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Идёт набор NCT07459400

The Effect of Peloidotherapy in Young Adults Undergoing Physical Therapy Scoliosis Specific Exercises (PSSE)

Наблюдательное Spine Deformity Adult Scoliosis Peloidotherapy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Adult Scoliosis Study Form, Scoliosis graphy, Visuel Aanalog Scale, Adam's Test.
Кому может быть актуально
Состояния в реестре: Spine Deformity, Adult Scoliosis, Peloidotherapy. Базовые параметры: 20 лет — 40 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effect of Peloidotherapy on Pain and Quality of Life in Young Adult Individuals With Scoliosis Undergoing Physiotherapy Scoliosis-Specific Exercises (PSSE)

Обзор

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..

Подробное описание

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.

The rationale for this study is to scientifically evaluate the effect of peloidotherapy, applied additionally before exercise in young adult individuals with scoliosis undergoing the PSSE Schroth exercise program, on pain, exercise compliance, and quality of life (particularly SRS-22).

While the literature supports the positive effects of Schroth exercises on quality of life, the potential benefits of these effects in combination therapies have not yet been sufficiently investigated. The findings are expected to provide innovative contributions to conservative scoliosis treatment protocols and shed light on the development of multidisciplinary approaches in clinical practice.

Вмешательства

  • Диагностический тест Adult Scoliosis Study Form
    The 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.
  • Диагностический тест Scoliosis graphy
    Patients 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.
  • Диагностический тест 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.
  • Диагностический тест 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 measur
  • Другое 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 fr

Первичные конечные точки

  • Adam's Test [Срок оценки: 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]
  • Visuel Aanalog Scale [Срок оценки: 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]
  • TRACE (Trunk Aesthetic Clinical Evaluation) [Срок оценки: 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]
  • SRS-22r (Scoliosis Research Society Score) [Срок оценки: 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]
Вторичные конечные точки (2)
  • Questionnaire of Physiotherapeutic Specific Exercises of Scoliosis-QPSSE [Срок оценки: 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 [Срок оценки: 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]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр
  • Gaziosmanpasa Training and Research Hospital — Istanbul

Публикации

  • Jia K, Yang Y. Effect of acupuncture and massage on adolescent idiopathic scoliosis and pain severity. Front Med (Lausanne). 2025 Jul 21;12:1613800. doi: 10.3389/fmed.2025.1613800. eCollection 2025. PMID 40761866
  • Karaarslan F, Yilmaz H, Akkurt HE, Gul S, Kardes S. Effectiveness of peloid therapy in patients with chronic low back pain: a single-blind controlled study. Int J Biometeorol. 2021 Nov;65(11):1799-1809. doi: 10.1007/s00484-021-02137-6. Epub 2021 May 1. PMID 33931829
  • Schreiber S, Parent EC, Moez EK, Hedden DM, Hill D, Moreau MJ, Lou E, Watkins EM, Southon SC. The effect of Schroth exercises added to the standard of care on the quality of life and muscle endurance in adolescents with idiopathic scoliosis-an assessor and statistician blinded randomized controlled trial: "SOSORT 2015 Award Winner". Scoliosis. 2015 Sep 18;10:24. doi: 10.1186/s13013-015-0048-5. eCo PMID 26413145
  • Kyrkousis A, Iakovidis P, Chatziprodromidou IP, Lytras D, Kasimis K, Apostolou T, Koutras G. Effects of a Long-Term Supervised Schroth Exercise Program on the Severity of Scoliosis and Quality of Life in Individuals with Adolescent Idiopathic Scoliosis: A Randomized Clinical Trial Study. Medicina (Kaunas). 2024 Oct 7;60(10):1637. doi: 10.3390/medicina60101637. PMID 39459424
  • Dong H, You M, Li Y, Wang B, Huang H. Physiotherapeutic Scoliosis-Specific Exercise for the Treatment of Adolescent Idiopathic Scoliosis: A Systematic Review and Network Meta-analysis. Am J Phys Med Rehabil. 2024 Jan 1;104(1):14-25. doi: 10.1097/PHM.0000000000002524. Epub 2024 May 10. PMID 38726971
  • Negrini S, Hresko TM, O'Brien JP, Price N; SOSORT Boards; SRS Non-Operative Committee. Recommendations for research studies on treatment of idiopathic scoliosis: Consensus 2014 between SOSORT and SRS non-operative management committee. Scoliosis. 2015 Mar 7;10:8. doi: 10.1186/s13013-014-0025-4. eCollection 2015. PMID 25780381

Идентификаторы

NCT: NCT07459400 · 22.01.2026-139

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗