- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04758689
Laser Acupuncture in Rheumatoid Arthritis Geriatric Patients
May 2, 2021 updated by: A. Sedky, Cairo University
Studying the effect of laser acupuncture on geriatric patients with rheumatoid arthritis
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
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 Locations
-
-
-
Cairo, Egypt
- A. Sedky
-
-
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
65 years to 75 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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: Aerobic exercise
|
Aerobic exercise, and methotrexate
|
|
Experimental: Laser acupuncture and aerobic exercise
|
Laser therapy at acupuncture points, aerobic exercise, and methotrexate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interleukin 6 (IL-6)
Time Frame: Baseline
|
interleukin 6
|
Baseline
|
|
Interleukin 6 (IL-6)
Time Frame: 4 weeks
|
interleukin 6
|
4 weeks
|
|
Malondialdehyde (MDA)
Time Frame: Baseline
|
malondialdehyde
|
Baseline
|
|
Malondialdehyde (MDA)
Time Frame: 4 weeks
|
malondialdehyde
|
4 weeks
|
|
Adenosine Triphosphate (ATP)
Time Frame: Baseline
|
adenosine triphosphate
|
Baseline
|
|
Adenosine Triphosphate (ATP)
Time Frame: 4 weeks
|
adenosine triphosphate
|
4 weeks
|
|
C-Reactive Protein (CRP)
Time Frame: Baseline
|
C-reactive protein
|
Baseline
|
|
C-Reactive Protein (CRP)
Time Frame: 4 weeks
|
C-reactive protein
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rheumatoid Arthritis Quality of Life (RAQoL)
Time Frame: Baseline
|
rheumatoid arthritis quality of life
|
Baseline
|
|
Rheumatoid Arthritis Quality of Life (RAQoL)
Time Frame: 4 weeks
|
rheumatoid arthritis quality of life
|
4 weeks
|
|
Health Assessment Questionnaire (HAQ)
Time Frame: Baseline
|
health assessment questionnaire
|
Baseline
|
|
Health Assessment Questionnaire (HAQ)
Time Frame: 4 weeks
|
health assessment questionnaire
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
November 20, 2020
Primary Completion (Actual)
December 20, 2020
Study Completion (Actual)
December 22, 2020
Study Registration Dates
First Submitted
February 11, 2021
First Submitted That Met QC Criteria
February 13, 2021
First Posted (Actual)
February 17, 2021
Study Record Updates
Last Update Posted (Actual)
May 6, 2021
Last Update Submitted That Met QC Criteria
May 2, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
Other Study ID Numbers
- REC/002-2021
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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