Ocular Hypertension
Conditions
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.
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.
Interventions
DEVICEFoot Reflexology
Sponsors
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Alternate Nostril Breathing First, Then Foot Reflexology 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. | 6 |
| Foot Reflexology First, Then 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. 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. | 5 |
| Total | 11 |
Baseline characteristics
| Characteristic | Alternate Nostril Breathing First, Then Foot Reflexology | Foot Reflexology First, Then Alternate Nostril Breathing | Total |
|---|---|---|---|
| Age, Continuous | 60.0 years STANDARD_DEVIATION 9.69 | 65.4 years STANDARD_DEVIATION 7.44 | 62.64 years STANDARD_DEVIATION 8.81 |
| Corneal Thickness Left Eye | 568.2 mm STANDARD_DEVIATION 39.7 | 575.3 mm STANDARD_DEVIATION 53.1 | 570.88 mm STANDARD_DEVIATION 41.49 |
| Corneal Thickness Right Eye | 567.8 mm STANDARD_DEVIATION 36.78 | 572.7 mm STANDARD_DEVIATION 37 | 569.6 mm STANDARD_DEVIATION 34.21 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Change From Baseline in Intraocular Pressure (mmHg)
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alternate Nostril Breathing Alternate Nostril Breathing First, Then Foot Reflexology | Change From Baseline in Intraocular Pressure (mmHg) | 30 minutes IOP | 23.9 mm Hg | Standard Deviation 2.19 |
| Alternate Nostril Breathing Alternate Nostril Breathing First, Then Foot Reflexology | Change From Baseline in Intraocular Pressure (mmHg) | 90 minutes IOP | 21 mm Hg | Standard Deviation 2.66 |
| Alternate Nostril Breathing Alternate Nostril Breathing First, Then Foot Reflexology | Change From Baseline in Intraocular Pressure (mmHg) | 60 minutes IOP | 23.5 mm Hg | Standard Deviation 2.35 |
| Alternate Nostril Breathing Alternate Nostril Breathing First, Then Foot Reflexology | Change From Baseline in Intraocular Pressure (mmHg) | 120 minutes IOP | 22.6 mm Hg | Standard Deviation 2.9 |
| Alternate Nostril Breathing Alternate Nostril Breathing First, Then Foot Reflexology | Change From Baseline in Intraocular Pressure (mmHg) | Baseline | 25.3 mm Hg | Standard Deviation 1.61 |
| Foot Reflexology First, Then Alternate Nostril Breathing | Change From Baseline in Intraocular Pressure (mmHg) | 120 minutes IOP | 25.3 mm Hg | Standard Deviation 1.28 |
| Foot Reflexology First, Then Alternate Nostril Breathing | Change From Baseline in Intraocular Pressure (mmHg) | Baseline | 26.8 mm Hg | Standard Deviation 4.39 |
| Foot Reflexology First, Then Alternate Nostril Breathing | Change From Baseline in Intraocular Pressure (mmHg) | 30 minutes IOP | 22.5 mm Hg | Standard Deviation 4.12 |
| Foot Reflexology First, Then Alternate Nostril Breathing | Change From Baseline in Intraocular Pressure (mmHg) | 60 minutes IOP | 22.7 mm Hg | Standard Deviation 4.03 |
| Foot Reflexology First, Then Alternate Nostril Breathing | Change From Baseline in Intraocular Pressure (mmHg) | 90 minutes IOP | 22.5 mm Hg | Standard Deviation 3.64 |
Primary
Change From Baseline in Intraocular Pressure (mmHg)
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alternate Nostril Breathing Alternate Nostril Breathing First, Then Foot Reflexology | Change From Baseline in Intraocular Pressure (mmHg) | 30 minutes IOP | 21.3 mm Hg | Standard Deviation 2 |
| Alternate Nostril Breathing Alternate Nostril Breathing First, Then Foot Reflexology | Change From Baseline in Intraocular Pressure (mmHg) | 90 minutes IOP | 20.4 mm Hg | Standard Deviation 2.08 |
| Alternate Nostril Breathing Alternate Nostril Breathing First, Then Foot Reflexology | Change From Baseline in Intraocular Pressure (mmHg) | 60 minutes IOP | 20.6 mm Hg | Standard Deviation 2 |
| Alternate Nostril Breathing Alternate Nostril Breathing First, Then Foot Reflexology | Change From Baseline in Intraocular Pressure (mmHg) | 120 minutes IOP | 20.6 mm Hg | Standard Deviation 2.23 |
| Alternate Nostril Breathing Alternate Nostril Breathing First, Then Foot Reflexology | Change From Baseline in Intraocular Pressure (mmHg) | Baseline | 24.3 mm Hg | Standard Deviation 2.22 |
| Foot Reflexology First, Then Alternate Nostril Breathing | Change From Baseline in Intraocular Pressure (mmHg) | 120 minutes IOP | 22.7 mm Hg | Standard Deviation 3.65 |
| Foot Reflexology First, Then Alternate Nostril Breathing | Change From Baseline in Intraocular Pressure (mmHg) | Baseline | 26.5 mm Hg | Standard Deviation 4.43 |
| Foot Reflexology First, Then Alternate Nostril Breathing | Change From Baseline in Intraocular Pressure (mmHg) | 30 minutes IOP | 23.9 mm Hg | Standard Deviation 3.99 |
| Foot Reflexology First, Then Alternate Nostril Breathing | Change From Baseline in Intraocular Pressure (mmHg) | 60 minutes IOP | 23.45 mm Hg | Standard Deviation 4.02 |
| Foot Reflexology First, Then Alternate Nostril Breathing | Change From Baseline in Intraocular Pressure (mmHg) | 90 minutes IOP | 22.7 mm Hg | Standard Deviation 4.33 |