Effect of Foot Reflexology on Intraocular Pressure in Ocular Hypertensive and Glaucoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Intraocular Pressure Changes in Glaucoma Patients
研究概览
简要总结
To determine the effect of foot reflexology in primary open angle glaucoma (POAG) patients and the effect of a shoe insert to perform continuous foot reflexology in ocular hypertensive (OHTN) patients.
详细描述
This is a prospective pilot study in glaucoma patients and a prospective therapeutic trial in ocular hypertensive patients. Patients were recruited from the Temple Ophthalmology outpatient clinic. Primary open-angle glaucoma patients were recruited from those about to have SLT for additional intraocular pressure (IOP) lowering. OHTN patients were recruited from the clinic. The glaucoma patients performed a 5-minute foot massage on a foot massage board and the IOP was checked pre-massage, post-massage and 30, 60, 90 and 120 min post massage. OHTN patients underwent a one-month drop washout and then performed a 5-minute massage using a 3D-printed shoe insert with the identical pressure checks. They then were randomly assigned to wear the shoe insert or a sham insert for one day. IOP was checked before inserting the insert and at the end of the day. The number of steps was recorded each day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria for this study in each study group are as follows.
- •Patients with ocular hypertension (age 30-90) who may or may not have been included in the original pilot study.
- •Patients with POAG (age 30-90) who are being asked to increase therapy to further lower their IOP.
排除标准
- •for BOTH study groups will be:
- •Current participation in FR or other complementary and alternative medicine techniques who will not participate in a washout period.
- •Ocular hypotensive drop treatments for ocular-hypertension who will not participate in a washout period.
- •Previous eye surgery or laser treatment.
- •Physical inability to perform the tasks.
- •Additional exclusion criteria for the Foot Insert ONLY will be:
- •Parkinson's Disease
- •Neuropathy
- •Gait Abnormalities
研究组 & 干预措施
Glaucoma Group
Patients with glaucoma come in and get an intraocular pressure check at baseline. They get a 5 minute foot massage and then have their intraocular pressure checked every 30 minutes over 2 hour span.
干预措施: Massage (Device)
Ocular Hypertension Group A
Patients with OHTN come in and get an IOP check at baseline. They get a 5 minute foot massage and then have their IOP checked every 30 minutes over 2 hour span.
2 week washout period and then patients return. Patients come in the morning to have their IOP checked. Received raised experimental shoe insert. Patients come back in the afternoon to have their IOP checked again.
2 week washout period and then patients return. Patients come in the morning to have their IOP checked. Received sham flat shoe insert. Patients come back in the afternoon to have their IOP checked again.
干预措施: Sham insert (Procedure)
Ocular Hypertension Group A
Patients with OHTN come in and get an IOP check at baseline. They get a 5 minute foot massage and then have their IOP checked every 30 minutes over 2 hour span.
2 week washout period and then patients return. Patients come in the morning to have their IOP checked. Received raised experimental shoe insert. Patients come back in the afternoon to have their IOP checked again.
2 week washout period and then patients return. Patients come in the morning to have their IOP checked. Received sham flat shoe insert. Patients come back in the afternoon to have their IOP checked again.
干预措施: Experimental insert (Procedure)
Ocular Hypertension Group B
Patients with OHTN come in and get an IOP check at baseline. They get a 5 minute foot massage and then have their IOP checked every 30 minutes over 2 hour span.
2 week washout period and then patients return. Patients come in the morning to have their IOP checked. Received sham flat shoe insert. Patients come back in the afternoon to have their IOP checked again.
2 week washout period and then patients return. Patients come in the morning to have their IOP checked. Received raised experimental shoe insert. Patients come back in the afternoon to have their IOP checked again.
干预措施: Experimental insert (Procedure)
Ocular Hypertension Group B
Patients with OHTN come in and get an IOP check at baseline. They get a 5 minute foot massage and then have their IOP checked every 30 minutes over 2 hour span.
2 week washout period and then patients return. Patients come in the morning to have their IOP checked. Received sham flat shoe insert. Patients come back in the afternoon to have their IOP checked again.
2 week washout period and then patients return. Patients come in the morning to have their IOP checked. Received raised experimental shoe insert. Patients come back in the afternoon to have their IOP checked again.
干预措施: Sham insert (Procedure)
结局指标
主要结局
Intraocular Pressure Changes in Glaucoma Patients
时间窗: Collect pressure readings for baseline, after 5 minutes of massage, and every 30 minutes for 2 hours
Glaucoma Patients
Intraocular Pressure Changes in Ocular Hypertensive Patients
时间窗: Baseline and after sham foot insert intervention, over an average of 8 hours
Ocular Hypertensive Patients
Intraocular Pressure Changes in Ocular Hypertensive Patients
时间窗: Collect pressure readings for baseline, after 5 minutes of massage, and every 30 minutes for 2 hours
Ocular Hypertensive Patients
Intraocular Pressure Changes in Ocular Hypertensive Patients
时间窗: Baseline and after experimental foot insert intervention, over an average of 8 hours
Ocular Hypertensive Patients
次要结局
未报告次要终点