Effects of Paraffin Wax Therapy on Passive Range of Motion Post-burn Injury: a Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 主要终点
- PROM changes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Paraffin wax (Other)
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
干预措施: Paraffin wax (Other)
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
干预措施: Mineral oil (Other)
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
干预措施: Mineral oil (Other)
结局指标
主要结局
PROM changes
时间窗: 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
次要结局
- AROM changes(20 minutes (enrollment to end of visit))
- Pain changes in joint contractures(20 minutes (enrollment to end of visit))
- Itch changes in joint contractures(20 minutes (enrollment to end of visit))