NCT04695314

Foot Reflexology in Ocular Hypertensive and Glaucoma Patients

Effect of Foot Reflexology on Intraocular Pressure in Ocular Hypertensive and Glaucoma Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Temple University · Academic / Other
• Sex: All
• Age: 30 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Ocular Hypertension
• Glaucoma

Interventions

Type	Name	Description
DEVICE	Massage	Foot reflexology board (JAPAN TSUBO HH-700) with massage focused at the base of the second and third toes
PROCEDURE	Experimental insert	Raised shoe insert, insert used for massage
PROCEDURE	Sham insert	Flat shoe insert, insert used for massage

Timeline

• Start date: 2017-11-07
• Primary completion: 2020-11-18
• Completion: 2020-11-18
• First posted: 2021-01-05
• Last updated: 2021-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study