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Laser Acupuncture in Rheumatoid Arthritis Geriatric Patients

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laser, exercise, and methotrexate
Exercise, and methotrexate
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

65 Years - 75 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients referred from physician (immunologist) diagnosed with rheumatoid arthritis.

Exclusion Criteria:

  • Patients having the disease overlapping with other connective tissue diseases, such as systematic lupus erythromatosus and systematic sclerosis.
  • History of malignancies.

Sites / Locations

  • A. Sedky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Laser acupuncture and aerobic exercise

Aerobic exercise

Arm Description

Outcomes

Primary Outcome Measures

Interleukin 6 (IL-6)
interleukin 6
Interleukin 6 (IL-6)
interleukin 6
Malondialdehyde (MDA)
malondialdehyde
Malondialdehyde (MDA)
malondialdehyde
Adenosine Triphosphate (ATP)
adenosine triphosphate
Adenosine Triphosphate (ATP)
adenosine triphosphate
C-Reactive Protein (CRP)
C-reactive protein
C-Reactive Protein (CRP)
C-reactive protein

Secondary Outcome Measures

Rheumatoid Arthritis Quality of Life (RAQoL)
rheumatoid arthritis quality of life
Rheumatoid Arthritis Quality of Life (RAQoL)
rheumatoid arthritis quality of life
Health Assessment Questionnaire (HAQ)
health assessment questionnaire
Health Assessment Questionnaire (HAQ)
health assessment questionnaire

Full Information

First Posted
February 11, 2021
Last Updated
May 2, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04758689
Brief Title
Laser Acupuncture in Rheumatoid Arthritis Geriatric Patients
Official Title
Laser Acupuncture in Rheumatoid Arthritis Geriatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
December 22, 2020 (Actual)

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
Studying the effect of laser acupuncture on geriatric patients with rheumatoid arthritis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser acupuncture and aerobic exercise
Arm Type
Experimental
Arm Title
Aerobic exercise
Arm Type
Experimental
Intervention Type
Combination Product
Intervention Name(s)
Laser, exercise, and methotrexate
Intervention Description
Laser therapy at acupuncture points, aerobic exercise, and methotrexate
Intervention Type
Combination Product
Intervention Name(s)
Exercise, and methotrexate
Intervention Description
Aerobic exercise, and methotrexate
Primary Outcome Measure Information:
Title
Interleukin 6 (IL-6)
Description
interleukin 6
Time Frame
Baseline
Title
Interleukin 6 (IL-6)
Description
interleukin 6
Time Frame
4 weeks
Title
Malondialdehyde (MDA)
Description
malondialdehyde
Time Frame
Baseline
Title
Malondialdehyde (MDA)
Description
malondialdehyde
Time Frame
4 weeks
Title
Adenosine Triphosphate (ATP)
Description
adenosine triphosphate
Time Frame
Baseline
Title
Adenosine Triphosphate (ATP)
Description
adenosine triphosphate
Time Frame
4 weeks
Title
C-Reactive Protein (CRP)
Description
C-reactive protein
Time Frame
Baseline
Title
C-Reactive Protein (CRP)
Description
C-reactive protein
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Rheumatoid Arthritis Quality of Life (RAQoL)
Description
rheumatoid arthritis quality of life
Time Frame
Baseline
Title
Rheumatoid Arthritis Quality of Life (RAQoL)
Description
rheumatoid arthritis quality of life
Time Frame
4 weeks
Title
Health Assessment Questionnaire (HAQ)
Description
health assessment questionnaire
Time Frame
Baseline
Title
Health Assessment Questionnaire (HAQ)
Description
health assessment questionnaire
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients referred from physician (immunologist) diagnosed with rheumatoid arthritis. Exclusion Criteria: Patients having the disease overlapping with other connective tissue diseases, such as systematic lupus erythromatosus and systematic sclerosis. History of malignancies.
Facility Information:
Facility Name
A. Sedky
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
33738615
Citation
Adly AS, Adly AS, Adly MS. Effects of laser acupuncture tele-therapy for rheumatoid arthritis elderly patients. Lasers Med Sci. 2022 Feb;37(1):499-504. doi: 10.1007/s10103-021-03287-0. Epub 2021 Mar 19. Erratum In: Lasers Med Sci. 2022 Mar;37(2):1373.
Results Reference
derived

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Laser Acupuncture in Rheumatoid Arthritis Geriatric Patients

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