Foot Reflexology in Ocular Hypertensive and Glaucoma Patients

Temple University

Status: Completed

Conditions: Glaucoma; Ocular Hypertension

Treatments: Procedure: Experimental insert; Procedure: Sham insert; Device: Massage

Study type: Interventional

Funder types: Other

Identifiers

NCT04695314

24685

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 30 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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27 participants in 3 patient groups

Glaucoma Group

Experimental group

Description:

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.

Treatment:

Device: Massage

Ocular Hypertension Group A

Experimental group

Description:

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.

Treatment:

Procedure: Experimental insert

Procedure: Sham insert

Ocular Hypertension Group B

Active Comparator group

Description:

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.

Treatment:

Procedure: Experimental insert

Procedure: Sham insert