Foot Reflexology in Ocular Hypertensive and Glaucoma Patients

Temple University27 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Ocular Hypertension Glaucoma

Interventions

MassageDEVICE

Foot reflexology board (JAPAN TSUBO HH-700) with massage focused at the base of the second and third toes

Experimental insertPROCEDURE

Raised shoe insert, insert used for massage

Sham insertPROCEDURE

Flat shoe insert, insert used for massage

Eligibility

Sex: ALLMin age: 30 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. The exclusion criteria 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: * Diabetes * Parkinson's Disease * Neuropathy * Gait Abnormalities

Locations (1)

Temple University Hospital Ophthalmology Clinic

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Intraocular Pressure Changes in Glaucoma Patients

Glaucoma Patients

Time frame: Collect pressure readings for baseline, after 5 minutes of massage, and every 30 minutes for 2 hours

Intraocular Pressure Changes in Ocular Hypertensive Patients

Ocular Hypertensive Patients

Time frame: Collect pressure readings for baseline, after 5 minutes of massage, and every 30 minutes for 2 hours

Intraocular Pressure Changes in Ocular Hypertensive Patients

Ocular Hypertensive Patients

Time frame: Baseline and after experimental foot insert intervention, over an average of 8 hours

Intraocular Pressure Changes in Ocular Hypertensive Patients

Ocular Hypertensive Patients

Time frame: Baseline and after sham foot insert intervention, over an average of 8 hours

Data from ClinicalTrials.gov

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