NCT00493753

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
Last Updated

June 28, 2007

Status Verified

June 1, 2007

First QC Date

June 26, 2007

Last Update Submit

June 26, 2007

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • Safety (side effect and adverse event rates), protocol adherence (expected 80% of sessions completed on time)

    6 weeks

Secondary Outcomes (1)

  • pre-post treatment effect size estimates for self-reported pain and fatigue

    6 weeks

Interventions

AcupuncturePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UPMC General Clinical Research Center

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Shadyside Center for Integrative Medicine

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Carol M Greco, Ph.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 26, 2007

First Posted

June 28, 2007

Study Start

November 1, 2004

Study Completion

April 1, 2006

Last Updated

June 28, 2007

Record last verified: 2007-06

Locations

US(2)