Effect of Laser Acupuncture Alone or Combined With Pranayama Exercise on Inflammation in Allergic Rhinitis

September 21, 2022 updated by: Ali Mohamed Ali ismail, Cairo University

Comparing the Effect of Laser Acupuncture Alone or Combined With Pranayama Exercise on Inflammatory Status/Markers in Children With Allergic Rhinitis

Allergic rhinitis (AR) represents one of the most common global health problems with seriously increasing incidence over the last decades.The goal of the treatment of rhinitis is to prevent or reduce the symptoms through reduction of the inflammation of affected tissues. Acupuncture and pranayama yoga exercises had reported a significant improvement in daily symptoms and an increase of symptom-free days in many studies enrolling patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Sixty Egyptian children with allergic rhinitis, after randomization, will be divided to 2 groups; the first 30-children group will receive 2-session per-week laser stimulation for 6 weeks to some selected acupoints and daily pranyama exercises (nearly every session will be one hour, for six weeks), the second group will receive 2-session per-week laser stimulation for six weeks to some bilateral selected acupoints. the stimulated points will be (LI 19, LI 20, ST2, and ST4. ST6, ST7, ST17, ST36, SI18, BL2, GB14, GV24 and EXHN5). Every acupoint will be stimulated with laser power of 100 mw that will be used on a spot area of 1 cm2 for 1 minute.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Cairo Unoversity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • allergic rhinitis children
  • physician-based diagnosis of allergic rhinitis

Exclusion Criteria:

  • children with intellectual disabilities
  • chest disease or heart disease or local congenital nose deformities
  • participants received within-previous-six-months self-prescribed or by-therapist prescribed complementary therapies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pranayama and acupoint stimulation by laser

for 6 weeks,This 30-children group will receive 2-session per-week laser stimulation to some selected acupoints and daily pranyama exercises (nearly every session will be one hour), the stimulated bilateral acupoints will be (LI 19, LI 20, ST2, and ST4. ST6, ST7, ST17, ST36, SI18, BL2, GB14, GV24 and EXHN5). Every acupoint will be stimulated with laser power of 100 mw that will be used on a spot area of 1 cm2 for 1 minute.

this group will receive also pranayama session (applied daily, one hour approximately, for six weeks) will be (alternate nostril pranayama, diaphragmatic pranayama, rapid abdominal pranayama, Bhramari pranayama)
Other: pranayama plus acupoint stimulation by laser

This group will receive 2-session per-week laser stimulation (for six weeks) to some selected acupoints and daily pranyama exercises (nearly every session will be one hour), the stimulated bilateral acupoints will be (LI 19, LI 20, ST2, and ST4. ST6, ST7, ST17, ST36, SI18, BL2, GB14, GV24 and EXHN5). Every acupoint will be stimulated with laser power of 100 mw that will be used on a spot area of 1 cm2 for 1 minute.

this group will receive also pranayama session (applied daily, one hour approximately, for six weeks) composed from (alternate nostril pranayama, diaphragmatic pranayama, rapid abdominal pranayama, Bhramari pranayama ).
Active Comparator: acupoint stimulation by laser
for six weeks, This 30-children group will receive 2-session per-week laser stimulation to some selected acupoints. The stimulated bilateral points will be (LI 19, LI 20, ST2, and ST4. ST6, ST7, ST17, ST36, SI18, BL2, GB14, GV24 and EXHN5). Every acupoint will be stimulated with laser power of 100 mw that will be used on a spot area of 1 cm2 for 1 minute.
Other: acupoint stimulation by laser
This group will receive 2-session per-week laser stimulation (for six weeks) to some selected acupoints. The stimulated bilateral acupoints will be (LI 19, LI 20, ST2, and ST4. ST6, ST7, ST17, ST36, SI18, BL2,GB14, GV24 and EXHN5). Every acupoint will be stimulated with laser power of 100 mw that will be used on a spot area of 1 cm2 for 1 minute.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
erothrocyte sidemention rate
Time Frame: It will be measured after 6 weeks
it is a inflammatory marker in serum
It will be measured after 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunoglobulin E
Time Frame: It will be measured after 6 weeks
it is an antibody in the serum
It will be measured after 6 weeks
interleukin 1-beta
Time Frame: It will be measured after 6 weeks
it is a inflammatory marker in serum
It will be measured after 6 weeks
C-reactive protein
Time Frame: It will be measured after 6 weeks
it is a inflammatory marker in serum
It will be measured after 6 weeks
total eosinophil count
Time Frame: It will be measured after 6 weeks
it is a inflammatory marker in serum
It will be measured after 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

September 21, 2022

First Submitted That Met QC Criteria

September 21, 2022

First Posted (Actual)

September 23, 2022

Study Record Updates

Last Update Posted (Actual)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 21, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/003341

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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