Effect of Paraffin Wax on Joint Contractures
Effects of Paraffin Wax Therapy on Passive Range of Motion Post-burn Injury: a Pilot Randomized Control Trial
Limited studies have objectively evaluated the benefit on skin pliability, and relieving itch and pain of paraffin wax, nor has paraffin wax treatment been compared to mineral oil, which is an ingredient in therapeutic paraffin wax. The objective of this study is to examine the immediate impact after paraffin treatment compared with mineral oil controls on joint passive range of motion.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The development of joint contractures after a burn injury represents one of the most important morbidities leading to reduced function and quality of life. Paraffin wax is commonly applied to contracted joints for its proposed benefits of increasing skin pliability, and/or relieving itch and pain. This pilot study will determine the feasibility of performing a fully powered study to objectively evaluate whether paraffin wax therapy significantly improves PROM in adult burn survivors with joint contractures of greater than 15% normal joint ROM (upper or lower extremity) compared to equivalent mineral oil treated joint contractures. This study will characterize the changes in PROM, AROM, itch, and pain in adult burn survivors immediately after the application of paraffin wax treatment relative to an intra-individual control scar treated with mineral oil. This will be a prospective, evaluator-blinded, intra-individual, randomized, controlled, pre-post pilot study.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jakub Sawicki, MSc
- Número de teléfono: 4229 514-288-8201
- Correo electrónico: jakub.sawicki.chum@ssss.gouv.qc.ca
Copia de seguridad de contactos de estudio
- Nombre: Tomas Gagnon, MSc, PT
- Número de teléfono: 514-974-9702
- Correo electrónico: tomas.gagnon.vmed@ssss.gouv.qc.ca
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adult burn survivors (16 years and older)
- Have joint contractures ≥15% normal PROM at two different joints directly related to their burn injury/scars
- Are proficient in English and/or French
- Provide informed consent
Exclusion Criteria:
- Patients who have a cognitive/psychiatric condition that could impair their understanding of the consent process or adherence to protocol procedures
- Patients with neurological impairments related to their burn injury, such as a drop foot or a drop wrist
- Patients with pre-burn joint pathology that limited their PROM
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Joint contractures 1 wax, 2 oil
Two selectionned joint contractures on a single participant. Interventions : one joint with paraffin wax, second joint with mineral oil |
Application of Paraffin wax on joint contracture for 20 mins before removal Application of Mineral oil on joint contracture for 20 mins before removal |
|
Experimental: Joint contractures 1 oil, 2 wax
Two selectionned joint contractures on a single participant. Interventions : one joint with mineral oil, second joint with paraffin wax |
Application of Paraffin wax on joint contracture for 20 mins before removal Application of Mineral oil on joint contracture for 20 mins before removal |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
PROM changes
Periodo de tiempo: 20 minutes (enrollment to end of visit)
|
Passive range of motion of joint contractures treated with Paraffin wax or Mineral oil, before and after treatment, following regular and revised scar goniometry in extension and flexion |
20 minutes (enrollment to end of visit)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
AROM changes
Periodo de tiempo: 20 minutes (enrollment to end of visit)
|
active range of motion of joint contractures treated with paraffin wax or mineral oil, before and after treatment, following regular and revised scar goniometry in extension and flexion |
20 minutes (enrollment to end of visit)
|
|
Pain changes in joint contractures
Periodo de tiempo: 20 minutes (enrollment to end of visit)
|
Subjective pain of joint contractures treated with paraffin wax or mineral oil (before and after) with Visual analog thermometer |
20 minutes (enrollment to end of visit)
|
|
Itch changes in joint contractures
Periodo de tiempo: 20 minutes (enrollment to end of visit)
|
Subjective itch of joint contractures treated with paraffin wax or mineral oil (before and after) with Visual analog thermometer |
20 minutes (enrollment to end of visit)
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Bernadette Nedelec, PhD, OT(c), Centre hospitalier de l'Université de Montréal (CHUM)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Otros números de identificación del estudio
- 2027-13919
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.
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