The Effect of Peloidotherapy on Pain and Quality of Life in Young Adult Individuals With Scoliosis Undergoing Physiotherapy Scoliosis-Specific Exercises (PSSE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Adam's Test
研究概览
简要总结
Scoliosis is a musculoskeletal disorder defined by a three-dimensional spinal deformity that can result in substantial clinical and functional limitations, particularly during adolescence and young adulthood. Affected individuals commonly experience postural asymmetry, muscular imbalance, pain, and diminished quality of life. In conservative management, Physiotherapeutic Scoliosis-Specific Exercises (PSSE) have gained recognition as a fundamental intervention. The primary objectives of PSSE include optimizing spinal alignment, facilitating rotational breathing, and restoring muscular symmetry to improve functional capacity. Evidence from systematic reviews suggests that PSSE, especially the Schroth method, are superior to general exercise programs in improving both radiographic parameters and health-related quality of life.Meta-analytic findings further support the effectiveness of PSSE in reducing curve magnitude and enhancing quality of life outcomes. Among the various PSSE approaches, the Schroth method is one of the most extensively investigated and widely applied in clinical settings. This method incorporates three-dimensional postural correction, targeted breathing techniques, and the development of postural awareness. Randomized controlled trials have demonstrated that Schroth exercises significantly improve SRS-22 quality of life scores and positively influence pain, body image, and overall well-being.Despite these established benefits, pain and muscle tension occurring during exercise sessions may negatively influence adherence to rehabilitation programs. In young adults, pain is a critical factor limiting treatment compliance and restricting engagement in daily activities. Accordingly, adjunctive interventions implemented prior to exercise may enhance exercise tolerance and optimize therapeutic outcomes.Peloidotherapy, which involves the therapeutic application of natural medicinal mud, is commonly used in musculoskeletal rehabilitation due to its analgesic, muscle-relaxant, and circulation-enhancing effects. By alleviating pain and reducing muscular tension, peloidotherapy may facilitate greater participation in exercise programs and support improved clinical outcomes.This study aims to investigate the effects of adjunctive peloidotherapy administered before Schroth-based PSSE in young adults with scoliosis, focusing on pain, exercise adherence, and quality of life, with particular emphasis on SRS-22 measures..
详细描述
Scoliosis is a musculoskeletal disorder characterized by a three-dimensional spinal deformity that can cause clinical and functional problems, particularly during adolescence and young adulthood. Postural abnormalities, muscle imbalances, pain, and decreased quality of life are frequently reported in individuals with scoliosis.Non-surgical conservative approaches are of great importance, especially in mild to moderate curvatures, to control the progression of the deformity, increase functional capacity, and reduce symptoms.
In recent years, scoliosis-specific physiotherapy exercises (Physiotherapeutic Scoliosis-Specific Exercises - PSSE) have been accepted as an indispensable part of conservative treatment. PSSE are exercises designed for the three-dimensional nature of spinal curvature and are planned specifically for the patient's curvature pattern. These exercises aim to increase the functional capacity of the spine by targeting correct posture, rotational breathing, and muscle balance. Systematic reviews have shown that PSSE, particularly the Schroth approach, is more effective than other types of exercise in improving quality of life and curvature parameters.
In particular, meta-analyses have indicated that PSSE provides relative improvements in quality of life and degree of curvature. Schroth exercises are one of the most studied and widely used methods in clinical practice for PSSE. The Schroth method involves three-dimensional postural correction, rotational breathing techniques, and increased postural awareness. Controlled randomized studies have reported that Schroth exercises provide significant improvements in SRS-22 quality of life scores and have positive effects on pain, body awareness, and quality of life parameters.
Although PSSE Schroth exercises have been shown to have positive effects on quality of life and curvature parameters in individuals with scoliosis, pain and muscle tension that arise during the exercise process can negatively affect individuals' adherence to the exercise program. The presence of pain is a significant factor limiting treatment compliance and daily living activities, especially in young adults. At this point, complementary treatment methods that can be applied before exercise have the potential to increase treatment effectiveness.
Peloidotherapy is a physical therapy method involving the application of natural therapeutic mud and is used for musculoskeletal disorders due to its pain-relieving, muscle-relaxing, and circulation-enhancing effects. These therapeutic applications have potential benefits in increasing exercise tolerance and improving quality of life. However, there are a limited number of studies on the effectiveness of peloidotherapy when combined with PSSE programs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20-40 years
- •Diagnosed with idiopathic scoliosis by a specialist physician
- •Cobb angle between 15-40 degrees
- •Able to perform PSSE exercises throughout the study period
- •VAS ≥3 at the start of the study
- •Has had pain complaints for at least 3 months
- •Individuals who have agreed in writing to participate in the study
排除标准
- •Individuals who have undergone scoliosis surgery
- •Individuals with neuromuscular, congenital, or secondary scoliosis
- •Individuals with rheumatological, inflammatory, or serious chronic diseases (such as cardiopulmonary insufficiency or kidney disease)
- •Pregnant and breastfeeding women
- •Conditions in which peloidotherapy is contraindicated (active skin infection, open wound, serious dermatological disease, history of allergic reaction, severe cardiopulmonary, kidney or liver failure, bleeding disorder or anticoagulant use, pregnancy/breastfeeding, and systemic infection)
- •Individuals with serious psychiatric disorders that may interfere with treatment compliance or affect consent
- •Individuals receiving additional physical therapy during the study period
研究组 & 干预措施
Study Group
Patients diagnosed with scoliosis deformity beginning in adulthood between the ages of 20 and 40 The scoliosis study form, consisting of clinical and radiological measurements of patients between the ages of 20 and 40 who have been diagnosed with scoliosis beginning in adulthood and who have applied to the scoliosis clinic, will be filled out in detail. Individuals included in the study group through randomization will receive both peloidotherapy and PSSE.
干预措施: Adult Scoliosis Study Form (Diagnostic Test)
Control group
Patients diagnosed with scoliosis deformity beginning in adulthood between the ages of 20 and 40 The scoliosis study form, consisting of clinical and radiological measurements of patients between the ages of 20 and 40 who have been diagnosed with scoliosis beginning in adulthood and who have applied to the scoliosis clinic, will be filled out in detail. Individuals included in the control group through randomization will only receive PSSE.
干预措施: Scoliosis graphy (Diagnostic Test)
Study Group
Patients diagnosed with scoliosis deformity beginning in adulthood between the ages of 20 and 40 The scoliosis study form, consisting of clinical and radiological measurements of patients between the ages of 20 and 40 who have been diagnosed with scoliosis beginning in adulthood and who have applied to the scoliosis clinic, will be filled out in detail. Individuals included in the study group through randomization will receive both peloidotherapy and PSSE.
干预措施: Scoliosis graphy (Diagnostic Test)
Study Group
Patients diagnosed with scoliosis deformity beginning in adulthood between the ages of 20 and 40 The scoliosis study form, consisting of clinical and radiological measurements of patients between the ages of 20 and 40 who have been diagnosed with scoliosis beginning in adulthood and who have applied to the scoliosis clinic, will be filled out in detail. Individuals included in the study group through randomization will receive both peloidotherapy and PSSE.
干预措施: Visuel Aanalog Scale (Diagnostic Test)
Study Group
Patients diagnosed with scoliosis deformity beginning in adulthood between the ages of 20 and 40 The scoliosis study form, consisting of clinical and radiological measurements of patients between the ages of 20 and 40 who have been diagnosed with scoliosis beginning in adulthood and who have applied to the scoliosis clinic, will be filled out in detail. Individuals included in the study group through randomization will receive both peloidotherapy and PSSE.
干预措施: Adam's Test (Diagnostic Test)
Study Group
Patients diagnosed with scoliosis deformity beginning in adulthood between the ages of 20 and 40 The scoliosis study form, consisting of clinical and radiological measurements of patients between the ages of 20 and 40 who have been diagnosed with scoliosis beginning in adulthood and who have applied to the scoliosis clinic, will be filled out in detail. Individuals included in the study group through randomization will receive both peloidotherapy and PSSE.
干预措施: TRACE (Trunk Aesthetic Clinical Evaluation) (Other)
Control group
Patients diagnosed with scoliosis deformity beginning in adulthood between the ages of 20 and 40 The scoliosis study form, consisting of clinical and radiological measurements of patients between the ages of 20 and 40 who have been diagnosed with scoliosis beginning in adulthood and who have applied to the scoliosis clinic, will be filled out in detail. Individuals included in the control group through randomization will only receive PSSE.
干预措施: Adult Scoliosis Study Form (Diagnostic Test)
Control group
Patients diagnosed with scoliosis deformity beginning in adulthood between the ages of 20 and 40 The scoliosis study form, consisting of clinical and radiological measurements of patients between the ages of 20 and 40 who have been diagnosed with scoliosis beginning in adulthood and who have applied to the scoliosis clinic, will be filled out in detail. Individuals included in the control group through randomization will only receive PSSE.
干预措施: Visuel Aanalog Scale (Diagnostic Test)
Control group
Patients diagnosed with scoliosis deformity beginning in adulthood between the ages of 20 and 40 The scoliosis study form, consisting of clinical and radiological measurements of patients between the ages of 20 and 40 who have been diagnosed with scoliosis beginning in adulthood and who have applied to the scoliosis clinic, will be filled out in detail. Individuals included in the control group through randomization will only receive PSSE.
干预措施: Adam's Test (Diagnostic Test)
Control group
Patients diagnosed with scoliosis deformity beginning in adulthood between the ages of 20 and 40 The scoliosis study form, consisting of clinical and radiological measurements of patients between the ages of 20 and 40 who have been diagnosed with scoliosis beginning in adulthood and who have applied to the scoliosis clinic, will be filled out in detail. Individuals included in the control group through randomization will only receive PSSE.
干预措施: TRACE (Trunk Aesthetic Clinical Evaluation) (Other)
结局指标
主要结局
Adam's Test
时间窗: At the beginning (pre-treatment), at the end of the 10-session PSSE treatment (post-treatment), one month after the start of treatment, and three months after the start of treatment
The Adams test (forward bending test) (+) will be measured by Bunnell scoliometer (scoliosis assessment tool) and ATR (angle of trunk rotation- trunk rotation) measurements. Trunk rotation is a common component of scoliosis. It adds a twisting motion to the curvature of the spine. You can think of it like a spiral staircase turning upward. In scoliosis, the apical vertebra and vertebrae, which are the bones of the spine, can also twist, causing the ribs to twist with them. This bending is measured by the trunk rotation angle (trunk rotation angle or ATR). A higher ATR means that the bending of the body is more pronounced. The Cobb angle can be estimated using scoliometer measurements of the trunk rotation angle (ATR).
Visuel Aanalog Scale
时间窗: At the beginning (pre-treatment), at the end of the 10-session PSSE treatment (post-treatment), one month after the start of treatment, and three months after the start of treatment
Pain in adults with scoliosis will be assessed and recorded using the visual analog scale. Adults with scoliosis who report pain above VAS\>3 will be included in the assessment. The Visual Analog Scale (VAS) is a subjective pain measurement tool where patients indicate the intensity of their pain by marking a point on a 10 cm (100 mm) horizontal line. The beginning of the line represents "no pain," and the end represents "the most severe pain imaginable." The marked point is measured between 0-10 cm (or 0-100 mm) and converted into a score, and is widely used in clinical pain assessment.
TRACE (Trunk Aesthetic Clinical Evaluation)
时间窗: At the beginning (pre-treatment), at the end of the 10-session PSSE treatment (post-treatment), one month after the start of treatment, and three months after the start of treatment
Aesthetic appearance is a primary consideration in the treatment of scoliosis. This has been clearly stated in a consensus by SOSORT experts, in which aesthetic improvement has become the main goal of scoliosis treatment.TRACE is based on four sub-scales: shoulders, scapulae and waist (which were already present in the AI), and the hemithorax. However, the scores for each sub-scale were changed with respect to AI: shoulders now ranged from 0-3, waist from 0-4, scapulae from 0-2 and hemithorax from 0-2. From these sub-scales we calculated TRACE, using the sum of the sub-scale scores to reach a 12-point scale
SRS-22r (Scoliosis Research Society Score)
时间窗: At the beginning (pre-treatment), at the end of the 10-session PSSE treatment (post-treatment), one month after the start of treatment, and three months after the start of treatment
The SRS-22r is a validated questionnaire intended to assess outcomes in patients with idiopathic scoliosis after spinal surgery. The first version, developed by the Scoliosis Research Society in 1999, had 24 items, and this was reduced to 22 items (accompanied by a name change) in the course of 3 major updates.The SRS-22 contains 22 questions covering 5 domains: function/activity 5 items; pain 5 items; self-perceived image 5 items; mental health 5 items; and satisfaction with treatment 2 items. Each item is scored from 1 (worst) to 5 (best). Each domain has a total sum score ranging from 5 to 25, except for satisfaction, which ranges from 2 to 10. The sum of the first 4 domains gives a maximum subtotal of 100, and when the satisfaction domain is included, the maximum total is 110
次要结局
- Questionnaire of Physiotherapeutic Specific Exercises of Scoliosis-QPSSE(At the end of the 10-session PSSE treatment (post-treatment), one month after the start of treatment, and three months after the start of treatment)
- Beck Depression Inventory(At the beginning (pre-treatment), at the end of the 10-session PSSE treatment (post-treatment), one month after the start of treatment, and three months after the start of treatment)