Effect of Combining Yoga to TENS on Diabetic Glaucoma

NCT ID: NCT04645992

Last Updated: 2020-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-20

Study Completion Date

2021-02-01

Brief Summary

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Intraocular pressure (IOP) is maintained by a balance between aqueous production and outflow with an imbalance leading to elevated eye pressure. Very high levels of IOP will subject retinal cells to mechanical stress. In addition to mechanical injury, IOP elevation can impair ocular blood flow reducing perfusion pressure to retinal neurons. Long-term vascular and mechanical stresses can produce further injury at the optic nerve.

Elevated intraocular pressure (IOP) or ocular hypertension (OHT) is the only well-established modifiable risk factor for primary open-angle glaucoma (POAG), the most common form of glaucoma. Glaucoma is a class of optic neuropathy. It is main leading cause of blindness.

Glaucoma is classified on the basis of anatomic features as open angle (where the anterior chamber angle of the eye remains open) and angle-closure (with closure of the anterior chamber angle). Glaucoma is considered primary if the eye has no preexisting disease. Secondary forms of glaucoma are caused by various ocular or systemic diseases such as pigment dispersion syndrome and ocular trauma.

It seems reasonable to consider that a longer duration of diabetes mellitus (DM) with a prolonged insult to the retina and optic nerve via vascular, glial, and neuronal factors would be associated with a higher risk of OAG.

Detailed Description

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patients with diabetic glaucoma (80 patients ) from both sexes will be divided to 2 groups, 40 patients for each group;

study group will receive only one session of 20 minutes yoga ocular training for 20 minutes followed by transcutaneous electrical nerve stimulation (TENS) by placing electrodes on skin over urinary bladder (BL) acupoints 61 and 62 for 20 minutes

control group will be treated with the same protocol as the study group but with the TENS unit is off.

Conditions

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Diabetes Mellitus Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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study group

study group will receive only one session of yoga eye exercise for 20 minutes followed by transcutaneous electrical nerve stimulation by placing electrodes on skin over urinary bladder (BL) acupoints 61 and 62 for 20 minutes

Group Type ACTIVE_COMPARATOR

active TENS

Intervention Type DEVICE

study group will receive only one session of yoga eye exercise for 20 minutes followed by TENS by placing electrodes on skin over urinary bladder (BL) acupoints 61 and 62 for 20 minutes

control group

control group will be treated with the same protocol as the study group but with the unit of transcutaneous electrical nerve stimulation is off .

Group Type SHAM_COMPARATOR

sham TENS

Intervention Type DEVICE

control group will be treated with the same protocol as the study group but with the TENS unit is off .

Interventions

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active TENS

study group will receive only one session of yoga eye exercise for 20 minutes followed by TENS by placing electrodes on skin over urinary bladder (BL) acupoints 61 and 62 for 20 minutes

Intervention Type DEVICE

sham TENS

control group will be treated with the same protocol as the study group but with the TENS unit is off .

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with DM duration more than 5 years .
* BMI will be \< 30 kg/m² .
* patients with bilateral primary open-angle glaucoma.

Exclusion Criteria

* acute or chronic eye inflammation
* cataract
* eye surgeries
* mental ill patients
* patients who will refuse to participate in the study
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ali Mohamed Ali ismail

lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali Ismail, lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Faculty of Physical Therapy Cairo University

Giza, Dokki, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ali Ismail, lecturer

Role: CONTACT

Phone: 02 01005154209

Email: [email protected]

Facility Contacts

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Ali Ismail, lecturer

Role: primary

Other Identifiers

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P.T.REC/012/002604

Identifier Type: -

Identifier Source: org_study_id