- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04684693
Effect of Laser Puncture on Rheumatoid Arthritis Patients
December 31, 2020 updated by: A. Sedky, Cairo University
Studying the effect of laser puncture on rheumatoid arthritis patients
Study Overview
Status
Unknown
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
- M. 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:
- Meeting the criteria of ACR classification for rheumatoid arthritis
- Meeting the criteria of EULAR classification for rheumatoid arthritis
Exclusion Criteria:
- Having malignancy
- Having connective tissue disease
- Smokers
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 |
|---|---|
|
Active Comparator: Control Group
|
Exercise
|
|
Experimental: Laser Group
|
Laser puncture and exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HAQ (Change)
Time Frame: Pre-intervention, 4 weeks
|
Health Assessment questionnaire
|
Pre-intervention, 4 weeks
|
|
RAQoL (Change)
Time Frame: Pre-intervention, 4 weeks
|
Rheumatoid Arthritis Quality of Life
|
Pre-intervention, 4 weeks
|
|
CRP (Change)
Time Frame: Pre-intervention, 4 weeks
|
Analysis of serum C-reactive protein
|
Pre-intervention, 4 weeks
|
|
IL-6 (Change)
Time Frame: Pre-intervention, 4 weeks
|
Plasma interleukin-6 inflammatory markers
|
Pre-intervention, 4 weeks
|
|
ATP (Change)
Time Frame: Pre-intervention, 4 weeks
|
Plasma ATP concentration anti-oxidant marker
|
Pre-intervention, 4 weeks
|
|
MDA (Change)
Time Frame: Pre-intervention, 4 weeks
|
plasma malondialdehyde oxidative marker
|
Pre-intervention, 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)
December 25, 2020
Primary Completion (Anticipated)
January 20, 2021
Study Completion (Anticipated)
January 22, 2021
Study Registration Dates
First Submitted
December 16, 2020
First Submitted That Met QC Criteria
December 23, 2020
First Posted (Actual)
December 24, 2020
Study Record Updates
Last Update Posted (Actual)
January 5, 2021
Last Update Submitted That Met QC Criteria
December 31, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/010-2020
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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