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OpenTrials
Completed

NCT Number: NCT04695314

Foot Reflexology in Ocular Hypertensive and Glaucoma Patients

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.

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Key information

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Temple University Hospital Ophthalmology Clinic

Philadelphia, Pennsylvania, 19140, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Massage

Device

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 insert

Procedure

Raised shoe insert, insert used for massage

Sham insert

Procedure

Flat shoe insert, insert used for massage

Primary outcomes

  1. Intraocular Pressure Changes in Glaucoma Patients

    Time frame: Collect pressure readings for baseline, after 5 minutes of massage, and every 30 minutes for 2 hours

    Glaucoma Patients

  2. Intraocular Pressure Changes in Ocular Hypertensive Patients

    Time frame: Collect pressure readings for baseline, after 5 minutes of massage, and every 30 minutes for 2 hours

    Ocular Hypertensive Patients

  3. Intraocular Pressure Changes in Ocular Hypertensive Patients

    Time frame: Baseline and after experimental foot insert intervention, over an average of 8 hours

    Ocular Hypertensive Patients

  4. Intraocular Pressure Changes in Ocular Hypertensive Patients

    Time frame: Baseline and after sham foot insert intervention, over an average of 8 hours

    Ocular Hypertensive Patients

Sponsors and collaborators

Lead sponsor

Temple University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 5, 2021
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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