- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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-
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Istanbul, Turkiet (Türkiye)
- Istanbul Arel University
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Peloidotherapy Plus Exercise Group (PPEG)
In 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.
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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.
|
|
Aktiv komparator: Peloidotherapy Group (PG)
Participants 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.
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pain İntensity
Tidsram: 6 weeks
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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.
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6 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Functional Disability Index (ODI)
Tidsram: 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
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6 weeks
|
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SF-36 Health Survey (SF-36)
Tidsram: 6 weeks
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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
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6 weeks
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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Nyckelord
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- Patologiska tillstånd, tecken och symtom
- Beteende
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