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Efficacy of Fluoroscopic Guided Atlantoaxial Joint Injection on Head and Neck Pain and Sleep Quality in RA Patients

NCT ID: NCT03606707

Last Updated: 2018-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2018-08-01

Brief Summary

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Efficacy of intra-articular steroid injection for inflamed atlantoaxial joint in patients with rheumatoid arthritis Inclusion criteria Patients with rheumatoid arthritis with MRI findings of atlantoaxial joint inflammation and failure of resolution after 2 weeks systemic steroid administration Exclusion criteria Coagulopathy, allergy to contrast material, pregnancy Interventional group (AS) group, received intra-articular steroid injection for atlantoaxial joint. , in addition to methotrexate and chloroquine 400 mg per day.

Detailed Description

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Efficacy of intra-articular steroid injection for inflamed atlantoaxial joint on sleep quality and head and neck pain in patients with rheumatoid arthritis Inclusion criteria Patients with rheumatoid arthritis with MRI findings of atlantoaxial joint inflammation and failure of resolution after 2 weeks systemic steroid administration Interventional group (AS) group, received intra-articular steroid injection for atlantoaxial joint. , in addition to methotrexate and chloroquine 400 mg per day.

Conditions

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Pain, Head Sleep Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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corticosteroid

steroid group, received intra-articular steroid injection for atlantoaxial joint. , in addition to methotrexate and chloroquine 400 mg per day.

Group Type EXPERIMENTAL

Steroids

Intervention Type DRUG

intra-articular steroid injection for atlantoaxial joint

oral steroid

systemic group, received systemic steroid 20 mg/d , in addition to methotrexate and chloroquine 400 mg per day.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Steroids

intra-articular steroid injection for atlantoaxial joint

Intervention Type DRUG

Other Intervention Names

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cortecosteroid

Eligibility Criteria

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Inclusion Criteria

* Patients with rheumatoid arthritis with MRI findings of atlantoaxial joint inflammation and failure of resolution after 2 weeks systemic steroid administration

Exclusion Criteria

* Coagulopathy, allergy to contrast material, pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Manal Hassanien

principle investigaror

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manal Hassanien, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Manal Hassanien

Asyut, Assuit, Egypt

Site Status RECRUITING

Assiut governorate

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Manal Hassanien, MD

Role: CONTACT

Phone: 01062679200

Email: [email protected]

Abdelraheem Elawamy, MD

Role: CONTACT

Phone: 01000032655

Email: [email protected]

Facility Contacts

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Manal Hassanien, MD

Role: primary

Abdelraheem Elawamy, MD

Role: backup

manal hassanien, MD

Role: primary

MD

Role: backup

Other Identifiers

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Atlantoaxial injection in RA

Identifier Type: -

Identifier Source: org_study_id