Ocular HypertensionNCT02993445
Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension
A study testing Alternate Nostril Breathing and Foot Reflexology in people with Ocular Hypertension, run by Temple University.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Hypertension
- What is being tested?
- Alternate Nostril Breathing and Foot Reflexology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with ocular hypertension
Who cannot join
- 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
About this study
Official title: A Pilot Study on the Effect of Alternate Nostril Breathing and Foot Reflexology on Intraocular Pressure in Ocular Hypertension
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.
Read the 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.
- Conditions
- Ocular Hypertension
- Being tested
- Alternate Nostril Breathing, Foot Reflexology
- Medical subject headings
- Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternate Nostril BreathingOther
Foot ReflexologyDevice
| Study group | Role | What they receive |
|---|---|---|
| Alternate Nostril Breathing | Experimental | 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. Receives: Other: Alternate Nostril Breathing |
| Foot Reflexology | Experimental | 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. Receives: Device: Foot Reflexology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
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
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startSep 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ocular HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Henderer, M.D., Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993445
- Sponsor's protocol ID
- 22105
- Status last verified
- Nov 2020
- First submitted
- 8 Dec 2016
- Last updated
- 27 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Effect of Alternate Nostril Breathing and Foot Reflexology on Intraocular Pressure in Ocular Hypertension
- ClinicalTrials.gov ID
- NCT02993445
- Acronym / sponsor ID
- 22105
- Conditions
- Ocular Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Posted 27 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternate Nostril Breathing | Experimental | Other: Alternate Nostril BreathingThe 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. |
| Foot Reflexology | Experimental | Device: Foot ReflexologyThe 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. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with ocular hypertension
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alternate Nostril Breathing | Other | Alternate Nostril Breathing |
| Foot Reflexology | Device | Foot Reflexology |
Primary outcome
Change From Baseline in Intraocular Pressure (mmHg)
Time frame: 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)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Henderer, M.D. principal investigator
Temple University
Questions about this trial
What is this clinical trial studying?
A study testing Alternate Nostril Breathing and Foot Reflexology in people with Ocular Hypertension, run by Temple University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Intraocular Pressure (mmHg) (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.