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Foot Reflexology in Ocular Hypertensive and Glaucoma Patients

Primary Purpose

Ocular Hypertension, Glaucoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Massage
Experimental insert
Sham insert
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ocular Hypertension

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Temple University Hospital Ophthalmology Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Glaucoma Group

Ocular Hypertension Group A

Ocular Hypertension Group B

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Intraocular Pressure Changes in Glaucoma Patients
Glaucoma Patients
Intraocular Pressure Changes in Ocular Hypertensive Patients
Ocular Hypertensive Patients
Intraocular Pressure Changes in Ocular Hypertensive Patients
Ocular Hypertensive Patients
Intraocular Pressure Changes in Ocular Hypertensive Patients
Ocular Hypertensive Patients

Secondary Outcome Measures

Full Information

First Posted
December 23, 2020
Last Updated
February 2, 2021
Sponsor
Temple University
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1. Study Identification

Unique Protocol Identification Number
NCT04695314
Brief Title
Foot Reflexology in Ocular Hypertensive and Glaucoma Patients
Official Title
Effect of Foot Reflexology on Intraocular Pressure in Ocular Hypertensive and Glaucoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 7, 2017 (Actual)
Primary Completion Date
November 18, 2020 (Actual)
Study Completion Date
November 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Glaucoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glaucoma Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Ocular Hypertension Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Ocular Hypertension Group B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Massage
Other Intervention Name(s)
JAPAN TSUBO HH-700
Intervention Description
Foot reflexology board (JAPAN TSUBO HH-700) with massage focused at the base of the second and third toes
Intervention Type
Procedure
Intervention Name(s)
Experimental insert
Intervention Description
Raised shoe insert, insert used for massage
Intervention Type
Procedure
Intervention Name(s)
Sham insert
Intervention Description
Flat shoe insert, insert used for massage
Primary Outcome Measure Information:
Title
Intraocular Pressure Changes in Glaucoma Patients
Description
Glaucoma Patients
Time Frame
Collect pressure readings for baseline, after 5 minutes of massage, and every 30 minutes for 2 hours
Title
Intraocular Pressure Changes in Ocular Hypertensive Patients
Description
Ocular Hypertensive Patients
Time Frame
Collect pressure readings for baseline, after 5 minutes of massage, and every 30 minutes for 2 hours
Title
Intraocular Pressure Changes in Ocular Hypertensive Patients
Description
Ocular Hypertensive Patients
Time Frame
Baseline and after experimental foot insert intervention, over an average of 8 hours
Title
Intraocular Pressure Changes in Ocular Hypertensive Patients
Description
Ocular Hypertensive Patients
Time Frame
Baseline and after sham foot insert intervention, over an average of 8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Temple University Hospital Ophthalmology Clinic
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Foot Reflexology in Ocular Hypertensive and Glaucoma Patients

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