NCT04684693

Brief Summary

Studying the effect of laser puncture on rheumatoid arthritis patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

December 25, 2020

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2021

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

26 days

First QC Date

December 16, 2020

Last Update Submit

December 31, 2020

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (6)

  • HAQ (Change)

    Health Assessment questionnaire

    Pre-intervention, 4 weeks

  • RAQoL (Change)

    Rheumatoid Arthritis Quality of Life

    Pre-intervention, 4 weeks

  • CRP (Change)

    Analysis of serum C-reactive protein

    Pre-intervention, 4 weeks

  • IL-6 (Change)

    Plasma interleukin-6 inflammatory markers

    Pre-intervention, 4 weeks

  • ATP (Change)

    Plasma ATP concentration anti-oxidant marker

    Pre-intervention, 4 weeks

  • MDA (Change)

    plasma malondialdehyde oxidative marker

    Pre-intervention, 4 weeks

Study Arms (2)

Laser Group

EXPERIMENTAL
Device: Laser

Control Group

ACTIVE COMPARATOR
Procedure: Control

Interventions

LaserDEVICE

Laser puncture and exercise

Laser Group
ControlPROCEDURE

Exercise

Control Group

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Meeting the criteria of ACR classification for rheumatoid arthritis
  • Meeting the criteria of EULAR classification for rheumatoid arthritis

You may not qualify if:

  • Having malignancy
  • Having connective tissue disease
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M. Sedky

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 33966520DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Lasers

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 24, 2020

Study Start

December 25, 2020

Primary Completion

January 20, 2021

Study Completion

January 22, 2021

Last Updated

January 5, 2021

Record last verified: 2020-12

Locations

EG(1)