Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension
Sponsor
Temple University (Other)
Overall Status
Completed
CT.gov ID
NCT02993445
Collaborator
(none)
11
2
17
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the effect of complementary and alternative therapies, specifically alternate nostril breathing and foot reflexology, on intraocular pressure in patients with ocular hypertension.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
11 patients were recruited from Temple Ophthalmology between 2014 and 2016. Patients had ocular hypertension and were between the ages of 48-74. Patients were excluded if they currently performed ANB or FR, were unable to perform the task, had previous eye surgery or laser, were receiving other CAM for ocular hypertension, or were unable to complete a washout period. After a 30-day drug washout, patients completed either ANB or FR. After instruction, the assigned task was performed for 5 minutes. FR was done on a commercially available foot reflexology board (JAPAN TSUBO HH-700) focused at the base of the second and third toes of both feet. Two weeks later, patients completed the alternate task. IOP was measured before the task, immediately after the task and then every 30 minutes for two hours. Sign rank tests were used to evaluate IOP changes within and between each group.
Study Design
Study Type:
Interventional
Actual Enrollment
:
11 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study on the Effect of Alternate Nostril Breathing and Foot Reflexology on Intraocular Pressure in Ocular Hypertension
Study Start Date
:
Sep 1, 2014
Actual Primary Completion Date
:
Feb 1, 2016
Actual Study Completion Date
:
Feb 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Alternate Nostril Breathing The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes. |
Other: Alternate Nostril Breathing
|
| Experimental: Foot Reflexology The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. This board has two foot shaped pieces of wood mounted on a flat board with springs. On top of these wooden feet are small wooden nodes, which are organized at precise locations to activate the reflexology of the foot by stimulation certain pressure points. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes. |
Device: Foot Reflexology
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Intraocular Pressure (mmHg) [2 hours]
Measurement of intraocular pressure after each treatment for 30min intervals for total of 2hours. Time points used in the calculation include baseline, 30 mins, 60 mins, 90 mins, and 120 mins.
- Change From Baseline in Intraocular Pressure (mmHg) [2 hours]
Measurement of intraocular pressure after each treatment for 30min intervals for total of 2hours. Time points used in the calculation include baseline, 30 mins, 60 mins, 90 mins, and 120 mins. This is after the 2 week washout period. Participants have switched interventions
Eligibility Criteria
Criteria
Ages Eligible for Study:
30 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- patients with ocular hypertension
Exclusion Criteria:
-
currently performed alternate nostril breathing or foot reflexology
-
were unable to perform the task
-
had previous eye surgery or laser,
-
were receiving other CAM for ocular hypertension
-
were unable to complete a washout period if they using glaucoma eye drops
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Temple University
Investigators
- Principal Investigator: Jeffrey Henderer, M.D., Temple University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Temple University
ClinicalTrials.gov Identifier:
NCT02993445
Other Study ID Numbers:
- 22105
First Posted:
Dec 15, 2016
Last Update Posted:
Nov 27, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | After a 30-day drug washout, patients were randomly assigned to complete either ANB or FR for 5 min. After instruction, patients completed either ANB or FR, and completed the alternate task 2 weeks later. |
| Arm/Group Title | Alternate Nostril Breathing First, Then Foot Reflexology | Foot Reflexology First, Then Alternate Nostril Breathing |
|---|---|---|
| Arm/Group Description | The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes. Patients will complete 2 week wash out and then return for foot reflexology. The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes. | The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes. Patients will complete 2 week wash out and then return for alternate nostril breathing. The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes. |
| Period Title: First Intervention (5 Minutes) | ||
| STARTED | 6 | 5 |
| COMPLETED | 6 | 5 |
| NOT COMPLETED | 0 | 0 |
| Period Title: First Intervention (5 Minutes) | ||
| STARTED | 6 | 5 |
| COMPLETED | 6 | 5 |
| NOT COMPLETED | 0 | 0 |
| Period Title: First Intervention (5 Minutes) | ||
| STARTED | 6 | 5 |
| COMPLETED | 6 | 5 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Alternate Nostril Breathing First, Then Foot Reflexology | Foot Reflexology First, Then Alternate Nostril Breathing | Total |
|---|---|---|---|
| Arm/Group Description | The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes. Patients will complete 2 week wash out and then return for foot reflexology. The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes. | The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes. Patients will complete 2 week wash out and then return for alternate nostril breathing. The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes. | Total of all reporting groups |
| Overall Participants | 6 | 5 | 11 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
60.0
(9.69)
|
65.4
(7.44)
|
62.64
(8.81)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
3
50%
|
3
60%
|
6
54.5%
|
| Male |
3
50%
|
2
40%
|
5
45.5%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
3
50%
|
3
60%
|
6
54.5%
|
| White |
3
50%
|
2
40%
|
5
45.5%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Corneal Thickness (mm) [Mean (Standard Deviation) ] | |||
| Right Eye |
567.8
(36.78)
|
572.7
(37.0)
|
569.6
(34.21)
|
| Left Eye |
568.2
(39.7)
|
575.3
(53.1)
|
570.88
(41.49)
|
Outcome Measures
| Title | Change From Baseline in Intraocular Pressure (mmHg) |
|---|---|
| Description | Measurement of intraocular pressure after each treatment for 30min intervals for total of 2hours. Time points used in the calculation include baseline, 30 mins, 60 mins, 90 mins, and 120 mins. |
| Time Frame | 2 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Alternate Nostril Breathing Alternate Nostril Breathing First, Then Foot Reflexology | Foot Reflexology First, Then Alternate Nostril Breathing |
|---|---|---|
| Arm/Group Description | The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes. Patients will complete 2 week wash out and then return for foot reflexology. The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes. | The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes. Patients will complete 2 week wash out and then return for alternate nostril breathing. The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes. |
| Measure Participants | 6 | 5 |
| Measure eyes | 12 | 10 |
| Baseline |
25.3
(1.61)
|
26.8
(4.39)
|
| 30 minutes IOP |
23.9
(2.19)
|
22.5
(4.12)
|
| 60 minutes IOP |
23.5
(2.35)
|
22.7
(4.03)
|
| 90 minutes IOP |
21
(2.66)
|
22.5
(3.64)
|
| 120 minutes IOP |
22.6
(2.9)
|
25.3
(1.28)
|
| Title | Change From Baseline in Intraocular Pressure (mmHg) |
|---|---|
| Description | Measurement of intraocular pressure after each treatment for 30min intervals for total of 2hours. Time points used in the calculation include baseline, 30 mins, 60 mins, 90 mins, and 120 mins. This is after the 2 week washout period. Participants have switched interventions |
| Time Frame | 2 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Alternate Nostril Breathing Alternate Nostril Breathing First, Then Foot Reflexology | Foot Reflexology First, Then Alternate Nostril Breathing |
|---|---|---|
| Arm/Group Description | The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes. Patients will complete 2 week wash out and then return for foot reflexology. The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes. | The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes. Patients will complete 2 week wash out and then return for alternate nostril breathing. The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes. |
| Measure Participants | 6 | 5 |
| Measure eyes | 12 | 10 |
| Baseline |
24.3
(2.22)
|
26.5
(4.43)
|
| 30 minutes IOP |
21.3
(2.00)
|
23.9
(3.99)
|
| 60 minutes IOP |
20.6
(2.00)
|
23.45
(4.02)
|
| 90 minutes IOP |
20.4
(2.08)
|
22.7
(4.33)
|
| 120 minutes IOP |
20.6
(2.23)
|
22.7
(3.65)
|
Adverse Events
| Time Frame | 1 hour after each task patients were assessed for adverse events | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Alternate Nostril Breathing | Foot Reflexology | ||
| Arm/Group Description | The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes. Alternate Nostril Breathing | The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. This board has two foot shaped pieces of wood mounted on a flat board with springs. On top of these wooden feet are small wooden nodes, which are organized at precise locations to activate the reflexology of the foot by stimulation certain pressure points. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes. Foot Reflexology | ||
All Cause Mortality |
||||
| Alternate Nostril Breathing | Foot Reflexology | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/11 (0%) | 0/11 (0%) | ||
Serious Adverse Events |
||||
| Alternate Nostril Breathing | Foot Reflexology | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/11 (0%) | 0/11 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Alternate Nostril Breathing | Foot Reflexology | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/11 (0%) | 0/11 (0%) | ||
Limitations/Caveats
Small sample size; No control group
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Jeffrey Henderer |
|---|---|
| Organization | Temple University Hospital |
| Phone | 267-418-9126 |
| Jeffrey.Henderer@tuhs.temple.edu |
Responsible Party:
Temple University
ClinicalTrials.gov Identifier:
NCT02993445
Other Study ID Numbers:
- 22105
First Posted:
Dec 15, 2016
Last Update Posted:
Nov 27, 2020
Last Verified:
Nov 1, 2020