Foot Reflexology in Ocular Hypertensive and Glaucoma Patients

NCT04695314 | Completed FDA Device

• 1 other identifier: 24685
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Hypertension; Glaucoma

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Glaucoma Group

EXPERIMENTAL

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

Ocular Hypertension Group A

EXPERIMENTAL

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; Procedure: Sham insert

Ocular Hypertension Group B

ACTIVE COMPARATOR

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; Procedure: Sham insert

Interventions

Massage DEVICE

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

Also known as: JAPAN TSUBO HH-700

Glaucoma Group

Experimental insert PROCEDURE

Raised shoe insert, insert used for massage

Ocular Hypertension Group A; Ocular Hypertension Group B

Sham insert PROCEDURE

Flat shoe insert, insert used for massage

Ocular Hypertension Group A; Ocular Hypertension Group B

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University Hospital Ophthalmology Clinic

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma

Interventions

Massage

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 5, 2021
• Study Start: November 7, 2017
• Primary Completion: November 18, 2020
• Study Completion: November 18, 2020
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)