A Pilot, Randomized Controlled Trial Evaluating the Effectiveness of Paraffin Wax On Burn Patient Function, Range of Motion and Scar
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Range of motion
研究概览
简要总结
This study is being done to test if paraffin wax can be used to improve the range of motion and function for scars across joints when used in combination with scar rehabilitation therapy sessions. For those randomized to receive it, the paraffin wax will be used alongside the participants' exercise therapy treatments. Currently, treatments that are used in addition to rehabilitation therapy for increasing range of motion across joints in the burn population are limited. By getting more information about how paraffin wax may or may not work, patients in the future that have scars may be able to be helped.
详细描述
If the participants agree to take part in this study, the participants scars will be looked at and the investigators will select one site that will be involved in the research. The scar will be "randomized" to the paraffin wax or no paraffin wax groups. The treatment the participants get will be chosen by chance, like flipping a coin. Neither the participants nor the study doctor will choose what treatment you get. The participants will have a 50% chance of being given either paraffin wax or not.
The study will take place in an outpatient setting. The participants will not be admitted to the hospital overnight. All patients who enter the study will be required to follow-up for regular appointments with their burn department.
Before the participants begin treatment, the participants will come in for a pre-treatment visit where the investigators will collection information about the participants scars such as pictures, range of motion measurements, non-invasive probes, non-invasive imaging (Laser doppler imaging) and questionnaires. These questionnaires will be related to the symptoms, range of motion, function, and appearance of the participants' burn scars. At the pre-treatment visit, there is an also an optional blood draw where less than 2 tablespoons of blood are collected. It is estimated this visit will take less than 1 hour. The investigators will also collect information from the medical record about prior surgical and medical history.
Exercise treatments (which the participants have previously chosen to undergo in talking with the participants doctor) will occur approximately in 1-2-week intervals depending on what the Burn Center scheduling department allows. For completion of this study, the participants will undergo 4 exercise therapy sessions which may take about 8 weeks.
At each visit, the following measurements will be captured before and after each exercise session. Those assigned to the paraffin wax group will have an additional assessment collected before their exercise therapy session and after the paraffin wax has been removed. Measurements at each visit include active and passive range of motion measurements of the affected joint, non-invasive probe measurements to measure water loss and hardness of your scar and the adjacent area of normal skin, digital photography, non-invasive laser doppler imaging (LDI), surface-level skin temperature measurements using either an infrared thermometer or skin temperature strip as well as pain and itch rating scales.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patients with burn scar that crosses an upper or lower extremity joint (shoulder, elbow, wrist, hand, hip, knee, ankle)
- •Patients that have been prescribed a rehabilitation program where paraffin wax could be used as an adjunct to rehab exercise therapy
排除标准
- •Adults unable to provide informed consent
- •Injury etiology other than burn (ex: cutaneous trauma, cold injury, etc.)
- •Pregnant women
- •Prisoners
研究组 & 干预措施
Exercise Therapy Only
干预措施: standard of care exercise therapy (Device)
Exercise Therapy with Paraffin Wax Treatment
干预措施: paraffin wax (Device)
Exercise Therapy with Paraffin Wax Treatment
干预措施: standard of care exercise therapy (Device)
结局指标
主要结局
Range of motion
时间窗: 4th exercise session, an average of 4 weeks post enrollment
Range of motion (degrees) of the affected joint before and after paraffin wax between the paraffin and no paraffin groups
次要结局
- Trans-epidermal water loss(4th exercise session, an average of 4 weeks post enrollment)
- Stiffness(4th exercise session, an average of 4 weeks post enrollment)
- Pain visual analog scale(4th exercise session, an average of 4 weeks post enrollment)
- Itch visual analog scale(4th exercise session, an average of 4 weeks post enrollment)
- Scar surface temperature(4th exercise session, an average of 4 weeks post enrollment)
- Patient and observer scar assessment scale(4th exercise session, an average of 4 weeks post enrollment)
- Perfusion(4th exercise session, an average of 4 weeks post enrollment)
- Lower extremities functional scale(4th exercise session, an average of 4 weeks post enrollment)
- Disabilities of the shoulder and hand(4th exercise session, an average of 4 weeks post enrollment)
研究者
Bonnie Carney
Research Scientist, Assistant Professor, Principal Investigator
Medstar Health Research Institute
