About this trial
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..
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
This study aims to investigate the effects of peloidotherapy combined with a Physiotherapeutic Scoliosis-Specific Exercise (PSSE) program on pain intensity, quality of life, and exercise adherence in patients with idiopathic scoliosis followed at the Scoliosis Clinic of the Department of Physical Medicine and Rehabilitation, Gaziosmanpaşa Training and Research Hospital. Patients scheduled for Barcelona Schroth-based PSSE will be recruited. Demographic data will be recorded. Participants will be randomized into study and control groups using the envelope method. Individuals aged 20-40 years, with a baseline VAS score ≥3 and pain lasting longer than three months, will be included. The study will be single-blinded, and outcomes will be assessed by a blinded evaluator.
Trial design
Case-control
Prospective
Treatments tested in this trial
Adult Scoliosis Study Form
Diagnostic testThe adult scoliosis form, which includes demographic data, clinical and radiological measurements of patients aged 20-40 who present to the outpatient clinic with adult scoliosis, will be completed in detail.
Scoliosis graphy
Diagnostic testPatients with results from the forward bending test and clinical evaluation consistent with scoliosis must have had a scoliosis X-ray taken within the last year. Coronal and sagittal balance; coronal and sagittal Cobb angles will be measured from posterior-anterior (PA) and lateral scoliosis radiographs.
Visuel Aanalog Scale
Diagnostic testPain 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.
Adam's Test
Diagnostic testThe 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).
TRACE (Trunk Aesthetic Clinical Evaluation)
Other interventionAesthetic 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
Treatment groups
Trial outcomes
Primary outcomes
Adam's Test
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
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)
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)
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
Secondary outcomes
Questionnaire of Physiotherapeutic Specific Exercises of Scoliosis-QPSSE
The application of Physiotherapeutic Specific Exercises for Scoliosis (PSEE) alone or with bracing is currently one of the therapeutic models for mild and moderate IS (Idıopathic Scoliosis). The questionnaire consists of 53 questions and eight domains. The eight domains of the final questionnaire were as follows: (1) physical functioning, (2) self-image, (3) Physiotherapeutic Scoliosis-Specific Exercises (PSSEs), (4) psychosocial functioning, (5) cognitive functioning, (6) compliance, (7) motivation, and (8) pain. There are 37 with positive meaning and 15 with negative meaning and 1 multiple choice question. Furthermore, 6 open-ended questions were included related to the PSSEs and the questionnaire. In the scored items, a Likert scale of 1 -5 was used. More specifically, responses 1-5 correspond to 5 = Strongly agree and 1 = Strongly disagree. An additional edit was made to the wording of the questions so that they could correspond meaningfully to these responses.
Beck Depression Inventory
The Beck Depression Inventory (BDI) is a 21-item, self-rated scale that evaluates key symptoms of depression including mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, suicidal ideas, crying, irritability, social withdrawal, indecisiveness, body image change, work difficulty, insomnia, fatigability, loss of appetite, weight loss, somatic preoccupation, and loss of libido. Individual scale items are scored on a 4-point continuum (0=least, 3=most), with a total summed score range of 0-63. Higher scores indicate greater depressive severity
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