Feasibility and Safety of Acupuncture for Systemic Lupus | NCT00493753

Studies
Feasibility and Safety of Acupuncture for Systemic Lupus

NCT00493753

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Jun 28, 2007Estimated

Enrollment

24Actual

Phase

Not Applicable

Conditions

Systemic Lupus Erythematosus

Interventions

Acupuncture

Countries

United States

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

Jun 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2004

Primary Completion Date

Not provided

Completion Date

Apr 2006Actual

First Submitted Date

Jun 26, 2007

First Submission Date that Met QC Criteria

Jun 26, 2007

First Posted Date

Jun 28, 2007Estimated

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

Jun 26, 2007

Last Update Posted Date

Jun 28, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this pilot study was to evaluate whether acupuncture is safe and acceptable to people with systemic lupus erythematosus (SLE). Twenty-four SLE patients were assigned randomly to receive either 10 sessions of acupuncture, 10 sessions of a minimal-needling control intervention, or their usual medical care alone. It was hypothesized that acupuncture would be safe for people with SLE, and that participants would be able to complete their assigned treatment within 5 to 6 weeks.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Name	Type	Description	Arm Group Labels	Other Names
Acupuncture	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety (side effect and adverse event rates), protocol adherence (expected 80% of sessions completed on time)		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
pre-post treatment effect size estimates for self-reported pain and fatigue		6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosed with SLE, 18 years old or older, pain duration at least 3 times per week for at least 3 months, medications and doses stable for the past month, able to speak, read, and understand English, and provide informed consent.

Exclusion Criteria:

known pregnancy, active uncontrolled organ involvement, steroid dose greater than 10 mg per day, platelets < 100,000, previous course of acupuncture treatment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carol M Greco, Ph.D.	University of Pittsburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UPMC General Clinical Research Center		Pittsburgh	Pennsylvania	15213	United States
UPMC Shadyside Center for Integrative Medicine

Condition Browse Module

MeSH Terms

ID	Term
D008180	Lupus Erythematosus, Systemic

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015670	Acupuncture Therapy

Ancestor Terms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided