Effect of Combining Yoga to TENS on Diabetic Glaucoma
Primary Purpose
Diabetes Mellitus, Glaucoma
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
active TENS
sham TENS
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- Faculty of Physical Therapy Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
study group
control group
Arm Description
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
control group will be treated with the same protocol as the study group but with the unit of transcutaneous electrical nerve stimulation is off .
Outcomes
Primary Outcome Measures
Intraoccular pressure measurement
it will be measured in right and left eye
Secondary Outcome Measures
Intraoccular pressure measurement
it will be measured in right and left eye
Intraoccular pressure measurement
it will be measured in right and left eye
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04645992
Brief Title
Effect of Combining Yoga to TENS on Diabetic Glaucoma
Official Title
Effect Yoga in Addition to TENS on Diabetic Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
February 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Active Comparator
Arm Description
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
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
control group will be treated with the same protocol as the study group but with the unit of transcutaneous electrical nerve stimulation is off .
Intervention Type
Device
Intervention Name(s)
active TENS
Intervention Description
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
Intervention Name(s)
sham TENS
Intervention Description
control group will be treated with the same protocol as the study group but with the TENS unit is off .
Primary Outcome Measure Information:
Title
Intraoccular pressure measurement
Description
it will be measured in right and left eye
Time Frame
immediately after the session
Secondary Outcome Measure Information:
Title
Intraoccular pressure measurement
Description
it will be measured in right and left eye
Time Frame
immediately after thirty minutes of session
Title
Intraoccular pressure measurement
Description
it will be measured in right and left eye
Time Frame
immediately after sixty minutes of session end
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
self-representation of gender identity
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy Cairo University
City
Giza
State/Province
Dokki
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com
12. IPD Sharing Statement
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Effect of Combining Yoga to TENS on Diabetic Glaucoma
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