THE EFFECT OF THE COMBINATION OF PELOIDOTHERAPY AND EXERCISE ON PAIN INTENSITY, FUNCTIONALITY, AND QUALITY OF LIFE IN PATIENTS WITH CHRONIC LOW BACK PAIN
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable low-back-pain
Started Jan 2022
Shorter than P25 for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedFirst Submitted
Initial submission to the registry
May 15, 2026
CompletedFirst Posted
Study publicly available on registry
May 22, 2026
CompletedMay 22, 2026
May 1, 2026
2 months
May 15, 2026
May 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain İntensity
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.
6 weeks
Secondary Outcomes (2)
Functional Disability Index (ODI)
6 weeks
SF-36 Health Survey (SF-36)
6 weeks
Study Arms (2)
Peloidotherapy Plus Exercise Group (PPEG)
ACTIVE COMPARATORIn addition to pleoidterapy, participnats in the PPEG performed a structured core stabilization exercises 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 Group (PG)
ACTIVE COMPARATORParticipants in the PG received 10 sessions of peloidotherapy. 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.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Arel University
Istanbul, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2026
First Posted
May 22, 2026
Study Start
January 31, 2022
Primary Completion
April 4, 2022
Study Completion
June 30, 2022
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share