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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07601789
Enrollment
40
Registered
2026-05-22
Start date
2022-01-31
Completion date
2022-06-30
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Low Back Pain, Chronic

Keywords

peloidotherapy, exercise

Brief summary

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

Interventions

OTHERPeloidotherapy Plus Exercise Group (PPEG)

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.

OTHERPeloidotherapy (PG)

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

Sponsors

Istanbul Arel University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain İntensity6 weeksPain 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

MeasureTime frameDescription
Functional Disability Index (ODI)6 weeksFunctional 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
SF-36 Health Survey (SF-36)6 weeksHealth-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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026