Home-based Instrument-assisted Soft Tissue Mobilization for Pain Relief in Patients With Iliotibial Band Syndrome: A Prospective, Pre-post Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Pain intensity during the day
研究概览
简要总结
The aim of the study is to test how well the Sidekick Tool works as a home-based pain relief for iliotibial band syndrome using instrument assisted soft tissue mobilization tool in healthy participants aged 18-65 years old. We hypothesize that the use of the tool over the course of seven days and by following a home-treatment plan will result in less pain that is caused by iliotibial band syndrome for the participants. Pain intensity will be measured using a Numerical Pain Rating Scale from 0-to-10. Other measurements will include pain intensity after exercise and if participants return to their sport.
Participants will be asked to complete an online questionnaire to ensure they are a good fit for the study. Once they have been entered into the study, they will complete a video call with the researchers to go gather their current pain intensity levels. Participants will be emailed the instructions for how to use the tool for seven days and will be mailed the Sidekick Tool to their home.
After seven days of using the tool, the participants will be asked to complete a final video call to gather their pain intensity levels. This number will be compared to their initial pain intensity to see if their pain has lowered while using the tool.
详细描述
The objective of the study is to provide evidence to support the home-based treatment of muscle scraping for iliotibial band syndrome (ITBS). The hypothesis of the researchers is that using the instrument assisted soft tissue mobilization (IASTM) tool provided by Sidekick, will result in reduced pain after following a home-treatment plan for seven days. The study aims to provide evidence for non-invasive treatments to reduce the healthcare costs and burden.
Prior to the commencement of the study, all the subjects selected signed an informed consent document, as defined by the Declaration of Helsinki. The sponsor is Sidekick Inc and the principal investigator is under direct employment of the sponsor.
The study is a single group, pre- post-test comparison, following STROBE guidelines on a group of 30-40 healthy participants. An incentive of $50 USD will be provided to the participants at completion of study, as well, the participants will get to keep the tool but are not told this.
The Sidekick tool used will be the Swerve, which will be mailed to participants once the eligibility questionnaire, informed consent, pre-test questionnaire and initial video call are completed. Participants will be informed to not start new pharmacological interventions, no new stretching, no in-person treatments with a clinician/healthcare professional during the seven day intervention period. Participants will use a tracker to monitor use of the tool and pain responses.
Participants will receive the following detailed instructions for use of the Sidekick tool:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosed (have them enter the month of diagnosis) by a physician or physical therapist
- •pain on lateral side of knee
- •tenderness on palpation at lateral knee
- •unilateral symptoms only
- •past treatments can include rolling, stretching
- •pain duration of 3-12 weeks
排除标准
- •bilateral symptoms
- •no diagnosis
- •other knee pain conditions
- •prior surgeries of the lower limb
- •current pharmacological treatments
- •Any contraindications including:
- •open wounds or unhealed sites Thrombophlebitis uncontrolled hypertension or high blood pressure skin infections Current hematoma myositis ossificans Boney fractures high pain sensation acute inflammatory conditions congestive heart disease circulatory disorders Osteoporosis Cancer Pregnancy Type 1 diabetes Type 2 diabetes varicose veins kidney dysfunction rheumatoid arthritis Lymphedema chronic regional pain syndrome Current use of steroidal medications Current use of anticoagulant medications Current use of NSAID medications (non-steroidal anti-inflammatory drugs)
结局指标
主要结局
Pain intensity during the day
时间窗: Day 0, Day 7
Numerical pain rating scale 0-to-10
次要结局
- Pain intensity after exercise(Day 0, Day 7)
- Return to sport(Day 0, day 7)
- Number of participants with adverse effects after use of intervention(Day 0, Day 7)
研究者
Hannah Antony
Product Education Lead
Sidekick In