Foot Reflexology in Ocular Hypertensive and Glaucoma Patients

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04695314
• Other study ID #: 24685
• Status: Completed
• Phase: N/A
• Start date: November 7, 2017
• Est. completion date: November 18, 2020

Study information

• Verified date: February 2021
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 18, 2020
• Est. primary completion date: November 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

Intervention

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
• Sham insert
Flat shoe insert, insert used for massage

Locations

Country	Name	City	State
United States	Temple University Hospital Ophthalmology Clinic	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Intraocular Pressure Changes in Ocular Hypertensive Patients	Ocular Hypertensive Patients	Baseline and after experimental foot insert intervention, over an average of 8 hours
Primary	Intraocular Pressure Changes in Ocular Hypertensive Patients	Ocular Hypertensive Patients	Baseline and after sham foot insert intervention, over an average of 8 hours