Foot Reflexology in Ocular Hypertensive and Glaucoma Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma
• Intervention / Treatment: Device: Massage; Procedure: Experimental insert; Procedure: Sham insert

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital Ophthalmology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Massage; Foot reflexology board (JAPAN TSUBO HH-700) with massage focused at the base of the second and third toes; Other Names: JAPAN TSUBO HH-700
Experimental: 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.	Procedure: Experimental insert; Raised shoe insert, insert used for massage; Procedure: Sham insert; Flat shoe insert, insert used for massage
Active Comparator: 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.	Procedure: Experimental insert; Raised shoe insert, insert used for massage; Procedure: Sham insert; Flat shoe insert, insert used for massage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure Changes in Glaucoma Patients	Glaucoma Patients	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	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	Baseline and after experimental foot insert intervention, over an average of 8 hours
Intraocular Pressure Changes in Ocular Hypertensive Patients	Ocular Hypertensive Patients	Baseline and after sham foot insert intervention, over an average of 8 hours

Collaborators and Investigators

• Sponsor: Temple University

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2017
• Primary Completion (Actual): November 18, 2020
• Study Completion (Actual): November 18, 2020

Study Registration Dates

• First Submitted: December 23, 2020
• First Submitted That Met QC Criteria: December 31, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Ocular Hypertension
• Other Study ID Numbers: 24685

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes