Foot Reflexology in Ocular Hypertensive and Glaucoma Patients

Sponsor

Temple University (Other)

Overall Status

Completed

CT.gov ID

NCT04695314

Collaborator

(none)

Enrollment

Location

Arms

36.4

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Hypertension Glaucoma	Device: Massage Procedure: Experimental insert Procedure: Sham insert	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 7, 2017

Actual Primary Completion Date :

Nov 18, 2020

Actual Study Completion Date :

Nov 18, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Intraocular Pressure Changes in Glaucoma Patients [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 [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 [Baseline and after experimental foot insert intervention, over an average of 8 hours]
Ocular Hypertensive Patients
Intraocular Pressure Changes in Ocular Hypertensive Patients [Baseline and after sham foot insert intervention, over an average of 8 hours]
Ocular Hypertensive Patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Temple University Hospital Ophthalmology Clinic	Philadelphia	Pennsylvania	United States	19140

Sponsors and Collaborators

Temple University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Temple University

ClinicalTrials.gov Identifier:

NCT04695314

Other Study ID Numbers:

24685

First Posted:

Jan 5, 2021

Last Update Posted:

Feb 5, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Glaucoma

Ocular Hypertension

Study Results

No Results Posted as of Feb 5, 2021