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Completed

NCT Number: NCT07601789

THE EFFECT OF THE COMBINATION OF PELOIDOTHERAPY AND EXERCISE ON PAIN INTENSITY, FUNCTIONALITY, AND QUALITY OF LIFE IN PATIENTS WITH CHRONIC LOW BACK PAIN

The aim of our study is to investigate the effect of peloidotherapy and exercise combination applied on patients with chronic low back pain on pain level, functionality and quality of life. Forty patients between the ages of 18-65 who were diagnosed with chronic low back pain were included. The patients were randomly divided into two groups as the peloidotherapy and exercise group (n=20) and the peloidotherapy group (n=20). Peloidotherapy was applied to the peloidotherapy and peloidotherapy and exercise groups in 10 sessions, 30 minutes, 45°C package. In addition, after peloidotherapy, core stabilization exercises were applied to the peloidotherapy and exercise group for 10 sessions, 5 days a week, for 30 minutes.

The patients were evaluated before the first session, after the 10th session and one month after the treatment. Pain level was evaluated with the Visual Analogue Scale (VAS), functionality was evaluated with the Oswestry Low Back Pain Disability Questionnaire (ODI), and quality of life was evaluated with the Short Form-36 (SF36). After the applications, statistically significant improvement was achieved in both groups (p<0.05). The outcomes of the peloidotherapy and exercise group were found to be superior to the peloidotherapy group after the 10th session. At the end of the first month, it was observed that the combination of peloidotherapy and exercise therapy in chronic low back pain had a significant improvement in pain, functionality and quality of life

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Key information

Conditions

Low Back Pain Back Pain Behavior Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Low Back Pain, Chronic Lung Diseases Lung Diseases, Obstructive Motor Activity Neurologic Manifestations Organizing Pneumonia Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Arel University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants were included if they had low back pain persisting for longer than 3 months and were diagnosed with chronic low back pain by a specialist physician, were between 18 and 65 years of age, had not received peloidotherapy within the previous 6 months, and provided written informed consent.

Exclusion criteria

Participants were excluded if they had an active tumor, a disease associated with bleeding, a vertebral fracture, or had undergone surgical intervention within the previous 6 months. Individuals with poor cooperation, inability to comply with study procedures, or failure to provide written informed consent were also excluded from the study.

Treatment and study plan

Peloidotherapy Plus Exercise Group (PPEG)

Other

Participants in both group received 10 sessions of peloidotherapy administered as a 45°C mud pack for 30 minutes per session. The peloid material used during treatment was Pelomin® obtained from Tuzla Thermal Springs, with a total mineralization level of 4145 mg/L. In addition to peloidotherapy, participants in the PPEG performed a structured core stabilization exercise program for 30 minutes per session, 5 days per week, for a total of 10 sessions. The exercise program consisted of progressive exercises targeting trunk stability and lumbopelvic control.

Peloidotherapy (PG)

Other

Participants in both group received 10 sessions of peloidotherapy administered as a 45°C mud pack for 30 minutes per session. The peloid material used during treatment was Pelomin® obtained from Tuzla Thermal Springs, with a total mineralization level of 4145 mg/L

Primary outcomes

  1. Pain İntensity

    Time frame: 6 weeks

    Pain intensity was evaluated using the Visual Analog Scale (VAS), a widely used self-reported tool in clinical practice and research. The VAS consists of a 10-cm (100-mm) horizontal or vertical line anchored by descriptors such as "no pain" and "worst imaginable pain," on which participants mark their perceived pain level.

Secondary outcomes

  1. Functional Disability Index (ODI)

    Time frame: 6 weeks

    Functional disability was assessed using the Oswestry Disability Index (ODI), a widely used questionnaire designed to evaluate disability related to low back pain and its impact on daily activities

  2. SF-36 Health Survey (SF-36)

    Time frame: 6 weeks

    Health-related quality of life was assessed using the Short Form-36 Health Survey (SF-36), a widely used generic questionnaire designed to evaluate physical and mental health status. The SF-36 consists of 36 items covering eight domains: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health

Sponsors and collaborators

Lead sponsor

Istanbul Arel University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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