Foot Reflexology in Ocular Hypertensive and Glaucoma Patients

NCT ID: NCT04695314

Last Updated: 2021-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-07
• Study Completion Date: 2020-11-18

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.

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.

Conditions

Ocular Hypertension; Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Massage

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Experimental insert

Intervention Type: PROCEDURE

Raised shoe insert, insert used for massage

Sham insert

Intervention Type: PROCEDURE

Flat shoe insert, insert used for massage

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.

Group Type: ACTIVE_COMPARATOR

Experimental insert

Intervention Type: PROCEDURE

Raised shoe insert, insert used for massage

Sham insert

Intervention Type: PROCEDURE

Flat shoe insert, insert used for massage

Interventions

Massage

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

Intervention Type: DEVICE

Experimental insert

Raised shoe insert, insert used for massage

Intervention Type: PROCEDURE

Sham insert

Flat shoe insert, insert used for massage

Intervention Type: PROCEDURE

Other Intervention Names

JAPAN TSUBO HH-700

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Diabetes
• Parkinson's Disease
• Neuropathy
• Gait Abnormalities

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Temple University Hospital Ophthalmology Clinic

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

24685

Identifier Type: -

Identifier Source: org_study_id