NCT04758689

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 20, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

1 month

First QC Date

February 11, 2021

Last Update Submit

May 2, 2021

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (8)

  • Interleukin 6 (IL-6)

    interleukin 6

    Baseline

  • Interleukin 6 (IL-6)

    interleukin 6

    4 weeks

  • Malondialdehyde (MDA)

    malondialdehyde

    Baseline

  • Malondialdehyde (MDA)

    malondialdehyde

    4 weeks

  • Adenosine Triphosphate (ATP)

    adenosine triphosphate

    Baseline

  • Adenosine Triphosphate (ATP)

    adenosine triphosphate

    4 weeks

  • C-Reactive Protein (CRP)

    C-reactive protein

    Baseline

  • C-Reactive Protein (CRP)

    C-reactive protein

    4 weeks

Secondary Outcomes (4)

  • Rheumatoid Arthritis Quality of Life (RAQoL)

    Baseline

  • Rheumatoid Arthritis Quality of Life (RAQoL)

    4 weeks

  • Health Assessment Questionnaire (HAQ)

    Baseline

  • Health Assessment Questionnaire (HAQ)

    4 weeks

Study Arms (2)

Laser acupuncture and aerobic exercise

EXPERIMENTAL
Combination Product: Laser, exercise, and methotrexate

Aerobic exercise

EXPERIMENTAL
Combination Product: Exercise, and methotrexate

Interventions

Laser, exercise, and methotrexateCOMBINATION_PRODUCT

Laser therapy at acupuncture points, aerobic exercise, and methotrexate

Laser acupuncture and aerobic exercise
Exercise, and methotrexateCOMBINATION_PRODUCT

Aerobic exercise, and methotrexate

Aerobic exercise

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A. Sedky

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 33738615DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

LasersExerciseMethotrexate

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 SuppliesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

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

February 11, 2021

First Posted

February 17, 2021

Study Start

November 20, 2020

Primary Completion

December 20, 2020

Study Completion

December 22, 2020

Last Updated

May 6, 2021

Record last verified: 2021-05

Locations

EG(1)