- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Istanbul, Turquía (Türkiye)
- Istanbul Arel University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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.
|
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.
|
|
Comparador activo: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain İntensity
Periodo de tiempo: 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.
|
6 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Functional Disability Index (ODI)
Periodo de tiempo: 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
|
6 weeks
|
|
SF-36 Health Survey (SF-36)
Periodo de tiempo: 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
|
6 weeks
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Organización de la neumonía
- Dolor
- Manifestaciones neurológicas
- Enfermedades del sistema inmunológico
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Enfermedades bronquiales
- Enfermedades Pulmonares Obstructivas
- Dolor de espalda
- Bronquiolitis Obliterante
- Bronquiolitis
- Bronquitis
- Enfermedad de injerto contra huésped
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Signos y síntomas
- Síndrome de bronquiolitis obliterante
- Lumbalgia
- Actividad del motor
Otros números de identificación del estudio
- ArelUNI
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .