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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05915507

Collaborator

(none)

Enrollment

Location

Arms

5.8

Anticipated Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 geriatric patients.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Other: pranayama plus acupoint stimulation by laser Other: acupoint stimulation by laser	N/A

Detailed Description

Sixty Egyptian geriatrics with allergic rhinitis, after randomization, will be divided to 2 groups; the first 30-geriatric group will receive 3-session per-week laser stimulation for 8 weeks to some selected acupoints and daily pranyama exercises (nearly every session will be one hour, for 8 weeks), the second group will receive 3-session per-week laser stimulation for eight 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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 5, 2023

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pranayama and acupoint stimulation by laser the 30-geriatric group will receive 3-session per-week laser stimulation for 8 weeks to some selected acupoints and daily pranyama exercises (nearly every session will be one hour, for 8 weeks), 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.	Other: pranayama plus acupoint stimulation by laser This group will receive 3-session per-week laser stimulation (for eight 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 eight weeks) composed from (alternate nostril pranayama, diaphragmatic pranayama, rapid abdominal pranayama, Bhramari pranayama )
Active Comparator: acupoint stimulation by laser the 30-geriatric group will receive 3-session per-week laser stimulation for 8 weeks to some selected acupoints (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 3-session per-week laser stimulation (for eight 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.

Arm

Intervention/Treatment

Experimental: pranayama and acupoint stimulation by laser

the 30-geriatric group will receive 3-session per-week laser stimulation for 8 weeks to some selected acupoints and daily pranyama exercises (nearly every session will be one hour, for 8 weeks), 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.

Other: pranayama plus acupoint stimulation by laser

This group will receive 3-session per-week laser stimulation (for eight 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 eight weeks) composed from (alternate nostril pranayama, diaphragmatic pranayama, rapid abdominal pranayama, Bhramari pranayama )

Active Comparator: acupoint stimulation by laser

the 30-geriatric group will receive 3-session per-week laser stimulation for 8 weeks to some selected acupoints (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 3-session per-week laser stimulation (for eight 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.

Outcome Measures

Primary Outcome Measures

erothrocyte sidemention rate [It will be measured after 8 weeks]
it is a inflammatory marker in serum

Secondary Outcome Measures

Immunoglobulin E [It will be measured after 8 weeks]
it is an antibody in the serum
interleukin 1-beta [It will be measured after 8 weeks]
it is a inflammatory marker in serum
C-reactive protein [It will be measured after 8 weeks]
it is a inflammatory marker in serum
total eosinophil count [It will be measured after 8 weeks]
it is a inflammatory marker in serum

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

geriatrics with allergic rhinitis

Exclusion Criteria:

chest disease or heart disease or local congenital nose deformities participants received within-previous-eight-months self-prescribed or by-therapist prescribed complementary therapies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Physical Therapy Cairo University	Giza	Dokki	Egypt

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Ali MA Ismail, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ali Mohamed Ali ismail, lecturer of physical therapy for Internal Medicine and Geriatrics, Cairo University

ClinicalTrials.gov Identifier:

NCT05915507

Other Study ID Numbers:

P.T.REC/012/004534

First Posted:

Jun 23, 2023

Last Update Posted:

Jun 23, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rhinitis

Rhinitis, Allergic

Study Results

No Results Posted as of Jun 23, 2023