower limb, fall risk and performance. According to test scores \<10sec = mobile, 10-20 s = usually independent \> 30 sec = classified as restricted mobile For the SKY test, subjects will sit upright on a standard stool with their feet on the floor. With the command 'start', the patient will be asked to get up without holding on, walk towards an object 3 meters away, turn around, return to the chair and sit down. The time will start when the command is given and end when the person sits back in the chair. The elapsed time will be recorded with a stopwatch (sec).
次要结局
未报告次要终点
研究者
Ferruh Taşpınar
Study Director
Izmir Democracy University