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Effect of Laser Puncture on Rheumatoid Arthritis Patients

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laser
Control
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:

  • 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

Sites / Locations

  • M. Sedky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laser Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

HAQ (Change)
Health Assessment questionnaire
RAQoL (Change)
Rheumatoid Arthritis Quality of Life
CRP (Change)
Analysis of serum C-reactive protein
IL-6 (Change)
Plasma interleukin-6 inflammatory markers
ATP (Change)
Plasma ATP concentration anti-oxidant marker
MDA (Change)
plasma malondialdehyde oxidative marker

Secondary Outcome Measures

Full Information

First Posted
December 16, 2020
Last Updated
December 31, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04684693
Brief Title
Effect of Laser Puncture on Rheumatoid Arthritis Patients
Official Title
Effect of Laser Puncture on Rheumatoid Arthritis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 25, 2020 (Actual)
Primary Completion Date
January 20, 2021 (Anticipated)
Study Completion Date
January 22, 2021 (Anticipated)

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 puncture on rheumatoid arthritis patients

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 Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Laser
Intervention Description
Laser puncture and exercise
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
Exercise
Primary Outcome Measure Information:
Title
HAQ (Change)
Description
Health Assessment questionnaire
Time Frame
Pre-intervention, 4 weeks
Title
RAQoL (Change)
Description
Rheumatoid Arthritis Quality of Life
Time Frame
Pre-intervention, 4 weeks
Title
CRP (Change)
Description
Analysis of serum C-reactive protein
Time Frame
Pre-intervention, 4 weeks
Title
IL-6 (Change)
Description
Plasma interleukin-6 inflammatory markers
Time Frame
Pre-intervention, 4 weeks
Title
ATP (Change)
Description
Plasma ATP concentration anti-oxidant marker
Time Frame
Pre-intervention, 4 weeks
Title
MDA (Change)
Description
plasma malondialdehyde oxidative marker
Time Frame
Pre-intervention, 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: 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
Facility Information:
Facility Name
M. Sedky
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
33966520
Citation
Adly AS, Adly AS, Adly MS, Ali MF. A novel approach utilizing laser acupuncture teletherapy for management of elderly-onset rheumatoid arthritis: A randomized clinical trial. J Telemed Telecare. 2021 Jun;27(5):298-306. doi: 10.1177/1357633X211009861. Epub 2021 May 9.
Results Reference
derived

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Effect of Laser Puncture on Rheumatoid Arthritis Patients

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