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- Ensayo clínico NCT07571772
The Effect of Hot Compress in Patients With Knee Osteoarthritis
The Effect of Topical Hot Compress Applications With Black Seed (Nigella Sativa) and Ginger (Zingiber Officinale) Essential Oil on Pain and Patient Satisfaction in Patients With Knee Osteoarthritis: A Randomized Controlled Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Knee oteoarthritis (OA) is one of the most common joint diseases worldwide. The prevalence of OA in people aged 20 and over is 203 per 100,000 per year, with 86.7 million people diagnosed with knee OA. In Turkey, the frequency of OA has reached 15%, and it is twice as common in females as in males.
No treatment currently reverses structural deformities caused by OA. Non-pharmacological treatments such as thermotherapy (heat/cold), Tai Chi, yoga, and acupuncture are recommended. Topical applications of herbal extracts and essential oils have also been studied.
Nigella sativa (black cumin) contains thymoquinone, which reduces joint inflammation and rheumatic pain. Zingiber officinale (ginger) has anti-inflammatory and antioxidant effects. Heat application increases blood flow and reduces stiffness and pain.
This randomized controlled experimental study aims to evaluate the effect of hot compress applied with Nigella sativa and Zingiber officinale essential oils on pain, morning stiffness, physical function, and patient satisfaction in knee OA patients.
The study will be conducted at Van Eğitim ve Araştırma Hastanesi, Physical Therapy Unit. Sample size was calculated using G*Power 3.1.7 (α = 0.05, effect size 0.10, power 95%), resulting in 120 participants (30 per group).
Inclusion criteria: aged ≥18 years, physician-diagnosed knee OA, Kellgren-Lawrence stage 3, VAS pain ≥4, no known allergy to the essential oils, no open wound on knee/foot, no knee surgery, not receiving other alternative treatments during the study, and not pregnant.
Exclusion criteria: unwillingness to participate, development of a wound, operation, bruising, or edema in the knee area during the study.
Participants will be randomly assigned to four groups using www.randomization.org:
- Ginger oil + hot compress group
- Black cumin oil + hot compress group
- Sham group (hot compress only)
- Control group (routine treatment only, no additional intervention) A patch test will be performed on the inner forearm with 3 drops of essential oil for participants in groups 1 and 2. If no allergic reaction (dyspnea, itching, redness, rash) occurs within 20 minutes, the participant will be included.
A hot compress will be applied using a thermophore at 40-50°C, wrapped in a thin towel, placed on both knees for 30 minutes, and covered with another towel. This will be performed once daily for 7 days.
Data collection tools:
- Patient Information Form (sociodemographic and clinical characteristics)
- WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) for pain, stiffness, and physical function
- Visual Analog Scale (VAS) for pain (0-10)
- Visual Analog Scale (VAS) for satisfaction (0-10) Assessments will be conducted at baseline (day 1) and at the end of day 7. Statistical analysis will be performed using IBM SPSS 27.0. Descriptive statistics, ANOVA, Kruskal-Wallis, paired t-test, Wilcoxon, and Friedman tests will be used. Post-hoc tests (Tukey for ANOVA, Dunn for Kruskal-Wallis) will be applied. Significance level will be p < 0.05.
Ethical approval was obtained from Osmaniye Korkut Ata University Scientific Ethics Committee (decision no: 4/12, date: 07.04.2026). Institutional permission from Van Eğitim ve Araştırma Hastanesi will be obtained. Written informed consent will be obtained from all participants.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Yakutiye
-
Erzurum, Yakutiye, Turquía (Türkiye)
- Ercan Bakır
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 18 years or older
- Physician-diagnosed knee osteoarthritis according to American College of Rheumatology (ACR) criteria
- Kellgren-Lawrence grade 3 (moderate) osteoarthritis
- Pain score of 4 or higher on Visual Analog Scale (VAS 0-10)
- No known allergy to Nigella sativa (black cumin) or Zingiber officinale (ginger) essential oils
- No open wounds on the knee or foot
- No previous knee surgery
- Not receiving any other alternative treatment (e.g., acupuncture, herbal therapy) during the study period
- Females must not be pregnant
Exclusion Criteria:
- Age under 18 years
- Kellgren-Lawrence grade 1, 2, or 4
- VAS pain score below 4
- Known allergy to the essential oils used
- Open wound on knee or foot
- Previous knee surgery
- Receiving other alternative treatment during the study period
- Pregnancy or breastfeeding
- Unwillingness to participate or inability to provide informed consent
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 |
|---|---|
|
Experimental: Hot Compress Application Group with Black Cumin Oil
Experimental group.
Topical application of 15 drops of Nigella sativa (black cumin) essential oil to each knee with gentle massage, followed by hot compress (thermophore at 40-50°C wrapped in a towel) for 30 minutes.
Applied once daily for 7 days.
Patch test performed before first application to rule out allergy.
Assessments at baseline and day 7: WOMAC, VAS-pain, VAS-satisfaction.
|
Black Cumin Oil was applied to both knees. This practice continued for 7 days. The final test was administered at the end of the 7th day. Ginger Oil was applied to both strings. This practice continued for 7 days. The final test was administered at the end of the 7th day. No intervention was made to the Control Group. He was provided with routine treatment.
Otros nombres:
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|
Experimental: Hot Compress with Ginger Oil Application Group
Experimental group.
Topical application of 15 drops of Zingiber officinale (ginger) essential oil to each knee with gentle massage, followed by hot compress (thermophore at 40-50°C wrapped in a towel) for 30 minutes.
Applied once daily for 7 days.
Patch test performed before first application to rule out allergy.
Assessments at baseline and day 7: WOMAC, VAS-pain, VAS-satisfaction.
|
Black Cumin Oil was applied to both knees. This practice continued for 7 days. The final test was administered at the end of the 7th day. Ginger Oil was applied to both strings. This practice continued for 7 days. The final test was administered at the end of the 7th day. No intervention was made to the Control Group. He was provided with routine treatment.
Otros nombres:
|
|
Sin intervención: Control Group
Control group.
Participants receive routine medical treatment only.
No hot compress and no essential oil application will be performed.
Data collection (patient information form, Kellgren-Lawrence staging, WOMAC, VAS-pain, VAS-satisfaction) will be done at baseline and on day 7.
|
|
|
Comparador falso: Sham Group
Participants in this group receive only hot compress application (thermophore at 40-50°C for 30 minutes once daily for 7 days).
No essential oil is applied.
|
Black Cumin Oil was applied to both knees. This practice continued for 7 days. The final test was administered at the end of the 7th day. Ginger Oil was applied to both strings. This practice continued for 7 days. The final test was administered at the end of the 7th day. No intervention was made to the Control Group. He was provided with routine treatment.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Visual Analog Scale (VAS) - Pain
Periodo de tiempo: Baseline and day 7
|
10 cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain).
Participants mark their current pain intensity.
|
Baseline and day 7
|
|
WOMAC Osteoarthritis Index
Periodo de tiempo: Baseline and day 7
|
Validated 24-item questionnaire assessing pain, stiffness, and physical function in knee osteoarthritis.
Each item scored 1-5 (none to extreme).
Higher scores indicate worse symptoms.
|
Baseline and day 7
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Visual Analog Scale (VAS) - Satisfaction
Periodo de tiempo: Baseline and day 7
|
10 cm horizontal line ranging from 0 (not satisfied at all) to 10 (completely satisfied).
Participants rate their satisfaction with the treatment.
|
Baseline and day 7
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Ercan Bakır, PhD, erzurum tecnical university
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
- Manifestaciones neurológicas
- Enfermedades musculoesqueléticas
- Artritis
- Enfermedades Articulares
- Enfermedades reumáticas
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Signos y síntomas
- Dolor
- Osteoartritis
- Artrosis, Rodilla
- Satisfacción personal
- Técnicas de investigación
- Diseño de investigación epidemiológica
- Métodos epidemiológicos
- Diseño de la investigación
- Métodos
- Grupos de control
Otros números de identificación del estudio
- ercanzencefil
Plan de datos de participantes individuales (IPD)
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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.
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