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

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

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..

Study Overview

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Gaziosmanpasa
      • Istanbul, Gaziosmanpasa, Turkey (Türkiye), 34255
        • Recruiting
        • Gaziosmanpasa Training and Research Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Serap Seringec Karabulut, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
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.
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 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).
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
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.
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.
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.
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 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).
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adam's Test
Time Frame: 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).
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
Time Frame: 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.
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)
Time Frame: 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
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)
Time Frame: 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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire of Physiotherapeutic Specific Exercises of Scoliosis-QPSSE
Time Frame: 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 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.
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
Time Frame: 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 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Ebru Yilmaz Yalcinkaya, MD,Professor, Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
  • Principal Investigator: Sinem Turkmen Ozoguz, MD, Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
  • Study Chair: Deniz Oke, MD, Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
  • Study Chair: Serap Seringec Karabulut, MD, Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2026

Primary Completion (Estimated)

September 25, 2026

Study Completion (Estimated)

October 23, 2026

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe