Posture Correction for the Treatment of Cubital Tunnel Syndrome (CuTS)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in pain score for pain using a Visual Analogue Scale (VAS)
研究概览
简要总结
The primary objective of this study is to determine whether the UpRight Go posture trainer reduces the symptoms of cubital tunnel syndrome in patients who have not had corrective surgery, as determined by improvements in VAS scores for pain, numbness, and weakness.
详细描述
This is a randomized controlled, non-blinded trial. All patients who are eligible to participate and who consent to participate will be randomized to either receive standard of care treatment alone, or standard of care treatment with the additional intervention of posture training. The nature of the intervention prevents blinding. All patients will be followed for 6 weeks and evaluated for symptom improvement or resolution.
All patients aged 18 and older who present to clinic with cubital tunnel syndrome of any severity and who have not previously undergone surgical intervention for this condition will be eligible to participate in this study. All participants must be amenable to conservative management of CuTS, wearing a posture training device daily, completing the accompanying questionnaires throughout the study, and returning for follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Adult patients, between 18 and 99 years old
- •Exhibiting signs and symptoms consistent with cubital tunnel syndrome including but not limited to pain, numbness, or paresthesia in an ulnar distribution, loss of grip strength, or loss of fine motor control of the fingers.
- •Nerve conduction study, electromyography, MRI or ultrasound results consistent with the diagnosis of cubital tunnel syndrome
- •Ability to wear a posture trainer daily and manage the associated smartphone application and questionnaire
排除标准
- •History of spinal surgery, hand surgery or hand/wrist fracture
- •History of cubital tunnel release surgery or carpal tunnel syndrome
- •Pregnancy or lactation
- •Known allergic reactions to silicon
- •Long-standing history of T2DM, documented neuropathic pain
结局指标
主要结局
Change in pain score for pain using a Visual Analogue Scale (VAS)
时间窗: Baseline and 6 weeks
Pain score assessed using a linear VAS: a straight horizontal line of fixed length (100mm) on which participants will mark the point on the line that they feel represents their perception of their current state. The VAS score is determined by measuring, in millimeters, from the left hand end of the line to the point that the patient marks. The scale ranges from "no pain" to "severe pain". The longer the distance on the line, the more pain.
Change in pain score for weakness using a Visual Analogue Scale (VAS)
时间窗: Baseline and 6 weeks
Pain score for weakness assessed using a linear VAS: a straight horizontal line of fixed length (100mm) on which participants will mark the point on the line that they feel represents their perception of their current state. The VAS score is determined by measuring, in millimeters, from the left hand end of the line to the point that the patient marks. The scale ranges from "no pain" to "severe pain". The longer the distance on the line, the more pain.
Change in pain score for numbness using a Visual Analogue Scale (VAS)
时间窗: Baseline and 6 weeks
Pain score for numbness assessed using a linear VAS: a straight horizontal line of fixed length (100mm) on which participants will mark the point on the line that they feel represents their perception of their current state. The VAS score is determined by measuring, in millimeters, from the left hand end of the line to the point that the patient marks. The scale ranges from "no pain" to "severe pain". The longer the distance on the line, the more pain.
次要结局
- Change in The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire(Baseline and 6 weeks)
- Change in Semmes-Weinstein monofilament testing.(Baseline and 6 weeks)
- Hours per day device was worn(up to 6 weeks)
- Time spent with good posture(up to 6 weeks)
- Change in two-point discrimination testing(Baseline and 6 weeks)
- Change in strength testing via pinch/grip test(Baseline and 6 weeks)
- Change in Medical Research Council (MRC) Scale for Muscle Strength(Baseline and 6 weeks)
- Change in range of motion testing(Baseline and 6 weeks)
- Change in Boston Carpal Tunnel Syndrome (BCTS) questionnaire(Baseline and 6 weeks)