Efficacy of Fluoroscopic Guided Atlantoaxial Joint Inject... | NCT03606707

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

NCT03606707

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jul 31, 2018Actual

Enrollment

60Estimated

Phase

Early Phase 1

Conditions

Pain, Head
Sleep Disturbance

Interventions

Steroids

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Jul 15, 2018Actual

Completion Date

Aug 1, 2018Estimated

First Submitted Date

Jul 4, 2018

First Submission Date that Met QC Criteria

Jul 23, 2018

First Posted Date

Jul 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2018

Last Update Posted Date

Jul 31, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
corticosteroid	Experimental	steroid group, received intra-articular steroid injection for atlantoaxial joint. , in addition to methotrexate and chloroquine 400 mg per day.	Drug: Steroids
oral steroid	No Intervention	systemic group, received systemic steroid 20 mg/d , in addition to methotrexate and chloroquine 400 mg per day.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Steroids	Drug	intra-articular steroid injection for atlantoaxial joint	corticosteroid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
neck pain	Visual analog scale 0-10	3 months

Secondary Outcomes

Measure	Description	Time Frame
neck disability	Oswestry Neck Pain Questionnaire 0-50	3 months
sleep quality	Pittsburgh sleep quality index	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Manal Hassanien, MD	Contact	01062679200		manal_hassanien@yahoo.com
Abdelraheem Elawamy, MD	Contact	01000032655		arawamyyy@yahoo.com

Overall Officials

Name	Affiliation	Role
Manal Hassanien, MD	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Manal Hassanien	Recruiting	Asyut	Assuit	71111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Types

Study Protocol

Time Frame

3 months

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006261	Headache
D020447	Parasomnias

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013256	Steroids

Ancestor Terms

ID	Term
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided